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Dew, Concerning CX-717/ADHD, the key factor for Cortex at this early stage is just to get a good BP partner for the program. And of course first we need to get the dosing liberalized. So to worry about Strattera not setting the world on fire isn't anywhere near the top of our list of worries. One could even argue that Strattera's woes make the opportunity even larger for CX-717, since if Strattera bombs out that would be one less non-stimulant competitor in the picture. Bottom line is that a good ADHD med without the systemic side effect baggage of amphetamines and methylphenidate is still going to be a hot property. Just because Strattera isn't cutting it doesn't mean a better non-stimulant like CX-717 won't receive a warm welcome.
BTW, it looks like your analysis of Dendreon was a lot more well grounded in reality than was mine. I guess I let my enthusiasm run away too far to the upside, and got a little carried away by gold fever :o)
MarketFest, I seem to have enough trouble managing normal long positions without adding the complexity of options, spreads, etc :o) Protective puts seem like a sound idea if you're entering a binary event with a big long position, but I'll probably leave to advanced stuff to you guys :o)
As you said, one problem with options strategies for the biotech sector is the tendency for timeline slippage of bio events, and the fact that options always have that pesky expiration date looming. Long term warrants would be ideal if they were more available for bio stocks.
Oh well, with the "Dendreon gambit" behind me, and the "Cortex caper" still a way off, I'm off to search for some other potential near term bio plays.. With the AACR and ASCO meetings coming up, there might be some good near term cancer plays out there. I don't follow the sector that closely anymore though, other than a few like Exelixis and Spectrum/Pharmion. I had ArQule on my watch list as a stock that seems to be highly regarded science-wise, so maybe I'll check them out more closely. Jumping into a near term situation with minimal DD is usually a recipe for disaster however, so I'll tread lightly for now.
MarketFest, I'm not all that familiar with options strategies. If you sell/write a call option while owning the underlying stock, but then decide to dump the stock, what happens to the call option you sold? If you no longer own the underlying stock, then you presumably wouldn't be able to deliver the shares if the call owner excercises. So that would lock you in to maintaining ownership of the stock?
MarketFest, OT - Well, I decided to unload my Dendreon position since it looks like there's going to be major volatility from here on out. The stock has become one hot potato. I managed a reasonably good 33% gain, so I guess I'll have to be satisfied with that. Dew was basically right about the risks with that one, and there's no sense getting too greedy. I figure it should fluctuate considerably between now and May 15th, with the mid-upper $20s at the high end and somewhere in the teens on the low end. The Dendreon kitchen has gotten way too hot for me though.
MarketFest, OT - Yes, still long. I was away from the computer most of today so I wasn't watching the market. I guess there had to be some consolidation eventually, so a pullback is probably healthy. I still think DNDN will gravitate up toward the mid-high $20s over the next 4 week period as we approach the FDA decision. $25/share roughly correlates to a market cap of $2 Bil, and $30/share to $2.5 Bil, and that's the approx valuation range I'm estimating to be reasonable when all factors are considered (pre-decision). Of course my guesstimate may not ultimately jive with the market's opinion, so we'll see what happens.
Here's a new group of Exchange Traded Funds for the various bio/healthcare subsectors -
http://www.healthsharesinc.com/
Currently Traded ETFs
ETF Name Symbol
HealthShares™ Autoimmune-InflammationArthritis, Multiple Sclerosis and Lupus HHA
HealthShares™ CancerLarge Cap Cancer Companies HHK
HealthShares™ Cardio DevicesStents, Valves and Pacemakers HHE
HealthShares™ CardiologyCoronary Artery Disease, Congestive
Heart Failure, Hypertension HRD
HealthShares™ CompositeTop 80 Stocks by Market Cap in
HealthShares Indexes HHQ
HealthShares™ DiagnosticsAnalysis, Identification & Visualization of Disease HHD
HealthShares™ Emerging CancerSmall Cap Cancer Companies HHJ
HealthShares™ Enabling TechnologiesGenomics, Proteomics and Robotics HHV
HealthShares™ GI/Gender HealthHeartburn, Acid Reflux & Sexual Dysfunction HHU
HealthShares™ Metabolic-Endocrine DisordersDiabetes, Obesity, Kidney & Liver Disorders HHM
HealthShares™ NeuroscienceAlzheimer’s, Depression & Parkinson's HHN
HealthShares™ OphthalmologyGlaucoma, Diabetic Macular Edema & Macular Degeneration HHZ
HealthShares™ Patient Care ServicesAssisted Living Centers, Nursing Homes & Hospitals HHB
HealthShares™ Respiratory/PulmonaryAsthma, Emphysema, Tuberculosis & Chronic Obstructive Pulmonary Disease HHR
Jerry, If you're out there, what was up with MEMY today? All I saw was a press release saying they had completed enrollment in their AD trial. That didn't seem like something to move the stock up 50% though. Just curious if you've heard what else might be going on? Maybe there are buyout rumors, or someone partnering one of their programs (please say it isn't Cortex.. :o) Thanks.
BTW, I still think MEMY looks like a doggy company, but sometimes dogs can miraculously sprout wings and fly :o) Your reverse head/shoulders, inverted cup/saucer stuff turned out to be right on the mark for both Cortex and MEMY.
Onthelak42, Was that press release on the completion of enrollment the reason for this big move? I don't get it. Thanks for any insights.
Alertmeipp, That's probably a good idea. I haven't used options before (well once), but I probably will if I decide to stay invested through the FDA decision in May. Otherwise I don't see a big downside risk in the pre-decision period that we're in now. I should at least get up to speed on them though, and will check them out. Thanks for the suggestion :o)
MarketFest, Thanks. I guess sometimes it's better to be lucky than good :o) I'm planning to ride it for what I can get between now and the May 15th FDA decision, and stay flexible. I'm not sure yet if I'll stay in for the FDA decision itself, or if so with how much. I consider this one a gift from the bio gods, and will try not to get too greedy. I'm still figuring the mid-high $20s is likely pre-decision, but will continue to evaluate the situation as the May 15th period gets closer :o)
That analyst's firm had/has a big short postion, and they're desperate in the extreme, you gotta love it :o) Just about every firm on Wall St was short prior to the FDA panal meeting/vote, and many like Brean are still in hot water trying to unwind those positions. The panel threw everyone a major curve ball by changing the efficacy criteria during the vote. That development really couldn't have been predicted, and Wall St got caught with their pants down bigtime. Couldn't have happened to a nicer bunch of pricks IMO. Too bad :o)
MarketFest, "My prostate never felt better", to quote someone over on Yahoo :o)
Aiming, That's a good question. One would think that the AD PET scan trial is blinded until the end, but I'm not sure. Neuro may have the answer if he's out there.
