Robert Morris is helming a biotech-focused stock newsletter that’s called Biotech Supertrader (modesty has no place in the world of newsletter promotions, of course), and I’ve never covered this letter before so I thought I ought to have a look at the latest teaser we’ve been asked about.
Morris, incidentally, has been featured in our pages before — but that was back when he was editor of China Stock Insider at the same publisher. That letter, like almost all China-focused investment newsletters, seems to have disappeared quietly into that good night … which probably tells you that it’s time to invest in China again, since the newsletter publishers are ignoring the Middle Kingdom and rushing out their pitches about biotech and tech stocks. At the time, Morris was teasing NQ Mobile (NQ), which has turned out to be pretty good if you bought it down there in the $6-8 neighborhood (though it’s been a wild ride).
So now what’s he pitching for his Biotech Supertrader?
Well, the destruction of “Man’s deadliest disease”, of course. Here’s how the teaser gets our attention:
“This Tiny, Unknown Biotech is About to Unleash Its ‘Holy Grail’ Drug on Man’s Deadliest Disease
“Their ‘Guided Missile Approach’ Could Save Thousands of Lives Each Year
“It’s about to become the most talked about advancement in cancer treatment in our lifetimes and you can lock in a life-transforming fortune if you act quickly….
“I’m urging my subscribers to load up on this stock NOW….
“I’ve just uncovered a tiny, unknown biotechnology company with a new cancer drug in phase 3 clinical trials which is showing remarkable success at treating several types of cancer.
“Their scientists have found an innovative approach to cancer care which involves a breakthrough in treatment. It goes deep inside the inner workings of our cells.
“Plus, this medicine looks to be many times more effective and with fewer side effects than the chemo, radiation, and drug therapies currently available.”
If there’s one thing that investors know can make them rich and make them feel good about themselves and the world, it’s a cure for cancer — we’ve seen that effective cancer treatments can and do (occasionally) turn little biotech stocks into gigantic successes, so the dream lives on that you’re going to catch one of these lottery tickets and own the next Genentech. Will we be so lucky? Well, let’s see which one he’s pitching:
“When this drug wins FDA approval – which I believe it will – this small company’s $4.16 stock price will go straight to the moon.
“And the market for this drug is absolutely huge!
“You see, this small biotech is targeting its new drug, let’s call it ‘drug S’, at cancers of the blood and bone marrow. And it is already in very promising phase 3 trials for these two types of cancer.
“But here’s where it gets really interesting. It looks like the drug this company is developing will also work on other types of cancer!
“There are positive signs it works on Non-Small Cell Lung Cancer (NSCLC) too. There are 1.1 million people with this type of malignancy. Just in the United States alone there are over 300,000 patients with this disease according to The American Cancer Society. Each desperate for a cure.
“Plus it looks like ‘drug S’ may turn out to be an effective treatment for ovarian Cancer. There are more than 204,000 new cases of ovarian cancer diagnosed worldwide each year with 22,280 of these in the United States according to the National Cancer Institute estimates.”
So … who is it? Thinkolator sez this is Cyclacel Pharmaceuticals (CYCC)
Cyclacel is indeed a little biotech around $4 (it closed at $4.35 yesterday), with a market capitalization of only about $80 million — so be careful, we’re a big enough group here that if just a small percentage of Stock Gumshoe readers got enthused about this stock it could drive the shares up, less than a million dollars worth of shares trade each day (Biotech Supertrader says they limited their readership to 750 people — I don’t know if that’s still their cap or if they’ve hit it, but we’ll have more folks than that reading this free article).
And like many biotech stocks, it’s got some impressive scientists and it’s been losing money for a long time as they’ve been searching for a viable drug (their current lead drug also was a big focus of theirs back when it was in Phase 1 trials five or more years ago, so that’s a good reminder of the time these things take, it’s just starting Phase 3 trials now). It looks like they must have gone public in 2004, when they were about eight years old, and a quick scan of ten years of their financials over at Morningstar indicates that they’ve never generated more than a token amount of revenue (meaning, they’ve probably had some research collaboration payments or partnership funding, but never got a product to market), and have accumulated more than $250 million in losses to date. And had two reverse splits to keep the price from sinking far into penny territory.
So that’s not unusual, but it means that — as with all developmental-stage biotechs — it’s not about the financials or the fundamentals, it’s about what’s going to happen in their clinical trials and whether things are going well enough that they can continue to finance the trials … which get much more expensive as you progress through Phase 2 and Phase 3.
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All I know about them so far is that they say they’ve got enough cash to get through enrollment in their key Phase 3 study for “drug S” (which is sapacitabine) as of September when they last updated their investor presentation, but I know nothing about the science or the competing cancer drugs that are out there or how fabulous this particular one might be, so I asked our favorite medical writer, Doc Gumshoe (who, yes, is not a doctor) to check them out quickly and chime in. Here’s what he could share after looking into them for a few minutes (he’s just looking at the medical stuff, not so much the “investor presentations”):
- Cyclacel’s Prospects
Cyclacel has three drugs in development at this time, and is involved in eight clinical trials with these drugs, not including two clinical trials that have been terminated. Their top contender is sapacitabine which targets the division of cancer cells. If you can prevent cancer cells from dividing and reproducing, you have the cancer whipped, so targeting cancer cell division (or mitosis, which is the technical term) is a highly promising avenue for treating cancer. However, we need to take note of the fact that sapacitabine is one of a large number of drugs that propose to fight cancer by this method.
At present, all eight of Cyclacel’s clinical trials involve sapacitabine. Of these, at least one has been completed – a Phase 1 study of the safety and pharmacology of the drug. Four others are current, with no information about results. These are likely Phase 1 or small Phase 2 studies, to assess safety, determine what a correct dose might be, and evaluate whether the drug does what it’s supposed to do in human subjects with the target diseases, which in this case include acute myeloid leukemia (AML), cutaneous T-cell lymphoma, and some advanced solid tumors. Prior to the clinical trials, sapacitabine has demonstrated impressive results in delaying the spread of metastatic liver cancers in mice.
From what I can gather from public sources (i.e., the NIH Clinical Trials Registry), there is one Phase 3 trial, which started recruiting patients in February of 2013 and is expected to be completed in late 2015. The trial is in elderly patients with AML, and compares alternating cycles of sapacitabine and decitabine with decitabine alone. Decitabine (Dacogen) is FDA-approved for treating AML and also targets cancer cells’ replication by attacking their DNA.
It is possible that the Phase 3 trial by itself could lead to FDA approval for sapacitabine, depending on the strength of the results. However, that trial would not get the drug approved for use as monotherapy, since it is not being investigated as monotherapy. My guess is that Cyclacel is planning more trials of sapacitabine as monotherapy, perhaps in younger patients. And my further guess is that FDA approval is still quite a long way off.
