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>More patients have moved to opiates / narcotics since VIOXX was withdrawn.<
Which, if true, is ridiculous since COX-2 inhibitors are no more effective in relieving pain than traditional NSAIDs. Simply prescribe a generic NSAID and a generic PPI, and one can get all the pain relief of a COX-2 without GI risk.
I wonder if anyone is working on a NSAID/PPI combo pill? Seems like a no-brainer to me.
>The second bill he supports.....good: it is a step forward.<
No it isn't. It is based on pseudoscience. This administration is either a) credulous as an inbred country bumpkin or b)willfully misrepresenting facts.
Although I think Bush himself falls into category a, his advisors fall into category b.
In terms of scientific, medical, and environmental issues of any sort, this administration has consistently made decisions that are antithetical to the common interest.
>Most large EU Investment Managers follow AMEX and not Nasdaq because of Nas's eratic volatility.<
I find that very, very hard to believe.
RPRX
Palindromy,
I will never understand why asoprisnil was terminated. According to the most recent evidence, asoprisnil induces some changes in the endometrium, but nothing that would lead one to suspect cancer.
http://tinyurl.com/24t5wc
Same goes with mifepristone: although I don't have the link handy right now, the studies done with mifepristone have not shown pathological changes in the endometrium consistent with endometrial dysplasia with atypia.
In short, the evidence that we have so far for Proellex, together with evidence from other agents that act in a similar manner, suggest that we won't see pathological changes in the endometrium.
Nothing is for sure, but I am reasonably confident that Proellex is quite safe. Together with perhaps the most remarkable efficacy results I've ever seen, there's no reason RPRX should be sitting at $10.91. As far as biotechs go, I view RPRX as a lower-risk bet in the context of the sector but again there's the caveat that all biotechs are risky.
>Coleman-Isakson endorses research upon naturally dead embryos, even though the hope of producing a living cell line from dead cells, is speculative at best and ethically questionable. [I’m not sure I follow the second part of the argument here.]<
Are they talking about Frankencells?
Shears--RPRX
Now that I have a moment, replies below in italics...I'm away from my data on my office computer, so replying from memory.
Is there any data on male bone density effects of Androxal?
It seems to me that the most detrimental effect of male hypogodasim in older males is the devastating consequences on bone health rather than the desire to restore virility.
Perhaps when I am an older male I will look at it differently?
To be honest, I don't even think about Androxal when I consider RPRX as an investment. There are no data to my knowledge on bone density effects, nor would there be any reason to suspect that it would influence bone density except indirectly (eg, increased testosterone-->increased muscle mass-->increased strength-->catabolic state for bone).
I wouldn't worry about bone effects in men. If you read up on the epidemiology, it is primarily a women's health issue. Osteoporosis in men is certainly under-recognized, but not an epidemic as it is in women.
Also, it seems to me that a primary endpoint for Proellex should be rates of hysterectomy for bleeding problems and endometrial cancer rates. Go for the really hard endpoints if this stuff is so great. Why should primary doctors presribe this stuff other than symptom relief?
There is a profound need for drugs that provide effective, safe symptom relief, so I don't see a problem here. The widely used alternative is Lupron/Lucrin, which is a nasty drug. For uterine fibroids, Proellex probably provides shrinkage, although we can't be absolutely sure because they haven't done a study with an MRI baseline.
Correct me if I'm wrong (here's my skeptical side), but I suppose that fibroid problems (since they are so common) are the number one reason for women having hysterectomy surgery and a 'bread and butter' income source for GYN surgeons.
Dewophile could provide a much better answer to this than I can, but most ethical physicians prefer to try a noninvasive alternative first. Plus, if promoted correctly (and if direct-to-consumer advertising continues) women will be quite aware of their treatment options.
Lastly, but not leastly, do women with symptomatic fibroids have higher rates of endometrial cancer then women who don't?
I didn't know the answer to this previously, but according to the Mayo Clinic utermine fibroids are not associated with an increased risk of uterine cancer. Thanks Google!
