Why Regado May be Oversold
by DrKSSMDPhD | July 27, 2014 10:47 am
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Source URL: https://www.stockgumshoe.com/2014/07/microblog-why-regado-may-be-oversold/
Dr. KSS,
could I ask you for an enourmous favour?
My son was in hospital for an appendectomy last month? Lots of complications …..in hospital for 16 days.
He has since had much pain ….had lots of scans and tests …and they are thinking they should take his gallbladder out.
If I had junior write you a summary of all the going-ons ….would you have a chance to look at it? I know this is asking much, but our confidence in the local ‘experts’ is at a low. I couldn’t imagine anyone we would rather have an opinion from than you.
I could send it to your hotmail account.
Sure, Terje, no problem. I would be happy to help. Did he perf his appendix? He may be left with fibrous adhesions as a result of that, and patients with that often are left with pain, intermittent small bowel obstructions. I would be cautious about going next to cholecystectomy in a male, but let me have a look at what is known about him. Sorry to hear he is suffering.
You are just so awesome! As someone said here earlier ….you are the doctor we all wished we had! Please consider relocating to Arizona!
I’ll have him sit down tonight and put it on paper.
Agree with Dr. KSS assessment. Include information from CT, if any abscess or percutaneous drain of abscess.
Up tonight from Kent Sepkowitz. Really a nice guy and good doctor. I wish I could popularize liver and gut disease as he does infectious disease, but ID always catches the imagination. It will be nice to see what an American tertiary ICU Whole Nine Yards can do against Ebola. I have seen medical practice up close in east African hospitals, and it is worse in west Africa. It may be deadly because of absent mgmt know-how.
http://www.thedailybeast.com/articles/2014/08/01/emory-will-wage-high-tech-war-on-ebola.html
I’ve been to the JFK hospital in Monrovia, and at the time, before the long civil unrest, you had to buy your supplies from a pharmacy and bring them to the hospital before they would do the surgery. At the time many of the staff had not been paid for six months. That was the largest government hospital in the capital of Liberia. The fact that these patients are still alive makes me think this is not too hard to treat in a modern hospital. Gram negative sepsis can take down, kill, a healthy person in our country in a day or two. Interesting mention of tamoxifen, but none of TKMR. Lassa Fever in the same are also had a similar high mortality rate, but locals seemed to have much lower mortality related to immunity. Probably a vaccine would do much to treat this and be better money spent by the military for possible bioterrorism.
Hello Fellow Gummies,
Please allow me to digress from our machinations about stocks for one message to thank Dr. KSS for rendering what is to me nothing short of a miracle.
For years, countless doctors have given me countless medicines and numerous therapies and platitudes about the importance of sleep, in a pathetic and fruitless effort to cure my agonizingly intolerable insomnia.
I have had cognitive behavior therapy, hypnosis, ambien, CPAP therapy, Melatonin agonists, all to no avail.
I won’t go into all of the details, but suffice it to say that I would sleep four to six hours a night, going through the days like a worn-out zombi, falling asleep in meetings, dragging around like an unwatered plant, and just plain feeling rotten all of the time. I was actually strongly considering retirement, simply because I couldn’t handle being so tired so often.
And then, this guy, this doctor whose hand I have never shaken, a man to whom I have never paid one red cent, a man who doesn’t know me from Adam, digs into his thousands of hours of experience and wisdom and knowledge, and tells me to ask my doc for Trazodone, a cheap, safe, sedative known for its sleep maintenance capacities and its support of normal sleep architecture
I am now sleeping seven and a half hours a night; I am never, that’s right, never tired during the day, and only start feeling tired at bed-time. I am awake, alert , and haven’t felt consistently so blessed good in years.
Every morning I awaken feeling rested and ready for the day, and my first thought is “Thank you KSS, the nicest, kindest, most wonderful man I’ve never met.