Sapacitabine is also in a Phase 3 trial with cyclophosphamide and rituximab for the treatment of relapsed chronic lymphocytic leukemia. Cyclophosphamide (marketed under several trade names) is a well-established chemotherapy agent used in a number of cancers, and has led to remission in many cases; however, it is associated with truly harrowing adverse effects. Rituximab (Rituxan, Genentech) is used not only in cancers but in some autoimmune diseases. And sapacitabine is also being studied in patients with previously-treated non-small-cell lung cancers.
Although the piece from Biotech Supertrader said that the drug – identified as “drug S” –is also a promising treatment for ovarian cancer, I find no clue that it is being studied in such patients. [ed note: that’s because that “promise” is in the lab still, not in people — they had a press release about this in the Fall, “75% of Ovarian Cancer Patient Samples Highly Sensitive to Sapacitabine”, not studied in patients but on patient samples]
Cyclacel has two other drugs in development: selicilib and a drug designated as CYC116. One selicilib study has been terminated, and in a second Phase 1 study, selicilib is used with sapacitabine in patients with advanced solid tumors. Remember, however, that Phase 1 studies are many rungs of the ladder below what’s needed to gain FDA approval.
CYC116 is an aurora kinase inhibitor, meaning that it blocks the action of an intracellular enzyme that facilitates cancer cell mitosis. This is a promising avenue of cancer treatment, however, the traffic on this avenue is fairly heavy, and includes several other classes of drugs including tyrosine kinase inhibitors, and taxol based agents such as paclitaxel (Taxol, Bristol Myers Squibb); docetaxel (Taxotere, Sanofi-Aventis), Abraxane (a newer formulation of paclitaxel from Celgene) and others.
CYC116 supposedly also inhibits vascular endothelial growth factor (VEGF), which induces the growth of blood vessels that nourish cancer cells. Inhibiting VEGF is a well-established means of combating cancer, and CYC116 could hardly be characterized as a radically new departure in cancer treatment.
The one trial involving this agent has been terminated. That, of course, does not mean that development of CYC116 stops dead in its tracks – there are many reasons why a trial can be terminated, and ours is not to speculate without more information.
Beyond those three drugs, it’s hard to guess what Cyclacel may have up its corporate sleeve. It is certainly true that a successful cancer drug – even if only moderately successful– can be transformational for the biotech that develops the drug. But the drugs that Cyclacel has under development do not appear to this skeptical observer to be radically new departures in cancer treatment.
It’s important to remember, when trying to estimate the likelihood of a single drug demonstrating sufficient efficacy and safety to gain FDA approval and market share, that the competitive field is vast. As I mentioned earlier, Cyclacel has a total of 8 clinical trials in process at this time.
For the sake of perspective, it’s worth knowing that at present there are 41,445 cancer trials being conducted. So those are the odds.
So there you have it — it’s almost impossible to find a development-stage biotech whose financials look great or that makes your heart go pit-a-pat over their valuation, especially in a biotech bull market like we’ve seen over the past year or so, and Cyclacel doesn’t jump out as spectacular on that front either, not unless you’re a big believer in the promise of their specific drug. They’re a small stock and they don’t get much attention, other than from the analysts who probably helped them sell shares in secondary offerings in recent years, and there aren’t any major “skin in the game” insiders as far as I can tell (the CEO owns $1 million worth of shares, but he gets paid more than that every year), and there’s only one really focused owner on the institutional side that seems to have any kind of biotech focus (Eastern Capital owns about 7% of the shares, roughly $5 million worth … don’t know much about them).
So I don’t see a lot to make them stand out other than Robert Morris’ apparent enthusiasm for the shares (which certainly goes over the top, he calls his special report “The End of Cancer Worries Forever“), and I don’t know enough about the science to be a believer (though, to be fair, I almost never speculate on developmental biotechs because they’re so hit-driven and I’m not smart enough to be a hit-picker in the sector). It is at least encouraging that they are enrolling patients for Phase 3, and that they probably won’t have to raise more money before they have some indication of how the trial is going, but sometime in the next year or two they’re probably going to have to either get good results from this trial that let them raise cash at a good price, or have promising enough results that some big pharma company wants to jump in and help fund development of “drug S” (or just buy up the whole company, as happens with some regularity when a little biotech gets promising results).
Oh, and they are presenting at an investor conference next week, so maybe they’ll have something interesting to share then. As you can tell, this one doesn’t jump into my cup of tea … but these kinds of stocks almost never do. Sound interesting to you? Interested in the science or the lottery-ticket possibilities of $80-million developmental biotechs? Have any experience with Robert Morris or know whether or not we should consider him a biotech savant? Let us know with a comment below.
I cannot believe what happened today with Intercept Pharma. Up 280 per cent! Its drug candidate obeticholic acid reverses NASH by agonizing the hepatocyte nuclear farnesoid X receptor. This was in the so-called FLINT trial, which was stopped early (it was to finish in late 2014) because data were so amazingly good. Better yet, NIDDK funded the study for them.
I didn’t know about this company, but if I had I would have sunk money into it, as the science is solid. The question is whether to buy it now. They will pursue other indications for the drug such as primary biliary cirrhosis. This drug, which is benign and nontoxic, really has blockbuster status, as 10 per cent of the world’s population has fatty liver disease.
Look at SBOTF; XNCR and MDFZF for great micro and nano biotech opportunities. Stellar Biotech, Xencor and Medifocus have super upsides and limited downsides (besides volatility). Medifocus is a nano under 25cents and it actually has a revenue producing approved medical treatment for benign enlarged prostate called the Prolieve System. They have a stage 3 medical device/treatment for breast cancer that looks very good in early trials and will be a blockbuster once approved. It will likely have many tumor applications besides for breast cancer. All this for 25 cents!
Great news for Intercept investors and fatty liver disease sufferers karma. I’m hoping for a day like this at some point in the next three years related to one or more of my investments.
David B: XNCR is on an absolute tear these weeks. Any idea why? With a preliminary search I can find no news. Tell us more.
Medifocus looks interesting, except that haven’t all its Prolieve interests and assets gone to Boston Sci? Will they continue to get revenue from Prolieve? What do you think?
I plan on doing some background reading on Stellar’s science, and will get back to you on that one. Not clear on what a catalyst for appreciation would be on this one.
Xencor has a very promising pipeline and is in my favorite field–immunology. There’s an excellent article on Seeking Alpha from about two months agao. You can read a lot about Stellar on this site’s thread started by our newest professional contributor–the Blind Squirrel (Jim Skelton). It’s got basically a monopoly on the production of KLH which is an unbelievably good catalyst for vaccines and any immunotherapy. It has it’s own drug in trial for C. Difficile and their are a boatload of companies with compounds in trials using KLH. I didn’t even mention Rexahn (RNN)which I bought on 1/02/14 as it was new to me, but it has exploded the past several days on superb trial news. There are several articles on SA regarding RNN. I think I was more lucky than good on this one–right place at the right time.