I think that this company may be on to something. The pipeline seems to be pretty good, but what is the competition up to? How is the cash position related to the burdens of proof of utility and are there dilution concerns, etc.
There are a number of competitors in development. I think the only one to worry about is if someone steps up to the plate to develop RU-486 for this indication. For reasons discussed elsewhere, I don't think this is going to happen.
Cash: According to the CEO, they are done raising cash. The company has enough cash to take them through an eventual sale (if I recall correctly, ~$45 M, but I might be mixing it up with one of my other holdings).
Remember that management wants to sell. They have no ambitions about becoming an integrated pharma or any of the other highfalutin' crap you hear from just about every other biotech.
What is your opinion on this company in terms of management?
So far, so good. This is the one and only case where I actually wish management would be more promotional, and the CEO has a motor mouth, but I have no issues with the way the company is being run.
Sorry if you've covered this ground before but I'm really intrigued by this company as an investment possibility and you are obviously the person who has the info.
We have covered this ground before, so I would suggest you review the old posts from myself and Dewophile and the follow-on threads for more accurate information than the above.
If you really want a comprehensive review of RPRX, subscribe to David Miller's newsletter. I'm in the biotech industry, and I learn something new from BTM or BSR or whatever it's called now on a regular basis. Credit where credit is due.
I hope David is wrong about DOR. I don't have a position, nor will I take one, but the evidence I've seen for efficacy is so strong that it would be a real shame for patients if orBec isn't approved.
Shears--RPRX
>I reviewed your recent posts and this oldie but goodie<
Don't have time to answer in detail right now as I'm in a meeting, but if you look in the i-box you'll see a link to an updated version of the RMF for RPRX.
RPRX
I think the market cap for RPRX is crazy, or else I wouldn't have repurchased my shares after paying the tax man. It is reasonable that RPRX should have a $250 M++ market cap right now based just on Proellex.
In my view--and, I believe, in Dewophile's view--RPRX is as low-risk as you can get for a biotech (which is to say, still pretty risky). I guess people would rather throw money at much longer shots, of which any of us could name dozens.
From a clinical viewpoint, I don't see many instances where the evidence for efficacy is as clear-cut as with Proellex, nor do I see many instances where the superiority over current therapies in terms of both safety and efficacy is so obvious. I also find Dewophile's confidence in the safety very reassuring, given that he works in reproductive medicine. I find it reassuring that I have yet to hear substantive criticism from anyone--either online or among my colleagues in medicine and industry--about Proellex. I'd also like to note that the data from agents with similar mechanisms of action--mifepristone and asinopril--are also very supportive.
In short, I have no idea why the share price is so low unless it is related to trading considerations on the part of larger investors. Which is fine, I guess, because I plan to double my position over the next few months.
>Dr.F stated that his 5 year vision for Medicure is to become a Pharma in their own right.<
This sort of statement scares me right off. There are so many hurdles and costs between a biotech just starting phase III and becoming a real pharma that I'd put the odds at <5% for success.
I much prefer RPRX's approach. Build value and then sell.
GENE
Up 86% for no reason at all. Tried to short, and of course E-Trade is not accepting online orders at this time. Toooo lazy to call, but for those of you who are more ambitious than me, feel free.
>think the biotech shorts are now also short on courage. The phrase " binary event " has them peeing their pants.<
I don't know what's going on, unless it's the aftereffects of DNDN, but my portfolio has been on fire for a while now.
Dew, any thoughts? Last year you called the top (for my portfolio, at least) within a few days.
Hi Dew,
Might be better to move the obsolete entries to the bottom rather than delete because the websites for each of the meetings are listed. I actually look at the calendar every once in a while to find the right website.
OPXA
Quantumdot--I'm going to take a very close look at this one. You're right that the initial data are impressive, although the market doesn't seem to agree as it's almost 1 pm and it has only traded about 11k shares.