And for as long as I live, I will say this every morning, and if the Universe is at all ever fair and just and true, then it will give KSS his deepest and fondest wishes, whatever they may be.
Thanks Doc KSS for giving me my life back.
Don Barrett
Doc – I would think that one story like this should cancel out all of the missiles tossed at you. And keep in mind that Don is but one of numerous people that you have helped here.
Thanks for sharing that personal story Don.
Great news! Probably what I should look into. I have sleep apnea and was given Nuvigil, but broke out in rash all over my face for several days. I quit as doctor advised about Steven Johnson’s syndrome, a small chance of this skin eating disease. Don, is okay if i ask, you asked your sleep doctor for this or did your primary care doctor prescribe it?
Your not obligated to answer….just thought I may go that route myself.
Dr KSS, thanks for your help of this to Don and it may help me as well. GOD Bless
You many times Friend.
Very happy to answer Dave; it’s the least I can do.
I went to my sleep doctor and made a good non-defensive pitch like, “Trazodone is a drug that doesn’t impact sleep architecture in a negative way like the Z drugs do; the best part is that I can already fall asleep but it might really help me maintain sleep which is what it is known for.”
Once they knew that I knew what I was talking about (thanks to KSS), I got it.
I was expecting a typical raft of BS about why they didn’t want to do it, but they said, “Trazodone, we use it all the time; you want Trazodone, you got it.”
I take 100MG per night and that does it for me. The best part is, as I understand it, you can take 50, 100 or 200 MG and it is safe.
It’s an old anti-depressant, but isn’t used much for that anymore, and when it was used for that, the doses were quite a bit higher.
Good luck.
The only rare side effect of concern, (one in 6000 men) was aledged Priapism. My doc told me that the manufacturer almost blew their whole budget trying to replicate it so they could compete with Viagra, but they just couldn’t reliably replicate it. I told her that at 62, I should be so lucky!!
Good luck Dave.
Don
Don Barrett: Thanks Don for all the good details. And those wise words. You know I would feel sleepy at work and brain fog. Using the weekend to catch up on lost sleep is not fixing the problem. Glad the medication is making a clear difference for you. Thanks, I will check it out.
Your strength is in how you explain things, Doc KSS. And yes, you make liver and gut disease sexy!!
May I ask, why would one avoid galbladder removal in a male? Just curious. BTW, I am female and have had my gallbladder removed.
Standberry’s Investment Advisory recommended DRTX after the close with a $16 limit and a $26 implied target. Watch what happens Monday!
Should be interesting — I’d guess SIA has a couple hundred thousand subscribers these days.
Wow Travis, SIA is approaching the number of SG subscribers.
LOL – but that’s true only because SIA has been moving backwards at warp speed for the past few years.
With reference to Dr. KSS DRTX discussion at Post 110 above and John’s Stansberry pump noted in Post 125, the anticipated August 6th FDA decision on Oritavancin from MDCO could not be better timed – considering the following:
“CHICAGO, July 31, 2014 (GLOBE NEWSWIRE) — Durata Therapeutics, Inc. (Nasdaq:DRTX) has scheduled its quarterly conference call for Thursday, August 7 at 8:30 a.m. Eastern Time to discuss second quarter 2014 financial results.
The conference call will be available via phone and webcast. To access the call, please dial 866-632-4021 for participants in the U.S. or Canada and 404-991-3968 for international callers (reference Conference ID 79446878). A replay of the call may be accessed through August 22, 2014 by dialing 800-585-8367 for callers in the U.S. and Canada and 404-537-3406 for international callers (reference Conference ID 79446878). The conference call will also be webcast live on the Investor Relations section of the Company’s website at http://www.duratatx.com.”
http://www.nasdaq.com/press-release/durata-therapeutics-to-report-second-quarter-2014-financial-results-on-august-7-2014-20140731-00782#ixzz39CBPRMeV
Even assuming the likelihood that Oritavancin will be approved by the FDA, the August 7th DRTX conference call will provide a great PR opportunity for Durata to promote the comparative advantages of Dalvance (vs. Oritavancin and other treatment options) and to provide an update on the product roll-out. This dovetails nicely with the announcement earlier this week that DRTX has entered into a licensing agreement with Angelini to market Dalvance in 36 countries (mostly in Eastern Europe), with $25M in upfront and milestone payments, as well as ongoing royalties for at least 10 years (as revealed in yesterday’s SEC filing).
