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 would say it is fair if Brian wants to hire the good Dr at $500 an hour for stock research? Brian, please narrow your list to something reasonable (i.e. your top 3 maybe) as Dr. KSS is doing this out of the kindness of his own heart and the passion he exhumes for the subject should not be taken advantage of IMO! Thanks for your understanding.
To Lou L: You asked some good questions about Revance and about Kindred. I knew something of them from their recent IPO’s as well. A few thoughts.
First, what Revance is trying to do is promulgate a botox formulation that does not require injection. See anything fishy about that? I do.
How does botox work? It works by blunting acetylcholine release at muscles, such that those muscles do not respond to neural signals for them to contract. That’s what botulinum poisoning, such as from failing to boil broccoli for at least a solid 5 minutes is so deadly. It makes you unable to breath because the muscles needed do not respond.
So, botox does not, cannot, work unless it gets to muscle. For this protein to reach muscle from application to the skin as Revance claims seems to me farfetched. It would have to go through th stratum corneum layer, on down through the dermis and subdermal matrix and into muscle. They are advancing it for canthal lines, crow’s feet. They claim the botox gets there by something tantamount to magic: that they add to it a trick peptide that causes skin cells to pinocytose it, ie, drink it up, and then transcytose it, ie, spit it out their other sides. This isn’t how squamous cells in skin behave and it would be difficult to persuade me that their product is doing what they claim it does. For sake of full disclosure, I am long Allergan (AGN) and have been for several years. AGN really owns botox intellectual property. I notice that Revance is doing its phase III outside the US. Is that because of a rights issue, a licensing problem?
A second concern I have is how this will fare with dermatologist and plastic surgeons if it is approved. Botox products fro cosmetic indications are never covered by third party payers. Revance’s main product is proposed to be in patch form rather than injectable. I question whether doctors will steer patients to it because they stand to make more from injecting botox in their offices and billing for that. So I have doubts about approvability, about scientific authenticity, and about whether the product will catch on if approved. I might consider cashing out if you are in the black post IPO.
Kindred is a tough read. I am not finding publications about its products or links to studies. The way in which this is done for veterinary medicine is probably without the hoopla and fixity of purpose seen for human drug studies. So I just don’t know. If you can steer me to data, I would be happy to review it, but their website seems nearly a stub. Certainly as regards dogs and cats, one cannot infer that human drugs will be safe or effective in them at all. The biology is distinct. KIN does seem to be pursuing targets like Bruton’s kinase known to be of special relevance in dogs.
Dr karma, Thanks for your insightful comments on RVNC. It’s very helpful. Will close it after flipping period is over. After all, I rode DNDN from 7 to the top (50+), only to close it later at 5. If only I knew you then.
KIN’s strategy is to develop therapeutics for animal based on the ones successful in human. The development cost should be lower than that from human and the bar for FDA may be lower as well.
SA had a good review of KIN here,
http://seekingalpha.com/article/1941441-baupost-group-acquires-huge-stake-in-kindred-biosciences
Dr. KSS, re: # 419….. you said “A number can be x times greater than predicted. It cannot be x times less than predicted for x greater than or equal to 1.”
I have to respectfully disagree… “20 times less” = 1/20. If you expect 100% and the result is 5% then the result is 20 times less than expected. If Dr. Kay was expecting close to 100% expression of factor IX then 20 times less is 5%. Since patients ended up with 2% – 11% of normal factor IX, his statement makes sense to me.
You make some good points as to the unknowns regarding chimeric livers. I have no doubt that TT-034 will show a response however if the response is similar to the hemophilia factor IX results, another AAV will have to be tried and wouldn’t that raise the odds of a T-cell immune response that will limit efficacy?
TO ALL This is example of what gives me vertigo in some exchanges. If I have $1. & it multiplies 20 times I have $20 .I cannot lose that $1.00 20 times; just once & I have 0 dollar. Think this is like difference of philosopher & engineer. Say is object of sexual desire across room, you can jump halfway per jump. Philosopher says never reach desire. Engineer says 10 0r 12 jumps close enough for “working distance”
Lest I leave crude impression I only mean tender touch.