I might wait until after they raise cash...I know from personal experience that MS trials burn cash like almost nothing else.
What do you mean? $4 is an ambitious target. I'd be happy with $3.00.
I have now seen it.
I generally don't pay attention to analysts unless they start covering a stock I already own. AIS has a lot of potential, regardless of whether a bunch of hacks cover it.
Quantumdot--this was discussed ad nauseum earlier. The inverse dose-response for endometrial thickness is expected based on the mechanism of action of the drug. And it's good news because the most efficacious doses are least likely to cause endometrial thickening.
Pathetic performance today.
RPRX
On initial review, these data are excellent and consistent with what was seen for the interim results. Will re-read and compare later.
Beyond efficacy, there were no real differences in the number of patients who reached the endometrial thickness threshold of 14 mm between the 25 mg dose and placebo. Of course, the histopathology is what matters, but this information is comforting.
RPRX really shouldn't be sitting at $10.40, particularly after these results.
Book Review--Valuation in Life Sciences by Bogdan and Villiger
One word: Kee-rap. Or is that two?
I'm pretty sure that there are a few valuable nuggets of information in this book, but it is so poorly written and edited that it is virtually unreadable.
Aside from that, the real options method of valuation (the author's preferred method) is far too complex to be of any use to the individual investor. I had to read it three times just to figure it out, and there's no way in hell I'm ever going to be able to use it. Put that together with poor writing, and you've got a big waste o'time and money.
Hmm...didn't realize they were that bad. Still, I wouldn't go so far as to sell based on a Dawson-James pump.
Anyone have an opinion on Dawson-James? Are they pay-to-play? Just checked them out and I don't think so.
Wondering because they came out with a ridiculous $4 target on AIS today.
Check out Tekturna's label: specifically states that adding a DRI to an ARB provides additional BP lowering efficacy.
My biggest gainers were ANX and AIS, strangely enough, but everything was up in my biotech portfolio with the exception of JAV and RPRX (which only went down a little).
Will the DNDN decision kick off a biotech rally?
Made a boatload today, and I didn't own DNDN.
Just wondering if anyone has thoughts.
>While not a certainty, if FDA does not issue a full approval now, I would be as shocked as I am today.<
Don't be shocked if they don't approve. If there's one thing I've learned in the past 10 years, the FDA rarely does the right thing.
DNDN
I'm not really paying attention 'cause I'm at a meeting, but isn't the DNDN decision being rendered today?
Nope, not me. I'll probably buy more but haven't been buying today.
The biotech calendar in the ibox is a hell of a lot better. I wouldn't be surprised if Feuerstein just copied it (which, of course, is just fine).
>Jav is a hyped stock.<
I'll take my money where I can get it.
Dyloject will be a very easy sell in Europe and elsewhere because of the bolus formulation and the fact that it is nonirriating. The marginally better efficacy is also good from a marketing standpoint.
PS: No phase III studies are required for the intranasal ketamine. You should watch the latest presentation before spouting.
One more PS: I've been repurchasing my RPRX at current levels.
J
>Why spend more money for Exforge ?
It's my understanding that both Ace Inhibitors and Angiotensin Receptor Blockers prevent or block Angiotensen II<
I would have answered this sooner, but--strangely enough--I'm at a meeting for a new antihypertensive.
The answer is yes, you are perfectly correct. However, ACE inhibitors and ARBs block different steps in the cycle: ACE inhibitors prevent conversion of angiotensin I to angiotensin II by angiotensin-converting enzyme, and ARBs block the interaction between angiotensin II and the angiotensin II receptor. [As an aside, the direct renin inhibitors block the conversion of angiotensinogen to angiotensin I, the very first step of the cycle.]
So, the question is, why do you need an ARB when you can block production of angiotensin I in the first place? And, of course, with the advent of the direct renin inhibitors the question would be why do you need ACE inhibitors or ARBs at all when you can block the first step in the renin-angiotensin system?