Oh, and regarding Medifocus–they now have exclusive rights to the Prolieve System KarmaSwami. Medifocus and Stem Cell Therapeutics SCTPS are my favorite nanocaps. In my opinion, the risk reward formula is superb for each of these–speculative? perhaps, but I like the risk reward and valuation as opposed to something like Twitter or Tesla.
There is so much to talk about, I can’t possibly cover everything in a short comment.
The coverage of CYCC here has been lukewarm. A lot of completely unrelated stocks has been suggested as a better use of your time for further research and two related supposedly more exciting drugs.
What I want to emphasize is that researching CYCC further is a good use of your time.
I am not going to comment on completely unrelated stocks, but as for the two supposedly more exciting drugs – all I can say is that they are not a competitive threat – that’s definitely not what you should be worried about – and the companies involved (AMBI and NVS, respectively) are not better investments.
Remember that exciting from the point of view of an investor is not the same thing as exciting from the point of view of a doctor. Although, for sure, they can coincide in some cases. But if a company developing a wonderdrug with peak sales of $1B/year has a $100B marketcap, it is not an exciting investment and if a boring business consisting of just one $100 bill and nothing else sells for $1, then, it is a good investment.
Safety and tolerability of CYCC’s main drug is also not something you should be worried about. It is a deadly disease, the approved and off-label alternative treatments are EXTRAORDINARY toxic. Both the FDA and Data Safety Monitoring Boards reviewed the safety.
That’s all for now. I’ll write another short message later about where the excitement is with CYCC.
Sapacitabine probably will be approved for AML, but does it matter? Right now there are 106 molecules in development for AML, and 101 of those are first-in-class. Fully 12 are in phase III. Clofarabine looks very promising, and azacytidine is on the market. Imatinib and dasatinib are being studied as repurposed drugs for AML. There will be HDACs and Aurora kinase inhibitors, There will be tosedostat and vosaroxin, and none of this takes into account the old agent UPI-928, an already approved agent with activity against AML that has never been marketed because of corporate drama, not because it is ineffective. In sort, the pipeline contains a torrent. I see little reason to think that sapacitabine will emerge from all of this flux in any sort of dominent position. My prediction is that the future of AML therapy will belong to combinations of agents and will subsume immune-mediated therapies and apoptosis restorers. Nucleoside analogs may not matter. I would be long on the sector, but not on Cyclacel. Pity there is no AML ETF.
“There will be tosedostat and vosaroxin, and none of this takes into account the old agent UPI-928, an already approved agent with activity against AML that has never been marketed because of corporate drama, ”
Sure thing. Drugs that can save lives are kept off the market not because they don’t work, but because of “corporate drama”. Your silly “facts” are wearing thin.
Not sure who put a bee in your bonnet truthseeker, but you ad hominem disgruntlement and blanket dismissal are definitely not cool. I don’t see you presenting any facts or presenting any enlightened disquisition, You just lash out gratuitously. Maybe you are constipated?
I can name quite a few excellent drugs ensnared in corporate drama. And as to UPI-928, please read this, or as Bill Buckley used to say, have someone read it to you.
http://www.marketwatch.com/story/update-pharma-and-resolute-oncology-sign-binding-term-sheet-to-merge-2013-09-09
Lots of effective drugs are never developed and so ‘kept off the market.’
Quite often it is due to IP or fiscal matters (not profitable enough).
The smaller companies tend to have a lower profit expectation than big pharma.
Even perceptions of safety (real or not) can stop development. That is one reason why we don’t have more vaccine adjuvants.
You are quite right George. In the days before DAA’s for HCV, the single best and most potent interferon-alfa (consensus IFN, Infergen) disappeared from the market despite having ten times the antiviral efficacy of the alfas by Roche and Schering. It disappeared because of bad dealmaking by its developer Amgen. It resurfaced in the hands of Valeant, who acknowledged its greatness, but then sold it in a CEO shake-up to raise cash for another acquisition. It went to Three Rivers, and on to Kadmon. It cured 70 per cent of the patients with HCV genotype one that got it, a far cry from the SVR rates for Pegasys or PEG-Intron. It had a phenomenal following, but never made it to big leagues despite its extreme virtue, better tolerability than its competitors, and higher potency. Great drugs do NOT sell themselves, and are NOT automatically destined to greatness.
Karmaswimswami,
Thanks for all the great info. I know this is about cycc, but I’m not a fan. I do own mdfzf, sbotf, and due to your comments, am adding bnikf, if it will just pull back a bit. Any more info on these and / or others you feel have potential would be much appreciated. I usually get burned on biotechs, ex; gern, fold, ect.
Thanks again for your time.
Wow, Intercept Pharmaceuticals (ICPT) is up almost 200 points today at 466.27! On 1/8/2014 it closed at 72.39; on 1/9/2014 it closed at 275.87. Does anybody have this one?
Wish I did. I may get in when they cool down. They are also trialling obeticholate, their NASH drug, for PBC and hepatic fibrosis. It may well work for these. This was a true stealth company that no one knew about! Analysts are quickly revising their ratings to sell because of the huge appreciation. They do have a blockbuster agent on their hands.
No but I do own Rexahn (RNN) which is up about 200% and climbing for 2014.
There are many things to be excited about with CYCC and I won’t be able to cover everything, so do your own research.
From the medical point of view – outstanding survival data as I already detailed above.
Also, the drug is active in both blood cancers and solid tumors. So, it does not matter what class it belongs to, it’s the results that matter and how close to approval the drug is.
Phase 2 RMDS final data just out. Right now the company is in discussion with FDA regarding the registration pathway for MDS. Possible outcomes: accelerated approval, breakthrough designation, fast track designation, Phase 3 trial under SPA.
Phase 3 AML is ongoing, interim results expected later this year.
The company has two shots in just late stage development – RMDS and AML.
Approval in just one of these indications would lead to off-label use in another, like for example happened with decitabine. I am not even going into the earlier stage developments like breast and ovarian cancer.
Biotech companies tend to appreciate the most prior to approval decision, not after it.
At market cap below $100M a cancer biotech in phase 3 trial is a bargain. Approval is not priced in at all. As we get closer to approval, market would increase the chances of approval and the stock will rise.
Comparable stocks have at least $200-$300 market caps.
For example, SNSS which is also in phase 3 AML trial has $250M marketcap and there is no good reason for their market cap to be higher. I was shorting this pig on every spike and partially covering on dips as I believe their drug won’t be approved and am still short some.