Frank, 100% agree.
100% more = 1 time more
50% less = 0.5 time less, not 2 times less
To the optimist, the glass is half-full. To the pessimist, the glass is half- empty. To the engineer, the glass is twice(2 times) as big as it needs to be.
Dr KSS, Here are some details on what you asked on PTN
Nature abstract here:
http://www.nature.com/ijir/journal/v16/n2/full/3901200a.html
From their website:
Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
In the Phase 2B trial, bremelanotide showed a statistically significant increase in the number of satisfying sexual events (SSEs) versus placebo (mean increase in SSEs of 0.8 (2.9) for 1.75 mg (p = 0.0215) and 0.7 (2.4) for 1.25/1.75 mg pooled (p = 0.0180) versus 0.2 (2.3) for placebo).
Statistically significant or clinically significant trends versus placebo also were seen in the HSDD and HSDD/FSAD groups:
The mean change in Female Sexual Function Index (FSFI) total score, which measures overall sexual functioning, was 4.4 for 1.75 mg (p = 0.0021) and 3.6 for 1.25 mg and 1.75 mg pooled, versus 1.88 for placebo.
Mean change in Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, or a measure of distress related to sexual dysfunction, was -13.1 for 1.75 mg (p = 0.0005) and -11.1 for 1.25 mg and 1.75 mg pooled, versus -6.8 for placebo.
Palatin Technologies has extensive clinical experience with bremelanotide. Over 2,000 patients have received bremelanotide in 30 clinical studies with either intranasal or subcutaneous formulations, with demonstrated efficacy for both FSD and erectile dysfunction.
Regarding patents, here is what I found from lifesci report
Bremelanotide is covered by substance patents issued in the US, 18 European countries, Japan,
Mexico, Korea, Australia, New Zealand, Brazil, and Canada. The US patents will expire in 2020
before any extension under the Hatch-Waxman Amendments (five year extension anticipated).
Palatin also owns a US patent for an alternative class of melanocortin receptor-specific peptides, and
has pending patent applications in the US and several foreign countries. The expiration term for the
patent is 2029. Patent applications are pending for a second class of melanocortin receptor-specific
peptides, and if issued, would expire in 2030.
Here are the patents:
http://www.google.com/patents/US6794489
http://www.google.com/patents/US6579968
http://www.pharmcast.com/Patents/Yr2003/Jun2003/061703/6579968_Sexual061703.htm
The entire report from lifesci is here for everyone.
http://www.lifesciadvisors.com/clientinfo/palatin/Palatin__LSA_Initiation_Report_1-8-14__clientinfo.pdf
Does anyone know if the wonder teen Jack Andraka is linked to any company at this point? He’s now 17 and when 15 did some pretty incredible work on pancreatic cancer.
Steve and others #449. Doesnt that CHTP crash in mid jan give you cause for concern?
Sure does. Caution! While I know very little of options, any purchase of CHTP shares or calls this week would need to include parachutes, i.e., puts, such as the Feb or March $3 puts. Despite the FDA advisory board 16-1 vote to approve droxidopa/Northera based on CHTP’s 306B study, there are concerns here.
1) I asked Dr. KSS, above in comment to #449, whether the resubmission satisfied the FDA’s request for “long term” efficacy of “just a few weeks.” To me it appears it did not. Thus, the FDA would be justified in going against the Advisory board.
2) The FDA could postpone its decision for 3-months for such long term efficacy data, which will likely drive the pps down. If you are holding a Feb option or wanted a short term gain this week, this is the equivalent of the roulette ball landing on green/zero, when your bet was on black or red. I invite the option experts on our board to suggest a winning straddle asap, if one is still possible.
upcoming conference information!
http://www.bio.org/sites/default/files/email/CEO2014/CEO2014_EBrochure_FIN.pdf
Lonesome doc #443 (yours only just come thru so you hid that well!) What was the last thing that came out of Pandora’s box? Glad youve found it for $49pa….best advice yourll ever buy IMO
Looking fwd to your input here.!!