The first answer is that nothing is 100%. In fact, it's been shown that when you combine various drugs that act on the renin -angiotensin system, you can get additional BP reductions. That is to say, you can put an ACE with an ARB, or a direct renin inhibitor with an ARB, and get additional BP-lowering efficacy. Why? I won't get into all the reasons for all of the steps, but one example is that there are non-ACE pathways for the conversion of angiotensin I to angiotensin II.
The second answer is that many patients do not tolerate ACE inhibitors well. ACE inhibitors are well-known for causing cough. Similarly, some patients do not tolerate ARBs well.
The third answer is that there's always room in the therapeutic toolkit for more and better-tolerated antihypertensive agents. JNC 7 recognizes the need for multiple antihypertensives to get to goal; in fact, studies show that patients need, on average, 2-3 agents to achieve their goal. And the more comorbid conditions patients have (eg, diabetes, renal disease, etc), the more antihypertensives they need to get to goal.
The fourth and fifth answers revolve around compliance and cost (I think Dew and I have already addressed this adequately).
HNAB
Talk about going straight down the toilet...this was a promising company, and I made a ton on it last year. I'm starting to question whether HNAB will survive.
The question I would ask is whether this issue is related to NVD's overall platform, or whether it is specific to the reformulation of odansetron. I don't think it's the former, given that they have one product approved already. I am surprised that NVD's shares haven't taken more of a beating today as it *does* call into question their technology.
>The comment about putting it in the water was said pretty much tongue-in-cheek. I apologize if it upset you. Most cases of liver problems can be done away with simply by switching statin types and dosages, so putting only one type of statin in the water doesn't really make sense.<
No, water doesn't make sense, but what about a "baby statin?" Say 2.5 mg of atorvastatin? The lowest dose is 10 mg. You could even combine it with low-dose aspirin and maybe some low-dose ER niacin.
Not sure what the threshold is for benefit. 2.5 mg isn't going to do much in terms of cholesterol lowering, but the so-called benefits beyond lipid lowering might still be present.
>Amlodipine is in Lotrel. I would buy Benazepril(generic) and generic Norvasc(Amlodipine) and drop the Lotrel. Bad news ?<
Except then you'd have 2 copays, and your compliance with your medication would like be worse. Particularly if you were taking multiple concomitant medications for other conditions.
The primary rationale for combination antihypertensives revolves around compliance and persistence. Multiple studies have shown that the more pills you take, the more likely you are to stop taking your medication. That, and the Joint National Committee 7 guidelines acknowledge that most patients with hypertension require 2 or more agents to get to goal.
Given the sales of combination antihypertensives like Lotrel and the various HCTZ combinations, among others, physicians and patients buy into this argument.
It's excellent news for Novartis because Exforge can launch early. Exforge is the combination of an ARB and amlodipine (Norvasc).
Like hydrochlorothiazide, every pharmaceutical company is going to come out with an amlodipine/product combination now. Norvasc is a great drug.
[Edit: oops, I see the answer has already been given. I didn't peek. Really]
>In the condition Progeria children born with this congenital disorder begin to assume the appearence and disabilities of old age typically well before they reach ten years of age.<
The primary defect in these children is not shortened telomeres. It's a mutation in a DNA helicase that is involved in homologous DNA repair and, probably, in nonhomologous end-joining pathways. The gene (WRN) may be involved in resolving something called the Holliday junction, a 4-stranded DNA intermediate in the homologous DNA repair pathway. If the Holiday junction is not resolved, it can lead to multiple DNA breaks, which of course may lead to all sorts of problems if improperly repaired or left unrepaired.
In short, aging--whether it be 'natural', or accelerated by environmental insults (eg, UV radiation, ionizing radiation, smoking, caffeine, etc) is probably caused primarily by unrepaired or improperly repaired DNA damage.
Shortened telomeres are a secondary consequence of Werner's syndrome. I don't think this is the primary defect.