I'm also starting to get curious about the non-Ampakine programs that might be under consideration. At the last presentation, Dr. Stoll said that they had passed on several opportunities (one primarily due to cost, Bicifadine), had done DD assessments on 4 more programs, and had another 3 under consideration. I have no idea what/whose programs these could be, but it would be interesting to speculate on the possibilities. The only other neuro related companies I follow to any extent are Acorda and Torrey Pines, so I can't even venture a guess as to what programs are possibly being considered. One would assume that the programs should be for orphan type indications, although the one that Cortex almost pulled the trigger on (Bicifadine) was for neuropathic pain, which I don't think is an orphan.
Alertmeipp, The most recent timeline estimate for the Neurodegenerative/High Impacts deal is Q3 (from the slide at Dr. Stoll's last presentation). I had previously been figuring mid Summer. The other BP deal, for CX-717/ADHD, should occur sometime after the FDA dosing decision (unless of course Cortex decides to do the Phase 2b inhouse, and seek an even larger deal after that). With Organon now being acquired by Schering, the Schizo/Depression rights could soon be up for grabs, so the possiblility also exists for some type of all inclusive mega deal.
These deals all take time to put together though, so I'm not expecting a deal announcement before the CX-717 dosing decision. The exception would be the non-Ampakine inlicensing deal, which might conceivably occur prior the CX-717 decision (Stoll's estimate was for sometime in Q2).
Spartex, OT - I started those boards originally as an OT outlet to help keep the Cortex board more focused, but they ended up mainly being a storage area for articles on companies I follow, to save on printer cartridges. Now I usually just copy and paste the articles of interest directly into my computer.
Even though the Cortex news flow is currently very slow, I'm going to try to refrain from too many more Dendreon related posts on this board since things may be getting too far OT. Dendreon seems to be a real sore point for the Dewmeister though, and annoying His Royal Dewness for a couple days was fun :o)
Lumpy, Thanks for the input. I'm figuring to ride the stock for whatever upside it has in the pre-decision period, and then reevaluate the situation from there. If we get in the mid-high 20s in the next 4 weeks, I may just take my gains and sit out the decision. I realize numerous risks remain and so am staying in flexible mode.
Dew, I will if you'll promise to monitor your Adderall dose more closely :o)
Dew, Good luck with your goat farm :o)
Spartex, OT - When you consider the $1 Bil+ revenue potential for Provenge, rapid ramp up, and label expansion/off label use, the current $1.5 market cap is exceedingly cheap. The stock was so incredibly cheap prior to the FDA panel meeting (mkt cap approx $400 mil) due to the widespread consensus that it wasn't going to get approved. Now that approval seems very likely, having a $1 Bil blockbuster should translate to a $4-5 bil market cap immediately upon approval ($50-60/share), and move steadily higher from there toward a $10 Bil+ market cap ($120/shr). And along the way should come the buyout bids :o) That's a phenomenal return starting from $15 or $18. Even in the next several weeks leading up to the FDA decision, one would conservatively expect the stock to get to around $25-30 or so. That's relatively easy/low risk money folks, like the Cortex move from $1.20 - 2.40 following the Roth conference.
Ampakineman, I'll revise that then, and take at least 2 weeks off from posting if my current gambit pays off :o)
I really like the chances with Dendreon. The FDA appears to be bending over backwards to approve. I can see where Dew and the other critics are coming from though. The smart money went against Dendreon's chances when they saw Provenge fail to meet the time to progression endpoints. I hadn't been following the stock at all at that time, but the obvious conclusion would have been that the odds were bad. The paradigm shifted totally however when the FDA panel "liberalized" the criteria for approval. They clearly want to approve this drug. The other department (run by Dr. Pazdur) would have almost certainly shot it down, but they aren't the ones deciding the matter (see David Miller's and Feuerstein's articles). This is going to be fun :o)
Sorry for all the Dendreon posts, but here's an interesting one from the Advanced Prostate Cancer website. The author gave a testimonial at the recent FDA panel meeting -
http://advancedprostatecancer.net/?cat=5
>>> April 5, 2007
PROVENGE – WHY THE FUSS?
Last Thursday, March 29, 2007, I had the opportunity to participate as a patient advocate in the FDA’s Tissue, and Gene Therapies Advisory Committee. The purpose of the committee meeting was to evaluate the application of Dendreon Corp for approval of their new drug, Sipuleucel-T (Provenge).
I want to clarify the facts and dispel some of the rumors about Provenge. I also will share my experience and feelings as an active patient advocate at the committee meeting.
WHAT IS PROVENGE
Provenge has been receiving a huge amount of attention from the general press, the scientific community and from the prostate cancer community. This extraordinary interest is due to the fact that, if approved, Provenge would be the first and only therapeutic immunological vaccine approved by the FDA.
First and most important, I want to clarify that Provenge is NOT a cure for prostate cancer (PC) as some people believe. It is a treatment that has shown the possibility of providing advanced prostate cancer (APC) survivors the ability to extend their life with minimal side effects while maintaining their quality of life (QOL).
Currently, once an advanced prostate cancer (APC) survivor becomes hormone refractory (HR) there remains only one additional nonpalliative therapy approved by the FDA. Chemotherapy with docetaxel, also called Taxotere, brings with it major negative side effects, but does provide life extension of an average of 2.5 months. However, many men elect to completely forgo Taxotere in order to preserve their QOL, or fail to complete the full course of treatment because of the significant negative side effects.
Provenge, if approved, could be used at the point that Taxotere is currently prescribed. If it works, it could extend life for an average of 4.5 months with a minimum of side effects. There has been some additional research which demonstrates that Provenge combined with Taxotere can extend life for an average of fifteen months.
WHAT ARE THE SIDE EFFECTS
The side effects of Provenge seemed to be limited to flu like symptoms, which are experienced by patients after the infusion, have duration of one to two days and are grade 1 or 2 (not requiring hospitalization). These side effects include chills, fever, headache, weakness, nausea, vomiting and shortness of breath. About 98.6% of the subjects who received Provenge during the clinical trials experienced some of the side effects.
There is also some evidence that there is a small, but not statistically significant, increase in the risk for a cardiovascular event.