Registration plan for MDS is the near term catalyst. Unlike some other companies, the management has been modest and have not been hyping the best possible outcomes, so they are not priced in at all.
Eastern Capital holds 7% of the shares. It is the family of Kenneth Dart, who is a very successful investor in biotech and others.
The downside is limited as the cash position is solid plus “line of credit” from Aspire.
The upside is unlimited.
Some great info coming out here… What we need is a gumshoe in Gumshoe-land to work it all out for us 🙂
Watch SBOTF. I just got a feeling.
They’ve been working on this for a while
Now. I just took a position this week.
Nothing to back it up, but just the feeling.
Harry–hold SBOTF until the end of 2015 and you will not be disappointed. It’s got a tremendous upside and I really don’t see how you lose money on this one (except short term trading). Buy and be patient. It’s trading right now on the lower side of its recent range (although as I type it is up quite a bit today).
I presume that this is the keyhole limpet hemocyanin website:
http://www.klhsite.com/about-klh/
It is an interesting protein, but I am having a hard time seeing what is transformational about it, what aspect of it will catalyze appreciation in shares of Stellar Biotech. It is hardly a new molecule to this industry. It is essentially a reagent, a protein platform to which other proteins can be attached, via abundant lysine residues, for making antibodies. This is many years old. I am having difficulty seeing any evidence that there will be an uptick in need for KLH. Stellar Biotech supplies it, but is not itself a vaccine maker. For more modern vaccines, what is really needed is a better means of presenting antigens to dendritic cells (such as alpha-2-macroglobulin does). KLH has no attributes in this regard. If the SBOTF longs know something I am missing, please share or enlighten. SBOTF has no pipeline at all. It has been many years since any insiders bought any shares.
Karma: they do have their own C. Difficile vaccine in trials now and have a partnership with Amaran (private Chinese biotech) to supply them with KLH. If you look at the many trials using KLH right now by many companies there is def. potential for a large growing demand for KLH if even several of these trials succeed. Stellar is the only company to be able to patent an extraction process for KLH that does not kill the animal and the only company successfully farm raising the animal. Keep digging and I think you will like what you find; if not I’m listening as well. I’ve made money on the stock and love it for now but I want to know all sides of the risk reward equation.
David: They have done preclinical work on a C. diff. vaccine in a mouse model, and they have patented the PSII-KLH conjugate. But I can find no evidence or report that such a vaccine is in clinical development or human trials. Does Stellar have any experience actually conducting trials in humans? I cannot see that they do. And as regards developing a vaccine against Clostridium difficile, that is going to prove mighty tricky. Or I might clarify that and say that devising a vaccine that works will be tricky. One must come up with a way to co-opt the immune system into making secretory IgA, not IgG. It is unclear that IgA elaboration , however, would make much difference in the colon (polio vaccine causes IgA production, but works higher up in the GI tract. C. diff lives down low). Meanwhile, many other companies are much farther along in a race to a C. diff. vaccine. Sanofi started phase III trials for one in October 2013. So what remains is them being just a KLH supplier for other companies. And KLH is of no value for antigen presentation to dendritic cells. It only works for making antibodies, and so may have limited utility in devising antitumor vaccines, which work based on cell-mediated, rather than humoral, immunity.
KarmaSS: I appreciate your answer, but wonder why so many companies seem to be wasting time and money using KLH in cancer tumor trials if it is ineffective? You are correct that most of their revenue will be coming as a supplier of KLH, at least for the time being, but this market looks like it could explode given the many human trials involving KLH that are taking place. Am I missing something?
Where else but on GS could you find such intelligent, productive, informed, reasoned, referenced debate?? Speaking as the person who forwarded/suggested this CYCC tease to GS….(hope thats not too presumptious Travis) I must say Im astonished both by the font of knowledge thats been tapped here and the level of constructive debate (although karmaswimswami’s ‘constipated’ remark Jan 10 7.09 did make me LOL as it proves that when youve got the grey cells, you really dont have to resort to profanities to tell someone what you think they are full of ! ).
As for the science………..I only hope someone will reco a pill that could cure my ignorance? All of you guys really make me feel dim.
Well done all; Its not a dick measuring contest so please continue to work together in harmony so that lesser mortals can profit by standing on the shoulders of giants.
Oh, and karmaswimswami…… can I sign up for your tip sheet please (Im serious)
Think I’d like your tip sheet also swim! ; )
If such a thing exists (Karmaswim tip sheet) I’ll add a fervent “me too!”
This is to all posters:
I can read, and and am intelligent enough to understand. Something I don’t understand is the prolific overuse of acronyms and initials. It seems to me, that those educated in the field of whatever we are discussing, want to show their level of education by using these short cuts.
My career was in advertising and communication, and I ardently advise, if you want to get the message across please adhere to the time honored “KISS PRINCIPAL”…….it means “Keep It Simple Stupid”……..and it works! Try it!
Isn’t KISS an acronym? Yes, youve explained it, but what’s the point of an acronym if it has to be explained everytime until it becomes a part of the language. Surely it’s for those that can’t comprehend to educate themselves….try Googling. You may discover a whole new way to communicate with a younger generation.
karmaswimswami, add me to your tip sheet too!
Harold, I appreciate the compliments of you and others. I love this forum and will keep posting biotech investing ideas and comments here, especially on days when Travis posts an article pertaining to biotech or medicine. I have a close friend, a woman who is an analyst in Australia for a major firm. Any time an interesting biotech company comes along, she dissects its financials, and I suss out its science and medical relevance. I am an MD, PhD, and like to assess both whether the tech is solid and whether it is really likely to have clinical relevance and find favor with doctors. We have thought for a long time about starting a newsletter or blog, and if/when we do, I will mention it here. For the nonce, Travis has provided a great forum.
Both of us concluded months ago that Benitec is a screaming buy. For anybody who might be interested, here is a good, balanced story on it in the recentest issue of the Qantas inflight magazine: http://www.qantas.com.au/infodetail/flying/inTheAir/inflightMagazine/brightIdea.pdf
We are both long on its shares, and for her, it is the first stock she has personally bought for herself in over 10 years (she has been quite the bear on Australian issues). The company’s technology is extraordinarily complex, so much so that even for me, with a molecular biology PhD, I spent a month reading about the details before I had them firmly in grasp. We have spoken with management at length, and have actually learned some very cool ancillary observations from studies of ddRNAsh in animals that haven’t yet made it to publication. They incorporated some of my suggestions into study protocols. We feel that even if the tech does not work on first try, there is no downside for the stock, as its cash flow position from licensing its tech is remarkable. It is trading on the cheap because literally no one seems to know about it. No analyst (except her) is yet officially following it. Before either of us bought shares, I read 200 very hardcore papers about its science and about competing technologies.