Finally, Zack’s is on record as pronouncing DRTX “poised for a (Street) beat this second quarter” – noting that the company received a major boost during the quarter when the FDA approved its antibiotic Dalvance for treating adults suffering from acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, including methicillin resistant staphylococcus aureus.
http://www.zacks.com/stock/news/142160/3-eye-catching-health-care-stocks-this-earnings-season
Doc Kss,Antisense Therapeutics will be reporting data on 1102 for MS soon.I believe they will need a partner if data is good.Wouldn’t maybe Biogen be a ideal partner with the Tysabri extension patent coming off in 2017 or possibly Pfizer who is hungry for good drug prospects.Just speculating here but with good data I believe there will be some major interest.
Cheers,Glenn
New Dr. KSS report just hit the street, and it’s his all-time best article (Non-Statin Pill that Really Lowers Cholesterol, Blood Pressure).
To Don Barrett: Thanks for your kind comments, and I am thrilled the new approach is working. Keep in mind that the degree of benefit at this dose level may wear off after a couple of weeks, and you may need to bump up to 150 mg or 200 mg at night. But you won’t have to keep advancing the dose forever, and the highest I ever have had to go in anyone is 300 mg at night. It is quite safe all the way to 600 mg/day. Many patients who take it find that they have peculiarly restoring sleep….it’s the kind where you go into la-la land, and have cross country road trips there and have epic dreams about major things. They wake up really feeling rested, really feeling that sleep was the transformative, healing experience it used to be when they were teenagers.
To all: medications for male sexual dysfunction are related to erectile problems, not desire. In some cases, when lack of desire is the case, testosterone levels may be now and giving some can alleviate the problem. In females giving hormones doesn’t help. Since there can be many causes of female hyposexual desire I never thought a “female” pill would work so I never considered investing in PTN. Too much of a long shot when many other biotech companies seemed to have a better chance at success. But, the again, who knows?
Peter: bremelanotide is a pro-opiomelancortin receptor agonist that was originally developed as a nasal spray to induce sunless tanning. Men who got it would get two things: spontaneous erections, and high blood pressure. Animals who get it display immediate mating behavior, including lordotic receptive posturing. Given SQ, it doesn’t cause HTN, and it has done quite nicely in phase 2b for overcoming hypoactive sexual desire in women, but not for female sexual arousal disorder. At issue is not efficacy but funding for phase 3. The company doesn’t have it, is making no progress despite many months of strategizing. FSD is often assessed wrongly as depression and of course SRI’s do nothing, and only rarely does testosterone or any sort of hormone intervention make a difference at all. At PTN’s site is a nice pdf of their study data. It works and is in fact accretive in effect with regular use. But when an investment in PTN will come to anything is what is here at issue.
Doc. KSS, Thanks to Microsoft and their “security” apparatus, I’ve been locked out of E-mails for about a fortnight and so have only skimmed above. Your article re Regado was most informative. During my lockout I was thanking the Universe for the price tumble (selfish, I know) as it’s FINALLY got down to a price where I could buy. For Heaven’s sake don’t start with the incipient paranoia…as DMBD said , you just need decent sleep for a few days and to forget about the Gumshoe mob for a while. How on earth do you expect to be at the top of your game if you’re all strung out. I know we all have different levels of coping with stress but, judging by some of your replies, you’ve about reached your limit. TAKE A BREAK!!! Sue.