WHAT MAKES PROVENGE DIFFERENT
Cancer vaccines are designed to treat existing cancers (therapeutic vaccines) or to prevent cancers form developing (prophylactic vaccines).
Provenge is an example of a therapeutic vaccine, as it is administered to people who are already fighting advanced prostate cancer. Prior to treatment, the prostate cancer tumor is not recognized as being a foreign body, and so the immune system fails to mount an attack on the tumor. The vaccine is designed to stimulate the person’s own immune system so that it identifies a prostate cancer tumor as being a foreign body and launches an attack on the cancer.
The administration of Provenge requires three separate infusions, each about two weeks apart. Two to three days prior to each infusion the patient must go through a process called apheresis in which white blood cells are harvested. The apheresis process takes several hours to complete and some people report it to be unpleasant. The cells are then shipped to a laboratory where they undergo a manufacturing process that places an antigen on to the surface of the white blood cells. This antigen is designed to identify and target PAP (prostatic acid phosphatase), an enzyme that is expressed on 90% of all prostate cancer tumors, as a foreign body, causing the immune system to launch an attack against the tumors.
Currently, there are only two prophylactic cancer vaccines approved by the FDA. These vaccines are designed to prevent virus infections that can cause cancers — the hepatitis B vaccine (liver cancer) and the human papilloma virus (cervical cancer) vaccine.
There are no approved therapeutic vaccines, so if the FDA approves Provenge, it will be the first one licensed. However, several other therapeutic vaccines are in large scale clinical trials for many different cancers.
STATISTICAL PROBLEMS WITH THE CLINICAL TRIALS
There were a number of statistical issues with the clinical trials of Provenge. There were two separate trials involving men with hormone refractory but asymptomatic recurrent PC. Both trials had very small sample sizes (trial 1, n=127 subjects, and trial 2, n=98 subjects) and both used as a primary endpoint the time to disease progression. Neither trial reached a statistical significance as to this end point.
However, a retrospective analysis of the data did show that there was in the first study a statistically significant difference for survival time (4.5 month) between the treatment group and the placebo group. The second clinical trial was terminated early, had an even smaller sample size, and did not show a significant difference between the two groups as to the primary endpoint of time to disease progression or to the overall survival time (3.3 month overall survival difference).
As already indicated, in the first trial the overall survival time was statistically significant. However, since the sample size was small (n=127), a number of the committee members expressed concern that a different outcome of just one or two patients would have yielded entirely different statistical results.
In addition, I was bothered by the fact that the placebo group in study 2 had a longer survival time then did the treatment group in trial 1.
The racial composition of the first trial was about 90% Caucasian and in the second trial the Caucasian population was slightly higher. This raises the question of whether inferences drawn from the trials can be generalized to the broad population. This is a particularly significant issue as a higher percentage of African-Americans get prostate cancer as compared to the Caucasian population, and prostate cancer in African-American men tends to be more virulent.
THE ROLE OF PATIENT ADVOCATES
After I decided to go to the committee meeting and provide testimony, I spent some time writing what I wished to share with the committee. A few days prior to the committee meeting I thought about not testifying. Going there would require that I lose a day and a half of work, cost the price of a hotel room and four meals and require that I drive for six hours to get to the meeting and six hours to return home. Why would I want to do this? I assumed that the committee really couldn’t care what I had to say. The decision would be based on the science and on the statistics. Public comment was to appease the public and nothing more. So why waste the time and money?
I soon found out that I was very wrong. About fifteen patient advocates took advantage of the opportunity and spoke to the committee. Each of the presentations told a story about the speaker’s personal journey or that of a husband, father or grandfather. They were all moving, and reflected the desperation that so many of us with advanced prostate cancer feel. As each advocate spoke, the committee members paid great attention, many of them leaning forward in their seats as they listened to each individual’s presentation. In one instance I thought I saw a tear wiped from someone’s eye.
The proof of the pudding came as the meeting was drawing to a close and the final voting began. All committee members voted without much comment that Provenge is reasonably safe for the intended population. Many committee members did expressed concern about the potential for a cardiovascular event and urged continued monitoring of this problem.
When they came to the final question, “Does the submitted data establish the efficacy of Sipuleucel-T (Provenge)?” the result was different. The first three committee members all voted no, but all of them went on to qualify their votes. The members struggled, as it was very clear they wanted very much to vote yes. Their explanations for how they voted more like an apology to those of us who had testified and as an expression of their feelings of concern that there isn’t any good alternatives to treat patients with advanced prostate cancer. Many of their comments reflected the concerns and thoughts that had been raised by the patient advocates. In some cases, we actually heard parts of our stories repeated back to us.
After the third committee member went through his very uncomfortable explanation, the committee chair, Dr. James J. Mule, stopped the voting process and addressed the members of the FDA who were present. He requested that they reconsider the wording of the question, as all of the committee members who had spoken indicated they did feel that there was a strong suggestion that Provenge did in fact extend life.
The FDA responded that they could not change the question, as this was a standard in all evaluations.
The next committee member again voted no, but with all the twists and turns that had already been expressed by the prior members. After this vote, the FDA stopped the process and changed the question for the committee to evaluate. The question was modified to whether or not the data submitted demonstrated substantial evidence that Provenge contributed to the extension of life (as opposed to establish the efficacy of the treatment).
The voting recommenced with the final vote of 13 to 4 in support of affirming the changed question! This was a historic vote that took a tremendous amount of courage from the individual committee members. I salute those members who voted in the positive, as they understood the nature and ramifications of the vote.
This vote not only offers hope to advanced prostate cancer survivors, but it will encourage the many biotech and drug companies that were in attendance observing the committee procedures. These companies are involved in developing additional vaccine treatments not only for prostate cancer, but also for other cancers. Since I also have kidney cancer, I have already been invited by one biotech group to meet with them and discuss advocacy issues.
The Cellular, Tissue and Gene Committee is only an advisory committee to the FDA, which has agreed to fast track their final decision. They will make their decision whether or not to approve and license Provenge by May 15. Most of the time, the FDA goes along with the advisory committee’s recommendation; however, they are not required to agree with the committee recommendation. Only time will determine what their ultimate decision will be.
PROVENGE’S DETRACTORS
Not everyone is in agreement that Provenge should be approved. The committee members who voted in the negative expressed the concern that the clinical trials did not establish that Provenge actually provided any real survival benefit. They may be correct, but with the FDA’s approval, a patient and his doctor can make the decision themselves, weigh the risks and benefits, and decide whether to use the Provenge. Men in this position are a desperate group with no other options. It should be up them to make the decision as they are in end stage disease and are looking at their own imminent death.