It is quite interesting to speculate about what is going to happen in the next few weeks with Benitec, which trades in the US as BNIKF. (Note that the ASX and American shares have no ADR relationship; they are not pegged; they trade as separate pools). My prediction is that the first HCV patients who get TT-034 and have their HCV RNA burden measured by RT-PCR 30 days later will all have decrements. Word will leak, it always does. There are many gradations of success, from bombastic to efficacious-but-needs-tweaking. But if there is any viral drop at all, and there is a 95% chance there will be, in my estimation, I see the stock going crazy. What realistically will happen? Here’s what I think. I think almighty Gilead, which has mortgaged it soul to be the dominant player in HCV (remember, it paid $11 Billion to buy Pharmasset JUST to get sofosbuvir, which hasn’t yet earned a dime) and which by some measures now has negative book value because of all its intangibles (12 company acquisitions since 1999), is going to get very interested. Gilead MUST make scads of money on sofosbuvir and ledipasvir to stay alive! Tiny Benitec is a David that could bring a Goliath to its knees because its approach could well prove to be a one-time, one-dose cure for HCV (and by extension could be used to cure HBV). Companies may go into a bidding war for Benitec, either to embrace and market its tech, or to silence the RNA silencing approach.
Benitec’s biggest American investor is Kevin Buchi, who was given a board seat. Review, if you like, Buchi’s history. He led Cephalon to extreme success and a buyout by Teva. He is known for investing lots of money on the downlow into small biotech companies that no one has ever heard of, and then having those companies flourish and succeed.
So, disruptive, transformational science that could change how medicine is practiced in the near-term, and tech that can in theory be used to treat any disease that is amenable to therapy by silencing DNA or RNA expression; this includes pain, cancer, HIV, amyloidosis, hemophilia, HCV, HBV, other viruses, and arcane problems like storage diseases (ie, ZZ-phenotype alpha-1-antitrypsin deficiency). The closest competitor is Anylam, grossly overpriced, and with frankly inferior methodology. Their approach requires q2weekly injections of very high doses, and there is evidence that responsiveness fades over time. Benitec’s requires a small iv injection every 6-12 months. Can you really afford to sit on the sidelines with this coming along? 2014 will be THE year in which Benitec’s method either succeeds or fails, because it is just now, starting this month, getting its first-ever trials in humans. Who knows… maybe we can even persuade Trader Vic to take a long position.
I assume thats ticker BLT on the aus market. Can’t find a UK ticker. If not I just ordered some shares in a cough syrup factory !
And just so no one thinks what we do is folie-a-deux, the two of us toss out 9 of every 10 companies we review. Recent examples: I think Patrys has some of the coolest anti-cancer science I have ever seen. Anti-GRP78 antibodies. GRP78 is the hottest molecule in oncology right now. She thinks Patrys’s corporate structure and financial position are abyssmal and dangerous. We didn’t invest. She likes a company called GI Dynamics, oddly an American company NOT traded in the US, but traded on the Australian exchange. She thinks that financially they are in a great position and an opportune buy. Their science scares me to death because I predict their endoscopic weight loss treatment is going to be fraught with long-term catastrophes that will get them sued into oblivion. We didn’t buy.
Yes Alan….BLT on the ASX, BNIKF in the US.
Thanks. It was just for some reason my UK tax-free account wouldnt allow the ticker BNIKF. Only certain shares can be bought in a UK Tax-free dealing account and it excludes all OTC/Pinks. But it would allow BLT. (probably because we share a Queen 🙂 Well, if I’m gonna invest in a cure all multi bagger, I want my millions to be tax free !!!
Hello karma, I have done a bit of DD on Benitec and it does look like it could be a good investment. Thanks for the tipoff. However, when I called my broker, MBT Trading, they said they could not purchase the stock, that the marketmakers have control… Suggested I check other brokers. Do you have any suggestions for me. Would appreciate it. WT
Probably a bit off main topic, but……’fraught with long-term catastrophes that will get them sued into oblivion. We didn’t buy.’
Are you entirely sure that was the right decision? You talk about long term probs, but surely you would sold long before then.
Alan, believe me I know what you mean. She and I fought over this one a lot. GI Dynamics has a weight loss system that involves endoscopic attachment of, literally, a very long plastic sleeve in the duodenum (small intestine). I am a hepatologist and gastroenterologist in addition to being a scientist. Their method DOES cause weight loss, a lot of it, by blocking nutrient uptake. And the stock has appreciated. But the method just disturbs me a lot. I have reason to believe it will cause permanent villous atrophy in the GI tract which could affect long term health. There is a huge risk of bad vitamin deficiencies, of bacterial overgrowth, and of diabetes dysregulation. It is a really non-physiologic approach. I just wouldn’t want to be long on something I think has problems, I am more an investor than a trader. I do think there is great merit to investing in things that may have clinical sex appeal. Years ago, I sunk money into a company called Inkine because they were marketing a new colonoscopy prep based on sodium phosphate tablets. I felt it would be a hot fad with no long-term validity, which has been the case. My shares appreciated, no kidding, 1000 per cent in 6 months, and I dumped them and the company faded away. But there is just something that doesn’t feel right to me about GI Dynamics. Some of the places doing the studies are not exactly models of probity. Since I first looked at it, it has begun trading in the US as GIDYL (it is on the ASX as GID). Shares are still cheap, though its market cap is no longer tiny. Prices have been a jagged wild ride. Its clinical data from Dec 2013 were lovely, but there is no long term data. There IS in fact a way to dislodge or detach the sleeve. I keep watching it as an open question, but I like for the intellectual feeling and the “gut” feeling to be congruent before I buy.
“Me too”! I would like to be in the “tip sheet”
I think I understand only 1/2 of what it is said but it is fascinating! Looks like real precise knowledge. I am happy the conversation gets enlarged to other companies than the first talked about. It is useful. And it’s not even out of subject: it’s not petrol!
Plus, David B and Swami -in particular, are very very positive (and not rivaling for anything.)
Many thanks to Gumshoe to make this type of “super live lecture”, possible, and available, free!!! I will buy some of these stocks. Thanks Swami!