Alan.
Agree, would have paid more
Siva- Palatin….PTN….If you invest in biotech, you have to keep an eye on Adam Feuerstein who works for The Street, Cramer’s company. I believe he doesn’t have formal, high credentialed biotech PhD or other , BUT he has a very good command of the goings on in the business. He is actively on Twitter, has a blog,etc. If you want to see his affect, look at a PVCT chart a couple of weeks ago and he single handedly dropped the price at 10:30 AM, Jan 23rd from $6 to $2 in moments with a quick story on The Street’s site. On the link above, he doesn’t have a good take on PTN. Take it for what it’s worth. I do have to feel the placebo component of the study in question is potentially greater than what are considered presidence in other non related studies.
http://www.thestreet.com/story/11932328/2/biotech-stock-mailbag-amarin-mannkind-palatin.html
link below, sorry.
All: Admedus will pop here tomorrow morning (AMEUF). It is an Australian company whose Cardiocel method for closing cardiac septal defects was approved for use in the US during the weekend. It trades as AHZ in Sydney.
Bit short notice KSS….but thanks
ask price on Etrade .17 I put my order in. Hope it goes up on this news, but regardless, looks like a good company. Not that I know that much in this area but I am learning so much from this group. Thank you Dr. KSS.
I was too late for the pop, wondering if this is still worth getting into. Up 30%+ today, but the price is still tiny, is this likely to be a short-term pop or is Cardiocel (which appears to be their only product right now) something that’s likely to prove valuable in the long run?
Steve: At this point I will be transfixed this week by the Chelsea saga, A little while ago I made a veeeery strong pot of Earl Grey and read the entire 200 pages or so of FDA deliberations about droxidopa. Just so we are all in the same place, this is a drug that is converted both in the brain and in the body to norepinephrine. The drug has been studied for orthostatic hypotension,(OSH) an uncommon problem that causes dizziness and syncope upon rising too quickly. OSH has several potential causes and in any patient with it, it is key to try to nail down the cause, be it Parkinsonism, enzyme deficiency, primary neurologic origins, etc. Right now the main drugs used for this are either fludrocortisone, which causes the body to hold on to sodium and thus water, and midodrine, a mild vasoconstrictor.
In the body, norepinephrine, which droxidopa is converted to, is mostly a vasoconstrictor. In the brain, however, it stimulates alpha adrenergic receptors that actually cause vasodilatation and also may act to turn off adrenal gland production of epinephrine and norepinephrine.
The studies Chelsea did have quite a few problems. One is that the patients in them are, out of necessity because OSH is rare, very heterogeneous. Droxidopa seems to work well in only a minority. A second major concern is that the studies relied heavily on improvement in a questionnaire about symptoms, and the FDA feels this is weak data, that correlation between the questionnaire results and actual physical symptoms is dodgy. (I feel the questionnaire is dubious and full of placebo artefact.) A major concern the FDA has is about droxidopa causing serious hypertension, which it is quite capable of. For the study, Chelsea measure supine blood pressures with the patients having their heads at 30 degrees elevation, not flat. For most of us, that would make no difference. For OSH patients it makes a huge difference and measuring BP as they did could mask serious drug-induced hypertension. Finally, there is a rare process called neuroleptic malignant syndrome (NMS). NMS is most often triggered, albeit rarely, by certain antipsychotic drugs. When it happens it is life threatening, ICU stuff, with very unstable blood pressure and delirium. Death is common and there is no good way to manage it except managing the patient while the offending drug wears off. Droxidopa is approved in Japan for OSH. But the FDA is concerned about 28 cases of NMS seen in Japan blamed on the drug.
The first time the FDA reviewed droxidopa, the vote was quite mixed but favored disapproval. The second time it was 16 to 1, though the opponent was very credible and respected. How often does the FDA follow the advice of these committees? About 75 per cent of the time. They follow it almost always when the committee recommends against, though there have been a couple of jawdropping exceptions.