The following is from the google group alt.support.cancer.prostate
” I was in the clinical trial, and Provenge did nothing to help my condition. It probably hurt in the long run. My PSA prior to the trial was 550.58. After the trial it was 1399.7 They cracked the code and found that I had gotten the vaccine, not a placebo. They have not been able to bring the PSA down. My latest number was 3174 and I am now on Hospice…….
…….Even if it is eventually approved, I don’t believe that it will be a commercial success due to its delivery procedure. I had to go to a lab where my white blood cells and plasma were extracted. That was an unpleasant 2-3 hour procedure……. The side effects (of the treatment – my addition) were very unpleasant. I was incapacitated for 2 days following the treatment.”
Jim
Dendreon, the manufactors of Provenge, are still running a third study with a much larger sample. Their goal is to run 500 subjects; they have already enlisted 400 people. (For further information, or to join the study, you can contact Dendreon at 1-866-477-6783.) The primary end point of this study is survival time, not progression to disease, as it was in the prior two trials.
This trial should be definitive and would determine if Provenge actually provides an increase in survival time. At the earliest, this study would not be completed before 2010. Given the lack of treatments currently available and that in every 24 hours 74 men die of advanced prostate cancer, many of us believe that this is too long to wait.
It has been suggested that Provenge should be provisionally approved with a complete review at the conclusion of this additional trial. However, it will become next to impossible to complete this trial as the recruitment of men into this study will become very difficult. How many of us would be willing to participate in a clinical trial and possibly receive a placebo when our doctors could just write a prescription?
The other issue is the economics of Provenge. Clearly, the development cost and economic risks to Dendreon have been high. No agency, including the FDA, can control what would be the cost to the patient for the treatment. The treatment is complex and is individually manufactured for each patient. Would private insurance carriers, the VA, or Medicare pick up the treatment cost? I don’t know.
I don’t know what the treatments would actually cost. I have even heard that the cost could be as high as $20,000 per person. These kinds of costs, what ever they actually become, will surely be out of the reach of many people.
CONCLUSION
Provenge is not a miracle cure, but it does hold the potential of providing a personal miracle for some of us. According to current Seer Relative Survival Rates from the National Cancer Institute, the expected mortality rate for advanced prostate cancer is over 50% in three years from diagnosis. An additional 4.5 months would increase by 12.5% the life expectancy of the average advanced prostate cancer survivor.
Those of us living with advanced prostate cancer have already gone through the mill of barbaric treatments. We have had our prostates removed, frozen or radiated; often leaving them with various degrees of incontinence and impotence. Then, 30% of us had initial treatment failures, so we will try salvage surgery or radiation. Many of us will also start hormone therapy, which makes us into physical and chemical eunuchs. We lose the little sexual ability we may have managed to cobbled back together after the primary treatment and trade it in for hot flashes, loss of muscle mass and bone density, peripheral neuropathy, mood swings and a host of other ailments.
Despite the terrible suffering we have endured our cancer marches on. We then become hormone refractory, develop painful soft tissue and bone metastases, and then we die.
Why shouldn’t we have the opportunity to make our own decisions, weigh the risks and suffer the consequences? Maybe we will be around a little longer. Wouldn’t that be a nice little personal miracle?
Joel T. Nowak <<<
Dew, Here's David Miller's article on Dendreon. Sorry if this was already posted (and I hope he doesn't mind me reposting it here). This looks like a well balanced appraisal of the Dendreon situation -
>>> This is a funny business. Eight days ago, I think it is safe to say a preponderance of people on Wall Street thought I was a moron. My firm’s consistent bullishness on Dendreon’s (DNDN) Provenge was a source of more than a little mirth and derision from our peers. I’m the first to admit we haven’t called the price right since 2002, but I think we’ve been accurate enough on the fundamentals to help any investor who truly wanted the correct story on the company.
40 days
I am not crowing. I’ve been there, done that. In 2003, my firm was up 80% and I thought we were geniuses and everyone else on the other side of the trade was a moron. I read some of our stuff from back then and cringe at the arrogance. Madam Minxy Market taught me a thing or two since then. First, that it is not over until it is over. Second, that there is always another trade around the next corner that can make you look stupid.
The only solid rule in my business, after all, is that you’re only as good as your last trade.
With Dendreon, it is not over yet. In the next 40 days, the FDA will provide their opinion – which is the only opinion that matters – on whether or not Provenge is safe and substantially effective enough to allow it to be on the market. The advisory panel voted 17-0 in favor of safety and 13-4 in favor of substantial efficacy. Those are compelling votes.
But while the FDA almost always follows the recommendations of its advisory panels, it does not have to. I place the odds they will high, but there is a chance they won’t and smart investors need to factor that into their risk profiles. I’m not going to go into pages and pages of why I think the odds for approval are high, but I do want to correct what seems to be a common misconception out there. I also want to share a tiny insight I gained by being at the meeting that I think makes a difference.
Question Change
I’ll give the bears points for being right on the stock price for all of the last couple of years (up until Friday). I’ll also give them points for persistence. Let’s be honest with each other and say out loud that it takes some logical gymnastics to spin a 13-4 vote by the panel as a negative.
The bear argument revolves around the fact the approval question posed to the advisory panel was changed. Since more than one of the analysts who have written about this have the story wrong, I want to correct it here. Let’s start with the way the question was originally posed:
Question 8: Does the submitted data establish the efficacy of Provenge in the intended population?
The underlined word “establish” posed problems to the first three panel members who answered the question. They interpreted “establish” as something akin to “beyond a reasonable doubt” and were not convinced the data on Provenge met that high standard.
There was some back and forth about the question between CTGT Panel chair Dr. James Mule and the FDA’s Dr. Celia Witten. Dr. Witten is the head of the CTGT program inside the FDA and the person who is the lead decision maker for the FDA’s verdict on Provenge 40 days from now (though she doesn’t have the final say). There was talk about changing the question.
While the panel’s sitting biostatistician asked the FDA to define “establish,” a gentleman from the FDA’s “back row” gave a note to Dr. Witten and whispered something in her ear. She then changed the question to:
“Is there substantial evidence of efficacy?”
Her exact words when making the change were, “The regulatory definition is ‘provide substantial evidence’ so that is our standard. Is there substantial evidence of efficacy?”
I want to stop there and make a couple of observations about some of the research you might have read.
One analyst report said, “Surprisingly, today’s CBER panel chair changed the predefined voting question of efficacy during the voting process.”