Problem for Benite? See the following post and paper:
Post: http://www.sharescene.com/index.php?showtopic=28
Paper Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24390344
John Gilmore: Thanks for posting and providing those links. The recent paper doesn’t pose a problem for Benitec at all, and has been rather irresponsibly misconstrued by bloggers at sharescene, clearly nonscientists and nonphysicians. The Nature paper is a deliberation on AAV8 in mouse vs. human hepatocytes in a xenograft model. It has implications for studies in mice, but not in people or nonhuman primates. Comments about relative lack of efficacy have been taken quite out of context by bloggers. Benitec’s rAAV8 vector HAS already been given to humans and found to transduce hepatocytes with resounding efficacy. What has not yet been given to humans, and will be this month, is that vector with shRNA encoding strands installed, an “armed” AAV, if you will. But that the vector transduces human hepatocytes effectively is now quite established. Also, Benitec gave TT-034 (the rAAV8 plus 3 antiHCV shRNA’s) to cynomolgus monkeys (extreme similarity to human livers) and proved very high levels of production of shRNAs there. It may be more than you wanted to know, but the most elemental problem for Benitec is this: no one knows what the true preferred cellular sanctuary is for HCV in humans. It’s called “hepatitis,” yes, but it loves replicating in lymphocytes and macrophages. I put my biggest concern to the company: if the agent transduces only hepatocytes, how is it going to get rid of an infection in many non-iiver compartments? HCV only infects about 1 of every 10-15 hepatocytes, but abounds in lymphoid tissue. The answers are complex and sophisticated, but I scientifically believe it will work. It would honestly take a 10,000-word disquisition on why, but the data suggests that all those other compartments are in equilibrium with liver. Deplete the liver pool of virus, and all other cell types follow.
BNIKF is literally a penny stock. One of the best ways to lose your money it so follow a self-proclaimed guru into the penny stock market. How do I know that Swami is not to be followed blindly . . because is statement above about saying: “, At best, sapacitabine is extending survival by only 4 months. It cures no one. It has extraordinary toxicity.” What is wrong with this statement:
1) Cycc DOES NOT HAVE EXTRAORDINARY TOXICITY. There is no basis for this statement and the author will not be able to provide one. It is just the opposite. It has tolerated very well by the elderly population most likely to need its drug.
2) Extension of life by four months is only the mean. Some lives have been extended far more than four months by the drug. Regardless, a four month extension is a very big deal for those who are dying and their families.
My point is this . . . this guy talks like he knows what he is talking about. But he makes ridiculous statements . . If you are going to buy into a “penny stock” like BNIKF, be careful . . . very careful. Good chance while you are buying, the promoters will be selling. With little liquidity, it would take much to move the stock a significant percentage. Don’t fall prey to the charlatans out there. Anybody can pretend to be anybody they want on a message board. And when they talk with “authority”, unless you really do your research, you may believe the person knows what they are talking about. Swami has clearly no credibility based on his statements about CYCC. Be careful and do your homework.
Whoah!! There are a zillion biotec/medic companies….this isnt a two horse race. Not meaning to put you down coz I can’t spell half the words you two guys use. But its pos….just pos, theres a short term profit in both. Isnt it possible you’re both right to some extent?
Truthseeker, even though you are a scurrilous carbuncle of a heckler, I do enjoy your rants because they make me burst open with laughter. Such rabid fixity of purpose! Thank you for the mirth. You are neither a seeker nor after the truth. You are vexed with all the anile priggishness of someone who has lots of nits to pick.
Let me just spell it out for you again. I will make it really simple. Sapacitabine is only being examined as salvage chemotherapy for elderly AML patients who are NOT candidates for induction. It will not revolutionize anything because it is only being used to temporize people who cannot withstand induction for cure. If it were not highly toxic, it would not have any role as chemotherapy. It affects replication of ALL cells, and has serious dose-limiting myelosuppression. Its benefit, if any, on AML survival has not been proven at all! The phase II study utilized only historical controls. It will take a randomized trial, the SEAMLESS trial now underway, in which sapacitabine plus decitabine is compared with decitabine alone, to confirm that the agent confers survival benefit. You seem to greatly cathect the 4-month issue. Perhaps someone important to you has AML and is ill. I am sorry if that is the case.
I have never been called a charlatan by anybody but you, and am neither self-proclaimed nor a guru. You either need to adjust your attitude, as this is a civilized forum in which gentlemen and ladies earnestly discuss investment ideas, or else maybe we can have a Thorazine salt lick airdropped in your yard to make you into a gentleman.
karmaswimswami, very good comment about truthseeker, it was about time someone told him off. Thank You for doing so.
Right, tell me off so you hear only what you want to hear. Swami claims to have an MD and a PH.D., so that makes him an expert on everything out there, including Penny Stocks. Follow his advice and be rich.
‘Truthseeker, even though you are a scurrilous carbuncle of a heckler, I do enjoy your rants because they make me burst open with laughter. Such rabid fixity of purpose! Thank you for the mirth. You are neither a seeker nor after the truth. You are vexed with all the anile priggishness of someone who has lots of nits to pick.”
Thanks for your kind words. So, did you find a source yet for stating Sap is highly toxic? Or are you backtracking and simply asserting that all “chemos” are highly toxic?
LOL. And we know he is not a Charlatan because he tells us he’s not. Wow, I feel better about his advice now.
This is getting very silly. Lets stick to facts and leave the personal insults on yahoo! BB’s
I don’t know when I have so enjoyed the finerys of the use of the queens
speech. Also you stretch the limits of my understanding of bio-tech. I have been
fearful of investing in same because of uncertainty of Obamacare. U.S. catch
cold,world get pneumonia? even tho law is not what congress passed or
Supremes ruled on, it looks to adversely affect chance for profit. You lighten
my aged existence, please keep it up.
This is a great thread….thanks to all…especially karma swim swami….
Thanks NIck. I appreciate it.
David B., thanks for the update. I am studying the companies you mentioned.
I definitely don’t want to subvert this into being a Benitec forum, but for anybody put off by the low price (about 0.65 for BNIKF), you just need to understand the capital structure of Australian companies. This is the norm. Study 15 or 20 issues on the Australian Life Sciences index and you will see what I mean. Extremely high numbers of shares at low valuation. It is a difference in fiscal culture. There is a general move in Oz way from such a structure as they now realize it is offputting to investors elsewhere. “Penny stock” has no negative connotation there.
Intercept has gotten a massive haircut today, and may become of interest again to people here. I must say that in light of obeticholic acid, which will be a blockbuster, and the likelihood that agent will get other liver indications, at some point this company is going to look very appealing again despite its recent extreme run-up. We now need to see some quick follow-through between the company and the FDA…..breakthrough designation? Orphan drug designation? SPA? They need to get it to market. No news yet on this front.
TAPImmune T P I V already has a cure for all types. of cancers. s!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Go to their website to verify.
They are just waiting while they negotiate a contract with a drug company.
Great news !!!….If thats cancer off the list, where is my packet of Marlboro 🙂
They sound like so many other vaccine delivery platform companies, but don’t underestimate the sector. Cancer vaccines (and many others) have failed due to poor delivery. The antigens are known but the resulting immune stimulation is poor. Hence the burgeoning number of platform companies working on all different forms of delivery platforms (viral vectors, plastic beads, electroporation, etc…). Based on our increasing knowledge of immunology, someone will find a radically improved system that will work for a variety of vaccines. The big pharma’s need these companies and will be willing to pay for them (ex Inovio). Personally, I don’t think KLH is the answer.