This one is risky. One of the most damning things about droxidopa is that it appears that tachyphylaxis (the point where the drugs effects have worn off and require being off it for a while for the benefit to recur) may set in after just a week. The drug appears to shine for only about 15 per cent of OSH patients, but predicting which is impossible. I say there is a 65 per cent (only) chance the FDA will approve it, but if they do it will be with many provisos and the company will be forced to run a phase IV study, which will be costly. So, limited effectiveness across the pool of OSH patients, early onset tachyphylaxis, significant risk of severe hypertension. I personally would vote NOT to approve it. If it is not approved, Chelsea drops like a stone. If it is approved, it will be with so many stipulations that I think the upside for CHTP is rather limited. To me that is just too much trouble for the risk.
One other point I meant to emphasize and did not: 28 NMS cases from this drug is REALLY a lot of cases!
Im betting that the market doesnt like CHTP so has roughly baked in approval ……then it will plummet as in mid Jan. Tempted to short…..not buy
I agree with most of what you just wrote KSS. I do think the drug has at least an 80% chance of approval due to its orphan status, the committee voting 16-1 in favor of approval and the fact that it has some efficacy for a condition that basically has no treatment currently. So we differ a bit on the odds of approval.
I am in for a small position and the stock is up about 7% right now. If it goes up enough in the next couple days, I may hedge my bets and sell off before the announcement : ) So far so good on my short term move as what I sold off to buy Chelsea is moving down today while Chelsea is going up sharply. I totally agree that Chelsea is not a great long term investment and I agree on Earl Grey tea : )
On January 15, 2013, StreetInsider.com stated: Analyst, Wedbush analyst Liana Moussatos, Ph.D. had an $8 CHTP price if FDA approved, and precisely like the eminent Dr. KSS, calculates only a 65% chance of approval:
“With the panel recommending approval, we estimate about a 65% chance of the approval on or by the February 14 th PDUFA deadline…”
http://www.streetinsider.com/Analyst+Comments/Chelsea+Therapeutics+(CHTP)+Has+20-100%25+Net+Upside,+Wedbush+Said/9057320.html
(If buying this risky stock or its call, buying offsetting puts are a must! I bought a few thousand dollars in straddle option positions, i.e., both the Feb $5 calls and $5 puts, with a break-even of a $2 share price move in either direction. The March options would have been less risky.)
CHTP – “Public Citizen”, i.e., Ralph Nader’s 300K member Non-Profit Consumer Advocacy Group’s 2/5/14 scientific Letter to FDA STRONGLY OPPOSING
approval of Droxidopa.
http://www.citizen.org/documents/2182.pdf
http://en.wikipedia.org/wiki/Public_Citizen
There are simple physiological mechanisms to prevent Orthostatic hypotension, like getting up slowly, letting your feet dangle before standing, and the medications above. Truthfully I dodont see a lot of elderly people coming into the ER with this as their sole problem. There may be an infection or cardiac factor in addition to their problem. They usually have multiple med$ that may interact and cause NMS. NEUROLEPTIC MALIGNANT SYNDROME is rare, and if happened much would result in a 1 800-bad-drug call. There still may be a pop on news and speculation, but I’ll miss out. I’m still trying to get options to work for me on blue chip stocks.
Siva: I just want to brood a mite longer on bremelanotide, and cross check a few things that have occurred to me. However, I think you may be really onto something with this one!
Take your time. Thanks for looking into this, Dr KSS.
Thanks for your heads up … Fidelity showed a $50 fee plus $7.95 for this transaction.
Rick (re: post #473), for what it’s worth I have found that Fidelity has that $50 fee for some of the ‘Gray Market / Pink Sheet’ companies that Scottrade does not charge a fee for.
BTW I’m not pushing Scottrade, just suggesting that some brokers charge fees that others don’t. Could be Fidelity is cheaper in some transactions, but I have account with both brokers and check out the other if one wants to charge me a fee beyond the normal $7.95-ish commission.
