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DNDN - I think a couple analysts are starting to agree with that view. I don't think there is any "competitive" reason to withold the IMPACT enrollment figures, or the p value interim look allocation, or the exact number of events for the interim look. All three should be disclosed, IMO.
I own JAV but no longer own REGN. There are always going to be trading opportunities if you time it right, but I think that clinically, REGN has a tough uphill climb ahead of it...so I prefer to invest my money elsewhere.
Not much happening right now on the clinical front. I imagine there will be some fireworks on tomorrow's conference call, though. Management is probably not looking forward to some of the questions (SEC investigation, 483 issue, trial enrollment, pipeline, etc).
Thanks...I can't see the company not reporting both numbers this time. They can't be that dumb. If both sets of numbers are reported initially, and there is an early downdraft due to some mo-mo players trading on a negative headline without reading the actual story, I could foresee a quick recovery in the price, with that initial drop being a good buying opportunity.
Most of the earnings releases that I see are reported in such a way that the first set of numbers you get are the actual earnings, and the second set are the earnings ex-one time items.
re CORT
Yes I have a position...and no idea if a partnership/buyout is near.
I'm following REGN but I haven't gotten back in. I don't know if I'm going to, as there are some much bigger bargains out there, IMO.
BSR covers a number of companies that fall into the category of those bios that could do well in this environment.
Some great bargains in biotech land these days. JAV under $4, PDLI back under 23, CORT back to 2, SNUS back under 5, RPRX back under 13, ALTU in the 9's, FOLD down to 11, OPTR approaching 9 again, SGEN under 9 for the first time in awhile...
Anyway, Dew, you must have lived here in the late '70s or early '80s, or even before. The smog isn't nearly as bad in LA now, thanks to Calif's stringent air emissions laws. The heat, on the other hand, ugh.
Is Healthcare No Longer Investable?
David Miller Aug 03, 2007 1:34 pm
Biopharma is done. Big pharma has been done for years. There might be some love still to be found in the generic space...
http://www.minyanville.com/articles/DNDN-prescription-drug-biotech-pharma-ALTH-GPCB/index/a/13558
As we move to the final stages of the Prescription Drug User Fee Act (PDUFA) renewal and accelerate into the Presidential election season, it’s a question I have to ask.
So I don’t bury the lead, my general conclusion to the question of whether you can invest in healthcare (from the long side), is "no" with two exceptions:
1. The next two years for most any development-stage biotech company, driven by acquisitions.
2. Early-phase development-stage companies who have market caps below $100 mln and who are just entering into meaningful Phase II trials.
Biopharma is done. Big pharma has been done for years. There might be some love still to be found in the generic space, but those trades have been crowded for some time and they will get even more crowded as the Democrat candidates start ramping up their drug cost diatribes.
I’m aware it’s popular right now to be flogging big-cap pharma and biopharma as great “undervalued” investments. Their pipelines are pathetic and $40 bln in sales (~20% of the $230 bln in total sector sales) will go off patent in 2009, creating huge holes in the balance sheets of the sector.
Because the price of a stock and the value of a company are only coincidentally related, it is possible to make money on big-cap biopharma and pharma. If you go long these time bombs, realize you’re simply one more lemming in a sea of lemmings headed for the proverbial cliff. Since “lemming money” spends the same as “smart money”, that’s OK as long as you know where the cliff is and decline to follow your fellow lemmings over the edge.
While this might sound like a boon for the short-side guys, it isn’t. After three years of shooting fish in a barrel, biotech has become heavily shorted enough that the risk/reward on binary events is starting to become more balanced. I’ve noted frequently over the last three years that risk/reward in biotech has become unbalanced. Good binary data causes a 20-30% jump while bad binary data causes a 50-70% decline. That disparity is icing on the cake for short sellers who are already benefiting from a 90% failure rate among biotech companies.
But just in the last few quarters, that disparity is closing. More than a few good binary events have seen stocks jump 100-300% with no appreciable pullback. In June, we saw a complete failure of Allos Therapeutics' (ALTH) Efaproxin, the company’s lead drug, and the stock essentially didn’t move. That hurts bad if you’re short.
Toxic Regulatory Environment
I believe that at this point no first-in-class lifestyle drug will get first pass approval in front of this FDA. I also believe that no same-class (second-to-market or later) drug in a blockbuster class that has demonstrated some safety concerns to the FDA will get first-pass approval absent very, very large clinical trials directed specifically at any worrisome side effects. Even then, as demonstrated in the COX-2 space, your chances are iffy.
As I’ve been saying since 2004, and I’ve seen in a series of editorials and other communications from a broader group of advocates, executives, and doctors recently, oncology drug approvals seem especially broken.
Take the example of two recent prostate cancer drug approvals. In May, the FDA turned down Dendreon’s (DNDN) Provenge because the drug did not meet a surrogate primary endpoint, even though it showed an advantage on a secondary endpoint of survival. In July, the FDA (ODAC) turned back GPC Biotech’s (GPCB) Satraplatin because it has not shown an advantage on a secondary endpoint of survival, even though it met a surrogate primary endpoint.