Dr. KSS,
I’m still holding a small position in RNN. Do you see any light on the horizon even if it’s a long way aways?
Matt: it may have bottomed here, based on the chart. When I bought RNN, I got in it for Supinoxin, the inhibitor of an RNA helicase expressed only in cancers. It seemed then that they were shelving Archexin, which is an antisense. One should use antisense when the goal is dialing back protein expression. For a cancer indication, antisense is worthless. Yet they insist on whizzing away capital chasing Archexin. Meanwhile, they have stuck with only 3 study sites on Supinoxin, and it is taking forever for them to get phase 1 done. I would just look at time horizon and your level of aggressiveness. For me, when I sold it was clearly going lower (it did) and I knew of seemingly better plays. Since then biotech has gone into Ursa Minor mode. I might just sit tight if you are still in it, as a floor is in now.
Ok thank you very much for the info and I have basically the same question regarding Benitec. I had been following the very long comment section which I can’t seem to find anymore but given the spike today 09/02 was curious where you stand with this? Thank you.
Matt see my post#393 on the oxidation thread to find past comments or bookmark this
http://www.stockgumshoe.com/author/dr-kss-md-phd/
Awesome, thanks Frank.
Any ideas on when the RGDO trial might resume or if it will resume? Just someone not usually in the know asking? Thanks for any replies.
FWIW heres my take having read a lot on GS. There were 3 adverse reactions out of 1400. Regardo (sensibly!) decided to stop the trial for investigation rather than let the FDA stop it. Those reactions were in people who have chronic reactions to drugs. My guess is that with a bit of label adjustment, the trail withh soon (1 month?) resume. RGDO will then look v cheap as of todays price.
Also see AMPE today…lost 30% due to the trial drug stock not being stored at the right temperature. Bio is fickle.
I own and am buying RGDO but thats my choice.
Bob: agree totally with Alan.
To just build a little on what he said, this is administration of naked RNA…something the body rarely sees except in viremia (severe virus infections with RNA viruses). Based on the timing of the events, the fact that one of them happened in someone “allergic to steroids” which is impossible, and the fact that for a certain number of people, when you tell them they are getting an investigational agent (even though they’ve consented) they get heebie jeebies upon injection: “I feel short of breath,” “I am tingling” I feel no horror is lurking here. Even if phantom stuff cannot be objectified by examination, it MUST be reported. So as I see it, 3 known adverse events only ONE of which had any veracity (you can’t fake hypotension). I feel the drug is activating complement in a few, and that the company is not trying to decide whether to fold but merely trying to come up with guidelines for who gets steroids and antihistamines before dosing. I could be wrong, “this is biotech” remember, but that’s my read and I am deeply planted in this stock. Timing of resumption? I think we will know within 10 days. If you or anyone else is specifically interested, become this group’s daily eye/ear for the next two weeks about Regado. Check on it and tell us if anything pops up. There’s more to it than Googling “Regado,” as Glenn can attest. Glenn finds amazing stuff because he searches, gets a clue, chases that, gets another clue, chases that and so forth til he has come up with just profound stuff of relevance that mere Googling cannot. I do a good once over on Regado every weekend, but something could pop before the weekend rolls around.
Just saying.. I’m a huge and grateful fan of Dr. KSS articles, but the comments and unfounded projections in this entry are in sharp contrast to the factual and educational material you have presented in your wonderfully informative body of work at SG. Your articles are well worthy of use in academic discussions to educate those of us not in the medical field, but your comments in these comment sections occasionally seem to undermine your credibility by becoming defensive, selectively dismissing evidence, or projecting unsupported assumptions that support a “bull” position in stock buying….. eg “phantom stuff”…
Regado isn’t my first hit, and certainly won’t be my last, and I am typically cautiously invested in these stocks. I just hope that you can do a better job of relying on your excellent .. downright superb… initial reports, and try not to be provoked into less balanced responses in the comment forum to defend your positions when they really need no defense: The articles share facts and your opinion. They are excellent. They are what they are. As opposed to the forums, where all too often things rely more on emotional responses. It’s the emotional venue of the “comment” section that kills the goose.