This is incorrect. Dr. Mule did not change the question. Dr. Witten did. There is a big difference between the panel deciding on its own to change a question and the FDA department head responsible for making the decision on approval changing the question.
The same analyst calls the new question “post hoc” and “softer.” Perhaps, but that ignores the fact “substantial efficacy” is right from the FDA’s regulations. “Establish” is not.
One Passed Note Away From a Goat
Here’s the tip you would not have got unless you were at the meeting…
Recall that the decision for the approval of Provenge is in the hands of the CBER division of the FDA. Up until the first of March, there was a concern the FDA's CDER division – specifically Dr. Richard Pazdur’s Office of Oncologic Drugs – would get the review. CBER retained the review, as it should have according to FDA’s regulations.
Remember when I said a gentleman from the FDA’s back row handed Dr. Witten a note just before she changed the question? I think it pertinent that gentleman was Dr. Jesse Goodman, Director of CBER.
There were two to three bearish analyst notes that dismissed the panel because they felt the FDA would look askance at the 13-4 efficacy vote due to the change in the question. I’d be very interested to see how they get around these three facts:
1. The FDA itself changed the question.
2. The lead person in the evaluation of Provenge, Dr. Celia Witten, changed the question.
3. Dr. Witten changed the question after being passed a note by her boss, CBER Director Dr. Jesse Goodman.
I think those three facts tend to cancel out the idea the FDA is going to ignore the panel recommendation because the question was changed.
More to the point, the subtext of the bear’s position here is the FDA inherently does not want to approve Provenge. If that is true, then why did the two people most responsible for the review of Provenge change the question after three consecutive ‘no’ votes?
I’ve been a big proponent of the idea logic and regulatory decisions do not always go together. That’s one reason why our odds on Provenge’s approval in 40 days are not 100%. Some “logic,” like the idea the FDA does not want to approve this drug, simply flies in the face of fact.
Effect On the Sector
One reason I’ve been writing about Provenge is I thought an approval had a chance to benefit the entire sector due to it sending a signal that the FDA was going to be more reasonable. I’m no longer certain this is the case or, more accurately, I’m not sure the signal will last very long.
Dr. Richard Pazdur was at the CTGT meeting and was passing notes during lunch to Dr. Maha Hussain. Dr. Hussain is a sitting ODAC panel member and is serving as that advisory panel’s interim chairperson. I’ve written often about my belief that ODAC has degenerated into a rubber stamp panel for Dr. Pazdur’s peculiar ideas about how to get effective cancer drugs to suffering cancer patients (larger trials and stricter requirements).
After lunch, Dr. Hussain’s comments in regards to Provenge’s efficacy were delivered with more passion than accuracy. Many of her key facts were wrong and her assertions that Taxotere is an adequate drug for this patient population were contrary to statements she made at public scientific meetings. In sum, I believe this was a pretty good portrait of what Dr. Pazdur and ODAC would do if they got their hands on a similar application.
On May 9 and 10, ODAC meets in DC. On May 9, a superficially similar NDA for a drug from pink sheet company DOR BioPharma (DORB) called orBec will be in front of the committee. Despite potentially compelling efficacy data, I believe Dr. Pazdur will take out his “Provenge frustration” on orBec.
Worse yet, on May 10 ODAC discusses the risks of epo drugs (drugs to boost blood cells) when given to chemotherapy patients. I think it is highly likely Dr. Pazdur will be atop the grandstand on May 10, waving the banner of drug safety that seems so popular in Congress right now.
Between those two events, I think any halo given by a Provenge approval will be dampened. If I’m wrong and orBec is approved, and the panel decides not to go all medieval on epo’s safety issues, then the sector will rip substantially higher. Substantially.
But that’s another story. For the team here at BSR, we have 40 more days to find out if we get to keep our newfound genius status or whether we’re goats again.
One other thing: Amgen (AMGN) will have the most exposure to the May 10 ODAC panel meeting. The safety issues with epo have been worked into its stock price, though whether the effect has been too much or too little I can’t tell you. If the ODAC panel isn’t too negative on epo, then Amgen shares could recover some. I don’t think that’s the likely outcome, however, so if you are in Amgen, the IBB, or the BBH you might want to take stock of the issue. <<<
Dew, Yes, GTCB is interesting, and the biogenerics angle adds to that. Company management appears excellent, and the stock is cheap. I've got a list of several dozen promising bio companies, so I've added them to my list.
As I see it, the ideal way to participate in this sector would be to own roughly equal amounts of all these promising companies, and sit with them for the long haul as they gradually achieve success, occasionally pruning/adding as necessary - a "bio-gardner" approach :o) Unfortunately it takes a lot of capital to set up such a portfolio, hence my current concentrated "all in" strategy. You have to first have sufficient money before you can invest in the ideal way. Or you have to be young, with 20-30 years to grow your investments. At my age though (51) I no longer have the time factor on my side.
Dew, I think you're just pissed because you missed the boat on Dendreon. Just about everyone on Wall Street made the same miscalculation, so it's nothing to be ashamed of. At least you weren't short the stock :o)
Dew, OK, 1% of the company. That still seems like a gigantic position, though I guess if it's a part of a really big overall portfolio it might make sense. Fwiw, I just listened to the recent GTCB presentation (Cowen). Cox gives an excellent presentaion, and it's definitely an interesting company, but it seems like it's going to take forever. Who knows how long US approval for Atryn will actually take, and the DIC/Sepsis program sounds very risky, sepsis being a well known bio graveyard. Everything else they have is very early stage. With a long enough timeframe though, it could turn out to be a great investment, and you're definitely getting in on the ground floor.
Concerning my online credibility, I figure who cares? I'm a lot more concerned about my financial net worth. If my Dendreon and Cortex gambits work out, I'll hopefully be off these boards forever, and laying on some tropical beach. If I owned upwards of 1% of GTCB like you do, I'd sell it and do just that.
Uranium (3-07) - Big Squeeze for Uranium
Tuesday, March 27, 2007
>>> Big Squeeze for Uranium Demand fast outstripping uranium supplies.
The price of uranium has risen 810% in the past four years according to Keith Kohl of the newsletter, Energy and Capital. On Friday TradeTech's Nuclear Market Review magazine raised the weekly spot uranium price to US$95/pound. Many analysts predict the price will explode past the $100 mark this year.
According to Kohl, "The emerging global energy crisis has thrown nuclear energy into the spotlight. While a few alternative energy sources are making headway, future global demand will require energy on a vast scale - something nuclear power can provide."