KLH is sure getting fantastic results by a number of companies in a number of trials. There is a KLH website I encourage our scientists and medical folks to check out. And all of this from a slimy sea creature.
David B: I am still studying KLH. I do see evidence that ligating antigens to it can afford good antigen presentation to the cellular (lymphocytes, macrophages, dendritic cells) immune system and not just potentiated the soluble/humoral immune system. I see that antigen-KLH conjugates are in several trials as therapeutic and antitumor vaccines, but invariably these are at phase I or phase II. The one major phase III study I found, a multicenter trial to delay time to progression of metastatic breast cancer, showed no staristically relevant benefit http://www.ncbi.nlm.nih.gov/pubmed/21572124
This admittedly could owe to the antigen chosen rather than to KLH.
My next concern was the fact that Stellar basically has a lock-up on a natural resource, that they are getting KLH the old fashioned way by extraction. Could a cloner come along and make KLH extraction irrelevant. But the protein is too large, and has too much quaternary structure, to be made in yeast or cultured adherent cells. This is for the nonce, anyway. It may eventually be the case that someone clones a piece of KLH, a relevant business end where most of the antigen ligation and immunogenicity occurs, and is able to mass produce it.
A third concern is this: hemocyanins, hemolymphs, abound in nature. I can see no evidence that KLH is a particularly special one. It is available and has been highly studied. However, competitor molecules do exist. For example, the immunotherapeutic effect of Concholepas concholepas hemocyanin is superior to KLH: http://www.fucited.cl/papers/CCH%20Antitumor%20effect,%20J.%20Urol.%202006.pdf
Concholepas is a gastropod found in Chilean waters. It may not be in as tightly circumscribed a biome as keyhole limpets are. So, while I am definitely not as negative on SBOTF stock as I was yesterday, I still have some doubts and questions.
Thanks for the thorough reply Karma–I’m very interested in your further findings in regards to Stellar. There do seem to be a lot of very intelligent investors and even scientists who are quite excited about Stellar and KLH (Stellar stock surged about 600% in 2013 and had been pretty flat for the three previous years and some big money got in as well). Your points are well taken and I try to watch myself so that I don’t become over exhuberant about any company as that can be to an investor’s detriment. Keep feeding the analysis and science–I love it.
Jack, they have been on a watch list of mine for a while. Please don’t take it personally, but I cannot see putting anything in this company right now. They have not published a paper in 7 years, and are strictly doing preclinical work. I see no evidence that they have any product anywhere even remotely close to marketability. They do not, in fact, have a cure for anything. At best, their methodology has been shown to reduce IL-10 elaboration in response to tumors. This is of minimal clinical relevance. Shutting off Th2 lymphocyte responses is quite a lot different from turning on a Th1 antitumor response. This to me is another Dendreon debacle in the making. Dendreon is dead because Provenge is utter nonsense that does absolutely nothing and in fact may be harmful. I would be happy to debate at length adn in depth the whole field of tumor immunotherapy. Interesting in theory, but still several years away from prime time readiness. This is literally a penny stock, with shares at 1.7 cents, on the wildwest Vancouver exchange. It has been more than 5 years since any insider bought shares. Avoid and sell.
Karmaswimswami …..thank you for sharing so much good information. Regarding Benitec, through your conversation with management, do you have any indication on pricing? What will one dose TT-034 cost?
Terje: No one has any idea about TT-034 pricing. The early indications now are that a course of NS5a and NS5b inhibitor combination therapy for HCV, say, 12 weeks of sofosbuvir plus either BMS’s daclatasvir or ledipasvir (both other agents are Gilead) is going to be priced at about $160,000. The old HCV “benchmark,” taking into account cost of transplant, likelihood of either cirrhosis, cryoglobulinemia and/or nonHodgkin lymphoma, was that HCV therapy was cost-effective if it was less than $225,000. The recenter benchmark is $189,000, taking into account duration of response guided therapy and management of complications (such as anemia requiring transfusions). So, if TT-034 works, all they have to do, as I see it, is beat $160,000. It will be priced of course at what the market will bear. Manufacturing costs are low.
Although I think it is late to get in on Gilead, as it had a massive run-up in 2013, it is interesting to note Gilead’s strategy in all of this. Billions have been spent by many companies to develop HCV NS3/4 proteinase inhibitors. But with the Gilead approach, using a combo of an NS5a and 5b inhibitor, no proteinase inhibitor is necessary. Their combo is pan-genotypic, and basically has a 97% SVR rate regardless of whether a patient is cirrhotic, a relapser, a prior nonresponder, or tx-naive. Gilead’s approach, don’t you see, is not only to cure the disease but to topple other companies. Even so, Gilead is going to have to treat lots of patients in many countries to recoup development costs.
Im showing Intercept as IZM.AX @ 0.0020…….am I looking at the wrong ticker coz purely on price this looks like a disaster.
Alan, it is ICPT, on NASDAQ. Down 19% today on 75% higher than usual volume, mostly selling this am. There were analyst revisions to negative just because of the extreme appreciation at the end of last week. Definitely some irrational exuberance last week in the shares. But, great science they have. I think we need to see what plan they have for getting obeticholate to market. The phase IIb data were so strong there was an early halt to the trial. There were no safety concerns. If the FDA were to hint at approval without a phase III trial, I think it becomes a buy. They rarely do that, but in this case they might given absence of other treatments and absence of evicence of toxicity.
Thanks….I know its a pain, but a ticker is always helpful to stop me buying a Yoghurt factory.
‘But, great science they have.’
You sound like Yoda 🙂
I don’t know when I have so enjoyed the finerys of the use of the queens
speech. Also you stretch the limits of my understanding of bio-tech. I have been
fearful of investing in same because of uncertainty of Obamacare. U.S. catch
cold,world get pneumonia? even tho law is not what congress passed or
Supremes ruled on, it looks to adversely affect chance for profit. You lighten
my aged existence, please keep it up.
Don Coon may have it right about CYTR. I bought it in December and it is already up 33% for me. Down a bit today at $7.47, but maybe going back up like one of those big flying machines?
Graf Zeppelin?
The Zepplins were great airships in their day. Trouble was they depended on gaseous hydrogen (H2) for lift instead of wings like those on a $7.47. I visited the site of the tragedy at Lakehurst, NJ a few years ago. The gigantic Hanger where they were sometimes sheltered is still in operation as a sort of museum. I have sometimes wondered if when trying to land, ,those Zepplins had to release H2 just as they had to release water ballast when trying to rise for takeoff.