Thanks. I’ll look into a Scottrade account.
I am quite confused by the Prolieve situation where it concerns Medifocus. Something doesn’t add up. I have been aware of things because I have an unwitting long position in Boston Scientific. I had held shares of Guidant when it was acquired by Boston for a good price plus additional cash and shares of BSX. Boston has always been one schizophrenic company. They bought Guidant when it was in a spat with J&J. They devised a really revolutionary system for endoscopically managing gastroesophageal reflux, called Enteryx. One session and every patient was stopping Prilosec for good. I was one of the first people in the US to be performing it. Then one or two endoscopists of questionable ability doing Enteryx nicked patient aortas, and Boston yanked the method off the market, They devised an endoscopic band ligation kit for esophageal varices that was totally cut-rate in price compared with a competing system by Wilson Cook, but then everybody realized that the Boston system was so shoddy that it took two kits for many of the cases because of device failure. Boston bought Prolieve for $60 million then handed it back to Medifocus for what will amount to $5 million at most. I just don’t know if that was just another schizo move by the wire-monkey management at Boston or if it was reasonable. I have searched for good published trials of Prolieve as to efficacy and complications. They just aren’t there. Something is wrong with this picture.
From the SA article re Medifocus–the Prolieve System is safe and efficacious but the downside of the treatment is that it takes the purchase of the device by the urologist or other Dr. and a somewhat uncomfortable procedure of 45 mts. There is another company working on a shot that can be administered once or twice a year for benign enlarged prostate (the name escapes me right now of this company). That would def. take some of the wind out of the sails of the Prolieve System sales if it is approved, but I think that approval is a couple years off although is looking pretty good for that company per the same author. I will see if I can garner more information from the author who has always been quite helpful and responsive. If memory serves, Prolieve sales about doubled in 2013 and should continue to increase unless something goes wrong. I don’t know why Boston sold it back unless they just wanted to focus on other priorities. Companies make some squirelly decisions from time to time.
Question; How is discussion of Travis & Karma etal. going. I think soon must split thread or be too unwieldy , Perhaps: Bio-science,Invest opportunities ,& irritants such as self & others who enjoy ride as much as advice? I still value all. Could this whole thread so far be kept as reference at minimum? Personal Law of Observation “The action is at the edges”. even outliers may form pattern unseen in data bulk. Even holds true in mobs,forests,space & “Consensus”
All irregulars are welcome to open their own discussion thread by clicking “discussion” at top of page. I’m happy to work with the Doc if he wants to publish something more organized.
Dr. Dees $PVCT CEO:
“What people don’t know is that we have been running numerous tests for the Food and Drug Administration… reproductive tox, modern Ames tests, comet micronuclear assay and the drug continues to perform in these tests like in the trials – its safety is unparalleled.”
William Tweedie: Yahoo is confusing me as it shows PVCT at 4 on the year graph , 1.77 as todays price and reletively stable on the 5 day chart. Never mind others, are YOU suggesting this is still a buy?
Definitely. There is so much going on behind the scenes. First catalyst will be the BTD filing, next the FDA decision, six weeks from that, though a buy-out is strongly possible anywhere along the way. The people at this company are motivated to get the drug out there to save lives; fair financial gain will come but it is secondary.
Its all about judging character when you dont have the personal knowledge…..but given youve been consistant since #3, Ok Im in for 3k. Your call….my risk.
There is a very compassionate aspect to the motivation many of our brave scientists have in pursuing their work that is worth knowing and remembering. The following is from an article in the NY Times: http://tinyurl.com/kvcomuy
Peter Culpepper was pursuing a high-paying career as a corporate accountant in February 1999 when his 5-year-old daughter, Victoria, began to shake uncontrollably after a swim in the public pool near their home in Stamford, Conn. She was rushed to a hospital, where doctors found she had a brain tumor.