Uranium's bull run is a spectacular example of demand stampeding supply. According to Moneyweek.com, the world's 440 nuclear reactors require more than 150 million pounds of uranium every year. Although totals aren't in for 2006, "Demand probably topped 180 million pounds." There are 28 reactors under construction and 62 more being planned. According to the International Atomic Energy Agency, the IAEA, there may be as many as 130 new nuclear power plants being built in the next 15 years.
Cameco's (TSX: T.CCO, BullBoards) disastrous flooding at the world's largest undeveloped, high-grade uranium mine, its Cigar Lake Mine in Saskatchewan, rattled the nuclear power industry last fall. Then along came another mine flooding in Australia when cyclone George struck, putting a big squeeze on already tight uranium supplies. Energy Resources of Australia had to declare force majeure on its sales contracts. ERA estimates that first-quarter production will drop 20% to 30% from last year.
Doug Casey, author of Casey's Energy Speculator, sees another force at work pushing prices higher. "A number of money managers have been buying physical uranium in the hope of simply holding it while the price rises." Casey notes that although it is unclear how many groups actually own physical uranium, "… analysts generally agree that hedge fund demand has helped push up the price."
Unlike commodities such as gold or oil, there is no formal exchange for uranium. Uranium price indicators are developed by a small number of private business organizations, like The Ux Consulting Company, LLC (UxC), that independently monitor uranium market activities, including offers, bids, and transactions. UxC maintains that "the low prices that persisted through the 1990s up until 2002 held back production, exploration, and procurement activity, even though there was strong evidence early in this decade that the market was experiencing a fundamental shift that would lead to pressure on production and much higher prices."
_________
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The GOLD Report is Copyright © 2007 by Streetwise Inc. All rights are reserved. Streetwise Inc. hereby grants an unrestricted license to use or disseminate this copyrighted material only in whole (and always including this disclaimer), but never in part. The GOLD Report does not render investment advice and does not endorse or recommend the business, products, services or securities of any company mentioned in this report. From time to time, Streetwise Inc. directors, officers, employees or members of their families may have a long or short position in securities mentioned and may make purchases and/or sales of those securities in the open market or otherwise. Streetwise Inc. does not guarantee the accuracy or thoroughness of the information reported. <<<
Lumpy, I've seen various estimates, but do we have any reliable figures for the level of short interest just prior to the FDA panel decision compared to the level now? Thanks.
Walldiver, board, Do we have a reasonably accurate figure for the level of short interest just prior to the FDA panel meeting last week compared to the current level? Thanks.
Dew, I'm just trying to make some money like everyone else around here :o) After a year of bio abstinence, I came to the realization that working/saving and CDs weren't going to get me there, so I was in a major funk as to what to do (plus I had lost my job in January, adding to the quandary and general level of desperation. Luckily I'm working again, but the experience forced me to reevaluate everything).
Prior to the Roth conference, where Dr. Stoll announced the totally clean electron microscope data, I really thought CX-717 was a goner. The Roth revelations, plus my own realization that I had to take bold action in order to turn around my sinking fortunes, led me to get back into Cortex (unfortunately it took over a month to get my funds in place and available, so I missed the easy part of the Cortex runup). Then I saw the Cortex timeline slipping, from mid-April, to mid-May, to mid-June, etc. So I looked around for an alternative high impact event to hop on in the interim, an lo and behold the Dendreon situation presented itself, and though I had missed the initial move, some fast DD revealed that there should be considerably more upside, even before their mid-May decision. So out went the Cortex stock and in came Dendreon.
Whether or not I stay in Dendreon through their May event, or unload prior to it will likely depend on how far it has run up in the next several weeks (I bought a ton of the stock, relatively speaking). With the favorable FDA panel vote last week, it looks like there's an excellent chance for a clean approval (though some uncertainty remains), and there's a huge upside longer term, plus the potential for a buyout. There's also the potential for a short squeeze of massive proportions. Anyway, I don't see much happening with Cortex over the next couple months, so I'm going to roll with Dendreon for now and try to stay flexible.
Anyway, my behavior has seemed pretty bizarre lately, I'll be the first to admit it. This could turn out to be the last caper of an aging fool, or the main event toward rebuilding my finances, depending on the outcome. I'm not planning on making this type of risk taking a habit though. I've followed biotech long enough to know that good luck never lasts long around here. I've made a big enough wager so that if it works out, I can go back to more normal diversified investing, which is the approach I greatly prefer anyway. Anyway, that's my story.
BTW, my Dendreon post doesn't constitute "pumping" in the usual sense, since there's nothing I could possibly say that would affect the dynamics moving that stock. I'm enthusiastic about it, and merely wanted to get your opinion, which I value highly. You seem to have a stubborn tendency to decide about a company and then not budge, even if events may warrant a reevaluation. That's the ego coming through, which is understandable. But sometimes extreme nimbleness is required in this sector. Your own decision to own something like 5% of GTCB doesn't sound much more rational than my own admitedly peculiar behavior though does it? :o) FWIW, I think you're missing a big opportunity here with Dendreon, even if one just considers the pre-May 15th period. That stock is going to be in the mid-20s in the next several weeks. A short squeeze may also be a factor in the pre-May 15th period, and if a clean aproval comes as now appears likely, there's going to be a squeeze of monumental proportions. In that scenario, this stock could represent the "main event" in a bio investor's financial life. Of course the Cortex event in a few months has similar potential.
Preciouslife, Thanks for the links. And the new I-Hub "Toplists" feature also looks very useful :o)
Dew, Concerning Dendreon again, while there was some hyperbole by the author of that post from the I-Village board, his basic message seems to ring true. It's ironic, but I decided to load up on Dendreon on Thursday morning, just minutes before that Wall St "Captain" hit his buy button. Oh well, I guess sometimes it's more important to be lucky than good :o)
Dew, Yes, that's just a guesstimate, though it's widely known that the stock was extremely heavily shorted prior the the FDA panel meeting. Apparently the entire Wall St hedge crowd had this one dead wrong, and now they have to scramble bigtime to salvage what they can. There's even talk that some hedge funds might even go under from their Dendreon miscalculation. Here's some of the speculation concerning the extent of what's happening -
>>> The light bulb went off in someone's head on Wall Street on Thursday...
http://www.investorvillage.com/smbd.asp?mb=971&pt=msg&mn=67348
By: skcotswonki
The light bulb went off in someone's head on Wall Street on Thursday...