I am in the construction field, and I am a forensic consultant on building failures and love being a toolbelt detective. When I occasionally have to testify or offer my opinion, and when it is challenged, my response in one way or another is simply: “read the report: it is what it is…, my opinion based on decades of experience with these materials.” I am confident base on the evidence. Anecdotal information is colorful and helpful, but unless supported can simply confuse the issue. It also needs to be clearly defined.
One other question.. you said that allergic reactions to steroids are impossible, so I am curious: I know people who have had strong negative reactions to steroids.. is there another term more appropriate? Thank you, and please keep it coming. Your articles have become a very positive pivot point in both my investing and my broader knowledge of the flabbergastingly complex organism that our body is. (Is that a word? I don’t care.. I liked it!)
I am not sure how to reply. This column was intended as purely speculative, as many had messaged me and asked what I thought. I wrote this to tell them scientifically what I could try to interpolate and infer. I presented no data and did not pretend to. I discussed the science. I openly made guesses and did not dissimulate that they were guesses. This is not a tip sheet, and I am no one’s portfolio manager. I am unsure how to support anecdotal information because it is mere anecdote. The anecdote is a finite limited idiom. I wrote this literally to give people what they requested. I have not been and won’t be paid for it, but decided to sit down after a long hard week and cobble it together on a Friday night because so many were asking. I didn’t do it to gratify myself, I did it because people asked. I have enthused about this company and its agent because people (MDs, PhDs, and MD PhDs) I know well and respect have been involved in it, and like me, they are devastated and disillusioned totally by what has happened today. I tried to find every reasonable angle here to mull Regado based on analogous drugs and situations and what the immune system is known to do.
Since steroids, by which I here mean glucocorticoids, are lympholytic and anti-chemotactic, since they quench arms of the immune system, being allergic to them, which means an immune-mediated adverse reaction to them, cannot happen. All physicians deal with anxious neurotic patients who bear lists of agents they are “allergic” to because this gives them uniqueness. It is a common issue in practice. But when the most elemental action of a glucocorticoid is silencing the immune system to an overwhelming degree, the immune system cannot react to the drug. Steroids are not allergenic.
Rare people have adverse reactions to steroids, which can include neuropsychiatric symptoms. Steroids can raise glucose, boost blood pressure, cause food cravings, and cause yeast infections of the vagina, mouth and esophagus.
Nothing I write here is a solicitation to buy or sell a stock. I am happy to clue people into how I think and what steps I am taking. Every person in medicine and in biological science is accustomed to being wrong a sizable percentage of the time. Lab experiments tease things into single variables, but intact whole organisms, with redundant and overlapping systems, poorly understood feedback loops, and functioning as they do in several simultaneous circles of mechanisms of varying degrees of evolutionary age (the body has at least 7 classes of proteinase, as nature has reinvented the proteinase many times) will never be totally predictable….at least not for another century.
I feel that the best attitude one can have about biotech is rational-positive enthusiasm. Which is me. Great study results or bad, I am happy to be in it. I don’t mind losing money now and again, as each loss sharpens my game and gives me new tools with which to evaluate the next companies to emerge.
I appreciate your readership.
I think both the questions AND the answers are more than fair. Thank you both. Its certainly been an education.
If I recall correctly, their initial announcement at the time of the hold (July 2nd? or was it July 3rd) mentioned a timeline of 8 weeks. If they are still intending to stick to that timeline, then 8 weeks would be next Wed. (or Thurs.).
Yes, you are right. Good point.
Appreciate the replies very much!
No problem. When Alan, our CEO, deigns to personally reply, consider yourself having had the VIP treatment.
The risky business of investing in biotech has raised its ugly head. It is what it is so move on to the next don’t look back but try to learn something from it!