I hope this stock doesnt end up in a museum too !! Still now we know who is responsible for global warming 🙂
Ps I know nothing about the company so I will not be investing for 72hrs or more probably till too late….perhaps.
Bought 3 years ago. My broker is high on this stocks. Knows some of the main people. looking great with monster volume. Had to wait a bit but paying off now. this could go to the moon. Stage 2 results were great. We shall see.
I feel the market has priced in eventual FDA approval of aldoxorubicin from CYTR for soft-tissue sarcoma as either a first-line or second-line agent. There will be a long lag before there is a new catalyst for appreciation from agents in its pipeline, though they are appealing. I was in and then out of CYTR years ago, and made money. It has certainly been one jagged ride for this stock over the years. I would say hold but not buy.
I am the guilty party Karma and I agree with your assessment.
Whoever started the discussion about Rexahn: I have to say it looks pretty doggone auspicious right now! In preclinical studies, its anti-P68 RNA helicase agent supinoxin looks very good, and it completing enrollment in a phase 1 trial. In oncology, all phase I trials have phase II ramifications as those trials are done, of course, in cancer patients. Phase I looks for tox, phase II for proof of conceptual efficacy. Of all the companies others have mentioned here, Rexahn appeals to me most at present, and I will be reading up further on it. It has a nucleoside analog in development, but supinoxin would be the reason to invest. Very cool. I’m not a buyer yet, but my interest is definitely piqued. Novel agent, novel class of agent, first-in-class agent, looks very interesting, and would have applicability in a very broad range of cancers.
Many thanks for your comments, Karmi. T bought a bit of RNN this morning so it promptly dropped a little and I may buy some more. The candlestick chart shows a couple of gaps up and the P&F chart shows a bullish penetration of a downtrend that began around $9.5 in May, 2008. It is now consolidating around $1.33.
Last week I bought some small positions in 6life science outfits ATHX, CIGX, DRIO, PSTI, NEO and NBS. Any thoughts on any of these?
Robert: Still looking over those companies. Sorry, but I don’t think CIGX is a valid symbol. I have known about Athersys for a while. Clever company, and perhaps less speculative than the others, I think. Still studying.
What’s with the RNN major sell-off today? Is it a buy-on-the-rumor-sell-on-the-news effect? They announced plans for a new clinical trial. The more I look at them, the more I like them. Seems that their higher prices of yore had to do with a depression drug and an ED drug that they divested themselves of for lack of efficacy. They are now an oncology player. We will be hearing more about them, I think. Excellent cash position to keep its trials going.
It is probably a selloff for RNN today due to its steep recent price rise; however, there is news– it was granted “Orphan Drug Designation” today for renal cell carcinoma. Maybe orphan drugs aren’t as profitable as others? But the chart still looks OK — P&F chart down 3 boxes, seems just a normal correction (so far).
Heres a link to what RNN is doing attached to Form 8K: http://archive.fast-edgar.com//20140114/AI2ZKQ2CZ2224ZK222232Z32PUMRZC22DW62/
As for CIGX, sorry I goofed!! It should be CGIX! It is also down three P&F boxes today.
I had put in a buy order for Benitec as BINKF but it hasn’t been filled. Maybe it’s up too much. I may try to buy it in Australia as BLT.AX.
Orphan Drug Designation is good thing and increases profits due to cheaper trials.
From the FDA site:
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.
Robert: it’s BNIKF, not BINKF. That’s probably why it isn’t going through.
Orphan drug status is excellent. It has been rumored for a while for that agent. I think people are just selling on the news that it has been granted. The rumor was the etiology of the run-up. RNN is looking might attractive now with its pullback!
Thanks for the info on Orphan drugs, George and Karmi. Glad to know it may be a good thing, even if some guys maybe are shorting it.
As for my goof with BNKIF vs BNIKF, there I go again! Transposition is now elgible for becoming my second middle name.
I’ll be 90 in a couple months, and then maybe I could proffer some advice on how to stay mentally active while sometimes losing a little money on the market but gaining through these communications with active brains like yours’.
If only my rusty hip-hinges would pay attention while I’m sitting here looking at 0.09 miles registering today on my trusty pedometer! But a rainy day like today’s keeps me seated here rusting away instead of getting some healthy exercise walking down the street with my wife! Tomorrow is looking better.
Karmi, I’ve been reading all these comments with gret interest, and particularly yours today to James Franklin. It shows a remarkable feeling of senstivity for your patients — I wish all doctors were as concerned as you!
I have been cleaning up a portfolio and have redeployed some cash from the proceeds and tken some more small positions in these biomeds: SRPT, IDRA, CHTP, MNKD, NPSP, SGMO, ITUN, NVAX, CTIX, GALE, TKMR, RXII, NVAX, INO, ICCC, GNVC
i WAS CUT OFF SOMEHOW, also bought PSXP, CLIR, ABTL, CBI, CBK, CPLP, CHTP, MNKD, NPSP, ITMN, SGMO, NVAX, CTIX. Have you ever heard of any of these? Their charts are all of these? Their charts are all bullish at this time.
Yes KSwamSwim: RNN has a very strong pipeline for a small company. I think the sell off today was either profit taking or some fear of the big recent run. I expect this company to be up to at least $3 per share by year’s end.
RNN management did an biotech convention presentation the other to which I was able to listen to. I had already bought a small position, and based on the presentation, I bought more.
I was the one who mentioned Rexahn and yes it’s got an awesome pipeline for a small company. I have to give credit to an author who goes by Long Term Bio on another site for tipping me off to this very promising company. He also likes RXII, CTIX and INO, but I think RNN is the best of this lot personally.
Oops, I am clicklexic apparently, keep commenting on the wrong comment. I was the one who mentionec Rexahn and agree with your summary above. An author named Long Term Bio wrote an excellent summary on SA and that’s when I bought. It has a great pipeline for such a small company–great upside potential.
William Tweedie: Sorry, don’t know what the problem is with your broker and BNIKF shares. It is an OTC stock in the US, so I don’t think there is a market maker. I bought via e-trade many months ago and had no problem. I would ask again and be sure they weren’t trying to buy BLT shares on the ASX.
Thank you Karma. I’m trying to resolve the issue. Probably will have to change brokers…pain in the gluteus maximus!
To anybody interested, Benitec e-mailed late last night. They had just gotten an e-mail from the FDA giving the go code for the TT-034 trial to begin. I never doubted the FDA would approve it. I had seen the NDA, and it was superb science. But it is nice to know that for sure now the trial will begin, the first ever trial of ddRNAi in humans, and a transformative event for medicine. They should be putting out a press release at any time.
Couldnt risk waiting for Aus open so had to buy on US while still open….pity