Within days, surgeons operated to remove a tumor that was nearly the size of a tennis ball. That was followed by three months of chemotherapy and another three months of radiation, an ordeal that left the girl crying herself to sleep – when she could sleep, her father recalled, because she was nauseated and in pain.
Though Victoria was rid of the cancer, Mr. Culpepper was haunted by her brush with the disease and by the fear that it would recur. Although his career was flourishing – he had recently left his job as a controller for Metromedia Companies in White Plains to join Neptec, a maker of optical-networking components in Jefferson City, Tenn. – he felt that there was a void. He had become active with the Make-a-Wish Foundation and the American Cancer Society, but something was still missing.
Then he heard of a job opening for a chief financial officer at a small company in Knoxville, Tenn., called Provectus Pharmaceuticals, which was developing a cancer drug with the potential to attack tumors without the aid of chemotherapy or radiation treatment. Though the job would pay half of what he was earning, he said he did not hesitate. In February 2004, he became Provectus’s fourth employee, with an equity stake.
“We saw how horrible cancer treatments are,” Mr. Culpepper, 45, said. “We are very much committed as a family. And I wanted to do something to help find a cure.”
In Knoxville, Mr. Culpepper operates out of a small gray clapboard building with Craig Dees, 53, a scientist from the Oak Ridge National Laboratory, who founded Provectus in 2002 with two colleagues. There are no corporate perks – flying is strictly coach, and the partners ask for AAA discounts at hotels.
posts #476,#477 Thank you so much for posting this . Once again an example of what a rarity of a discussion thread this is.
As others have commented, excellent as it is, this thread is getting unwieldy. Its easy enough to disect various themes and start each as a separate thread via the discussion board.
Anyone have any ideas….perhaps we need a management committee.
Alan I agree… If Travis , Karma & Siva( I think previously mentioned for thread) are willing I suggest them as committee. BTW when I use search box on name Alan Harris it does not give info I desire. Perhaps could be modified to give thread & post# of those who post?
I do not mean to imply investment decisions should be governed by emotion. Not likely to get much return IMHO. I give no investment advice…
We have Michael Jorrin, “Doc Gumshoe”, as Travis’ and the site’s medical go to fellow. He is the logical, and would be an impartial, moderator for a separate discussion thread. There are subscribers here who are interested in specific areas of investment, metals and mining, technology, biomed and health, to name a few. Would it be difficult, Travis, to create tabs for each of these as they are identified and enough interest demonstrated? It would make it so much easier to navigate to investment ideas and discussions of interest to individual members/investors. This thread is an obvious testament to the interest in bio-tech and I suggest “Doc” start a separate discussion, if possible, with appropriate sub-tabs, such as New Ideas, Investement Strategies, etc. Thoughts?
Frank #479 and william #480
The facility to ‘search’ is the weakest part of GS, especially across threads. I suspect the software cost is making Travis shy. Still people buy/stay in because of what GS provides. Just look at how many people have apparently gone all Irregular just because of the quality of this thread.
Anyone know a good model that could be used here?
Alan: I have a great model outside of GS, but last heard from folks here, they were unwilling to move out of GS. People were okay if it takes 2 minutes to access this unwieldy page.
I think the point was that people felt a loyalty to GS and moving away just felt al wrong. Is there any way to link to that model via GS ? Perhaps a word with Travis would work that out.
I do not know enough about GS and its capabilities as it seems to be a custom designed system.
Thats why you need to email Travis. Good luck for all our sakes
Alan, I’m not able to see a ‘Reply’ to your comment below and hence replying here :-). I will try but I can see that the facility will probably be available only to paid subscribers of GS.
And? You get what you pay for ! The more that come on board GS if goodies dangled, the better. Travis (ie us) cant survive without some $49 ers.
Re replies: GS limits them so just do what you did….works for us.
I have to second what Alan says. If one doesn’t think the investment knowledge and/or the general knowledge on this thread isn’t worth a $49 ante, maybe this isn’t the place for them. To say nothing about the rest of what GS offers. Just saying….