Mother nature still a rich source of new drugs
What ever happened to Shaman Pharmaceuticals
By Julie SteenhuysenMon Mar 19, 12:14 PM ET
At least 70 percent of all new drugs introduced in the United States in the past 25 years come from nature despite the use of sophisticated techniques to design products in the lab, researchers reported on Monday.
Their study indicates that a back-to-nature approach might yield better possibilities for companies looking for the next blockbuster drug.
Drug discovery hit a 24-year low in 2004, with just 25 unique compounds known as new chemical entities introduced that year, said David Newman, who runs the U.S. National Cancer Institute's natural products branch.
"Chemists started making libraries of hundreds of thousands to millions of compounds. But they were simple compounds," he said in a telephone interview.
"Mother Nature doesn't make simple compounds. Mother Nature wants compounds that fit into particular places."
Newman links a dearth of new drug development at U.S. drug companies with the shift away from nature as a main source of drug compounds.
"Wyeth and Merck are the only two U.S. manufacturers of that size that still use natural products as one of their sources to look for drugs," he said.
Newman's study found more than two-thirds of all drugs discovered in the last quarter-century have come from nature. He believes linking nature with advanced chemistry techniques that combine a vast array of molecules to speed drug development will likely yield much more fruitful results.
Newman and colleague Gordon Cragg reviewed the origins of new drugs developed in the past quarter-century and found that despite the introduction of a host of high-tech drug discovery tools, natural products continue to be the inspiration for most new drugs.
NATURAL INSPIRATION
Aspirin, a staple in most medicine cabinets, was originally obtained from the willow tree. The widely used chemotherapy treatment Taxol was derived from Pacific yew tree.
"Even though it is made in a different way now, it is absolutely identical to the material that comes from the yew," Newman said.
Likewise, the colon cancer treatment irinotecan, a standard chemotherapy that interferes with the growth of cancer cells, and topotecan, a chemotherapy used for ovarian cancer and lung cancer, are both modifications of the tree Camptotheca acuminata, a native of China.
In fact, Newman and Cragg found that about half of all anti-cancer drugs introduced since the 1940s are either natural products or medicines derived directly from natural products.
Newman's study, to be published in the March 23 issue of the Journal of Natural Products, is an expanded and updated version of reports published in 1997 and in 2003.
The researchers sought to trace how nature has inspired drugs currently on the market.
"A chemist would never conceive of making Taxol unless he or she had seen Taxol first," Newman said. "So what we looked back at was, what was the intellectual underpinning of the drugs that were currently on the market."
Newman said the advent of new drug discovery techniques such as combinatorial chemistry in the 1990s diverted many drug company resources away from a rich source of new drug compounds.
The technique allows for the rapid combination of many different but similar compounds -- basically industrializing the role of the chemist.
"Mother Nature's influence is alive and well," Newman said. "But you have to look for it in a subtle way. She doesn't come out and wave a broom in your face."
NKTR
Biophud,
NKTR is one of those companies that I think should be doing better than it is in terms of stock price, but it's a perennial disappointment. I don't know why. I think it is one of those stocks that's followed so closely that any potential gains are attenuated by investors taking small profits or selling once they've recovered their losses.
There's no good reason for NKTR to be sitting at $11-12, but I also think it's not going anywhere soon. You're better off finding something on the verge of being discovered by the unwashed masses, even with the market downturn.
Just my opinion. But I'm much more into uncovering stocks that are values because they're undiscovered, rather than stocks that are values because they've been beaten up by the market. I think both strategies are equally valid, I just have more success with the former.
JAV
Well, I never got around to the RMF...but if anyone is interested, the Cowen presentation is just as good.
www.corporate-ir.net/ireye/conflobby.zhtml?ticker=JAV&item_id=1491284
My only question: what's a conflobby?
JAV
Nice, if a little overconfident. I was looking for $12-$13 or so. I'm not sure $18 is a reasonable target but I do think there is significant upside from here. Dyloject will be a very easy sell.
RPRX
But there are no added phase II studies. At least according to this press release. Straight to phase III.