Someone on Wall Street took a careful look at DNDN on Thursday morning, and like the ship captain in the Poseidon Adventure they looked out and saw the coming tsunami and said "OH MY GOD, turn on those buy programs now, TURN THEM ON!"
Some of the shorts will go bankrupt and will be out of business before this is over.
Stocks are not supposed to do what DNDN did on Thursday, ever. The jump last Friday and the 92 million share day were predictable if Provenge received a strong endorsement from the advisory committee, which it did. Stocks that jump on news are supposed to see their volume decline about in half each of the next several trading days as the story runs out of legs and normal trading resumes. Volume in DNDN fell to 13 million shares on Wednesday. This is exactly what DNDN was doing until about one hour into trading on Thursday, then someone on Wall Street hit the panic buy button.
DNDN went on to trade 60 million shares on Thursday and climb almost 20% on no new news, no analyst upgrades, no events at all that should have caused the stock to trade more than 10 million shares on a get out of town day before the three day weekend.
Now, why has it taken a week for what is about to happen to soak in to someone' mind with access to the buy button on Wall Street? First, and remember this, this has never happened before in this way in the history of Wall Street. You have never had such a leveraged bet to the downside that was so incredibly stupid and wrong going into an event that has almost unlimited upside without the shorts, a chance to own some of the only 82 million shares in the world of the company with the biggest breakthrough in cancer since surgery and radiation. Second, and equally important, you have never had such corrupt and lopsided and wrong analysis passed off as research since probably the late 1920's. Hence, there is not a single research report someone on Wall Street can pick up and read and say WOW, Provenge is a $2 billion plus drug and DNDN is worth 5 to 20 times that $2 billion figure, discounted back for risk and time. That discounted value is triple digits in and of itself. The analysts were still out screaming in the press on Friday and Monday that the FDA would not approve what their advisory panel just voted overwhelmingly to approve, now that's corrupt.
On Thursday, when the buy button was hit on the buy program, it quickly took out an unprepared line of defense at $15.40. The shorts attempted to regroup at $15.88, $16, $16,72, and $17. All of these lines of defense were quickly over-run and the buying program marched straight to $18. This is where the shorts were able to regroup and throw everything they had to stop the wave. However, the only thing they have left to fight with is MORE NAKED SHORTING. So, at the end of the day, net-net, there may actually have been an increase in the short position because of the three hour and 40 million share fight Thursday afternoon to defend or breakthrough $18.
Now, if you have not fully comprehended what I have just written in setting the stage, then stop here and go back and re-read it before you move on to read about the coming Tsunami and the light bulb that went off in some Wall Street Captains head.
First, this person realized that the ASS (Ashcoff, Shenouda, & Sendek) team of analysts are lying. The FDA will 100% not keep Provenge off the market to run the 9902B study, that's right I said 100%. The only risk to approval by May is the CMC section (which is so far so good), or some excuse like working on the safety plan so that the FDA can approve Provenge subject to a 90 day delay which would really be about finishing enrollment in 9902B by mid summer. I give the odds of approval in May 98% and the odds of approval in 2007 99.98%. This Wall Street Captain knows approval of a billion dollar cancer drug in a now small cap company is only weeks away, maybe only days away.
Second, the stock is so heavily shorted that almost every brokerage firm on Wall Street has a negative imbalance (naked short) position. This means in a couple of days, if the brokerage firm does not come into balance by locating more shares to borrow or by buying back DNDN to close out the imbalance, then the brokerage firm can not sell more stock short without first having the shares borrowed in advance or having a stock certificate in advance. No more sell today and I will come up with my certificate or borrowed shares on Tuesday. It will all be C.O.D. for the short side. Now, it is a mistake to think the naked short position has to be covered next week, it does not. It is just that no new shorting in size can occur until DNDN comes off the Reg SHO list. The shorts have lost CNBC, their analyst henchmen have lost all credibility and will not be quoted with nonsense like no approval in any stories going forward, and it will keep seeping in on Wall Street that approval is in the bag and Provenge is a multi-billion dollar drug. My guess is over 30 million shares were still sold short at the close of business on Thursday.
Now, again, go back and re-read before moving forward if you didn't fully comprehend what was just written. The Provenge story is a triple digit story. Unwinding the short position in DNDN is a second triple digit story on its own.
There is a third independent triple digit story which is exploding now and will keep exploding over the next few weeks. The call options for April and May are going to be exercised en masse. Today, there are over 25 million April and May options to buy DNDN stock at $10 or less. Most of these deep in the money calls will be exercised and not sold and the market makers and call sellers must deliver over 20 million shares to the owners of these calls in the next few weeks. And because of Reg SHO they can not deliver phantom shares. This is no OSTK people, this is the biggest story on Wall Street and all eyes are on it. The SEC knows it and every compliance department knows it on the Street.
The fourth independent triple digit wave that may hit DNDN is all of the other call options that may soon be deep in the money for April and May followed by all of the August call options. There are over 8 million more April and May calls written at $12 1/2 and $15 that are now deep in the money and will be much deeper when this stock rolls into the mid 20's next week. There are over 5 million August calls that are deep in the money now.
DNDN was the second most active stock in the market on no news on Thursday. DNDN was the 6th largest gainer on no new news on Thursday. Some Wall Street Captain chose to hit the panic buy button on Thursday. Everyone on Wall Street will want to figure out just what the guy who hit the panic buy button knows come early Monday morning.
What he knows is economics 101, supply and demand. There is tremendous demand over the next several days and weeks for shares of DNDN and there are not nearly enough shares to satisfy demand. DNDN is right now in the early stages of hits parabolic run, not the late stages. There has never been three separate triple digit per share circumstance in one stock in the history of Wall Street before. Well, there is now baby, there is now. Forget the fundamentals, this is now all about froth and survival.
If you want to see $100 by May, then do not sell a single share next week. If you have margin, then move some of the DNDN shares that are no longer needed to support the margin account to the cash account (remember it is not an all or nothing proposition). If you own calls at $10 or less for April, then exercise them this week (you don't want to miss the big run and you don't want to pay ordinary gains anyway). If you can, buy more shares or start buying some of the November out of the money calls. The reason so many calls exist is because they are way to cheap and enticing. They will have to price the calls to a point where you think it is 50/50 to buy the calls or buy the stock, or the swelling call volume will not cease.
Everyone have a great Easter weekend and remember the heart of the Christian message is forgiveness. I believe the shorts will see enough punishment for there crimes and it will be so brutal no one with a memory will dare do what they did until the memory of this generation dies out. I am going to spend the weekend conditioning my heart to find compassion for the shorts. Lord knows they need it.
P.S. I do not have access to all of the different hedge fund agreements, but it could be that some of the hedge fund clients actually have liability if the hedge fund goes belly up. If you have a hedge fund find out if they have DNDN shares on the short side Monday morning and if they do, demand your money back immediately, while you still can. <<<
Dew, Just as an addendum, estimates are that Dendreon still had approx 30 mil shares short at the close of trading Thursday, and the stock has a float of only approx 80 mil shares. So that could make for an incredible squeeze as the stock continues to move higher over the coming weeks, even before the May 15th decision.
Thanks Dew. BTW, Just wondering if you've been reevaluating Dendreon in light of the new developments? I'm fairly new to the stock, and thus have had few preconceived notions about it one way or the other. At the very least though, it looks like a major short squeeze is in the offing. While no one can be 100% sure of the May 15th outcome, the FDA panel decision appears to have changed the dynamics for the stock immeasurably, or at least the odds now appear heavily skewed in its favor, as Feuerstein and other former critics now readily concede. You've said that bio investors need to be extremely nimble at times, so I'm curious if you're considering a reevaluation of the stock? Thanks for any insights.
Olympus, Yes, I've been figuring $20 early next week, a brief pullback to the $18 level, and then on to the mid $20s. Wall St is in the process of doing a major valuation rethink on this stock, in light of the recent excellent and unexpected news. The news seemed to take eveyone by surprise, and the valuation is just starting to get realigned to the new realities, those being that Provenge is going to be a $1 Bil+ blockbuster, with rapid acceptance, ramp up, with big label expansion/off label potential, plus the buyout scenario with multiple interested large Pharmas vying for the company. I bought into the stock with a short term trade in mind, but the longer term potential here looks increasingly compelling.
Aiming, Yes, I noticed that too >>> "and questions which we would like to have answered by the Agency" <<< I would have thought that the FDA would be the one asking the questions, so I'm not sure what Dr. Stoll was referring to.
OT, Speaking of "The Agency", as Dr. Stoll respectfully refers to the FDA, I had to laugh because my dad worked for years as an engineer for companies doing various covert projects for the CIA. He rarely talked about his work, but when he did he would occasionally use that same term - "The Agency".
Dew, Just wondering if you know of a good free site that lists the day's biggest percentage stock gainers/losers and related info in something approaching real time? You always seem to instantly have this, so I was wondering what were your favorite sources for this type info? I have approx 75 stocks on various Yahoo watch lists, but that only provides info on those particular companies, and I'm trying to find a way to cover the entire market. Thanks Dew.
Board, Any thoughts on the pre-May 15th upside here? I've been figuring the mid-high 20s, but am new to the stock. Anyone think it could realistically get into the $30s pre May 15th? Thanks.
Also, any ideas on the timing of a possible buyout, assuming a clean approval in May? The Abgenix buyout comes to mind, where it wasn't long after their big Pmab news that they got munched by Amgen. Would Gold & Co tend to be amenable or resistant to a buyout scenario? Thanks for any insights.
Concerning timeline slippage in biotech, I always thought the term "Instant Forever" seemed like an appropriate term. That was a phrase used by the comedian David Frye back in the late 60s/early 70s on one of his comedy albums. It was long before the biotech industry even existed, but seems like an apt description of both drug development and the regulatory process - Instant Forever :o)
Neuro, Just wondering if you've made an updated timeline estimate in light of Dr. Stoll's response to Ombow's email (see below). Here's my take based on the email -
1) The new data submission should be mailed to the FDA by approx April 12th.
2) After receipt of the data, in theory the FDA then has up to 60 days to respond to Cortex's request for a meeting. So 60 days moves us to mid-June to find out if the FDA will do a meeting.
3) If the FDA will do a meeting, it will need to be scheduled. How far off the meeting might be scheduled isn't clear, but let's say within 30 days. This moves us to mid-July for the date of the meeting.
4) After the meeting, the FDA will presumably then have 30 or 60 days to further ruminate and issue their decision based on what's been gleaned at the meeting. This presumably puts us at mid-August to mid-September to get their final verdict.
Does this sound like a realistic timeline estimate? Or perhaps the FDA might not feel the need for a formal meeting, and prefer a telephone call or email, and thus save several months? It sounds to me like the meeting is mainly Cortex's idea, probably at the suggestion of the consultants. Thanks Neuro for any comments.
>>> John, We are submitting the package with a request for a meeting and it is agreed that they need to see the data before they can commit to a meeting. In theory they have a sixty day clock within which they need to respond as to whether they will have a meeting or not. There is no way to know whether they will agree to meet, want to dialogue by email or phone, or whatever method of correspondence they choose ahead of a response from the division at the FDA. So to fully answer your question, we need to get an answer from the agency after the package is submitted along with the request for a meeting and questions which we would like to have answered by the Agency. We are currently waiting for the final written report from one of the toxicology studies from the CRO and when we get that it will be integrated into a final overview document which will cover the study reports which are being submitted. We hope to have this in the mail by the 12th, but that is assuming we will get the final report from the CRO by this Friday. If that slips a few days, our filing will obviously slip as well. The data is positive and there is no change in the company analysis of the data that the changes described in the previous toxicology studies occur postmortem and are driven by the fixation solution as it kills all the functions within the cell. Roger <<<
MarketFest, I'm figuring that with the various delays, the large amount of data, and the need for an FDA meeting, etc, the Cortex event could slip to around July. My problem now is that with Dendreon looking so good for the longer haul (and a likely buyout candidate if they get a clean approval), I may not want to unload it right away. In any event, hopefully the GFP "jinx" is over, and won't be messing up the karma for Cortex. Truth be told though, Cortex has had its own ample supply of bad karma over the years, without any help from me :o)
I've been noticing an interesting phenomenon associated with some of these binary type events, where there can be a good entry window right after the event. For Cortex it happened after Stoll's presentaion at Roth, and it just happened again with Dendreon. In both cases, the stocks were very undervalued just prior to the event for various reasons. For Dendreon, the expectations for the FDA panel meeting were low, and for Cortex the company and the presentation were fairly obscure, there wasn't an immediate press release, etc. Whatever the reason for the stocks being so cheap, in retrospect the potential was clearly there for a sustained multi-day post-event up move. Of course there are many other stock specific factors involved, but this seems like an interesting phenomenon worthy of some further study.