Avoid At All Costs
There are investments that must be avoided as the items above come to pass. I should emphasize that there may well be money to be made on a few of these, but the risk on each is already markedly higher than it was even a year ago. If your investing focus is largely in these areas, you need to be especially concerned, regardless of how well you’ve done in the past, because you need to expand your strategies elsewhere – sometimes not an easy thing to do.
Late-Stage Lifestyle Drugs
Lifestyle drugs may face difficulties. 20 patients out of 5000 may be considered an adequate “safety signal” to negate an approval or trigger post-approval safety surveys. I want nothing to do with this now and I believe it will get worse going forward.
Late-Stage First-in-Class
Is the company bringing a first-in-class drug to the FDA? This may be difficult, particularly if the drug represents a paradigm shift in the established treatment for the disease. It will require an advisory panel, which means anything can happen. With the FDA often, it seems, overruling its advisory panels these days, even a positive vote from the assembled experts doesn’t mean the drug has a free path to approval.
Recognize that sometimes first-in-class is not paradigm-shifting. Let’s say someone discovers a rainforest plant whose sap is the next chemotherapy drug (like the taxanes that were birthed from the Pacific Yew). While it may be first in class, this would not be a paradigm-shifting drug.
To determine the difference, ask yourself if the new drug:
Markedly changes who in the healthcare community treats the patients
Significantly alters the economics of treating the patient
May encounter resistance from a substantial number of key thought leaders in the disease
If one or more of these, you likely have a paradigm-shifting drug and you need to be very, very careful because your risk just went up significantly.
Biosimilar Producers
With the 12-year exclusivity written into the proposed PDUFA legislation, don’t bother. If you do bother, realize you are investing in a pack driven by perception and not fundamentals. Be nimble and don’t get greedy.
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Position in DNDN
IMO, the uncertain patent/political/judicial climate is pulling downward on the IDCC stock price to a lesser extent than the subprime mess is. Tech companies for the most part have been reporting healthy income, and are fairly optimistic going forward. However, it looks like some hedge funds and other large financial institutions are having to sell almost everything in their portfolio (including tech and biotech) in order to meet maintenance calls. This thing is spreading well beyond the subprime lenders and the regular lenders, and it's going to get worse.
One other entity that bears much responsibility for this mess is the Federal Reserve. A few years ago, Greenspan famously told prospective home buyers to go for adjustable-rate mortgages with low introductory teaser rates, then he and his Fed colleagues raised interest rates 17 times. Oops.
<<Financial services - does anyone think these big financial service companies like Bear Sterns are having to liquidate their biotech holdings and thats whats crushing the stock prices?>>
It's possible that's the case. It's also possible that the bios are getting sold BECAUSE people are anticipating that the institutions will need to sell some of their bios. Combine these two factors with the hostile FDA climate and the old axiom to sell your biotechs after ASCO and you get some pretty strong downward pull on the bio stock prices.
OT-AMGN isn't in the San Fernando Valley. It's in the city of Thousand Oaks in the Conejo Valley...in addition, the SF Valley isn't known as the "Armpit of the Pacific." That would be the major cities of the San Joaquin Valley, namely Bakersfield and Fresno. Anyway, Southie, you can't be home to half of the entertainment figures in LA and be known as an armpit )
PS-the Celtics will go only as far as Doc Rivers will take them
I'm not familiar with the target number of patients for enrollment in the Phase 3, nor the enrollment progress. You might have to scour through the NOVC website and a bunch of their conference calls to find out.
Could be related to yesterday's filing of the lawsuit
I've had to delete one post tonight, and there have been a couple others that approach my line of tolerance. I'd prefer to see the posters on this board who disagree with certain posts to disagree with the message, and not make personal attacks on the messenger.
The biggest key to this lawsuit will be if it's allowed to go into the discovery phase. Some interesting tidbits could then be shoved out into the open. These tidbits could bite the FDA in the keister, or bite DNDN mgmt (potential 483 issue, or potential for written negative feedback from the FDA). For that reason, I would come down in favor of filing the lawsuit. I would like to see testimony and other evidence about why the decision was made to deny approval. I don't have a legal background and some of the assertions made in the filing are outrageous. However, I'd like to know if these assertions are actually outrageously true.
Obviously, the greatest downside risk would be FDA retaliation against the company, which is a possibility even though the company has nothing to do with the lawsuit.
I think Provenge stands a better chance of statistical significance at the final look than Asentar does. It's hard to say which one has a better chance at the interim. Much depends on the allocation of the p values for the interims and final looks of the two trials.
As for approval, and assuming that both treatments attain strong statistical significance of p=0.01 or better for survival, I think the odds of approval will be slightly better for Asentar, although the odds of approval will be high for both. The research/clinical genitourinary oncologists are lined up behind Asentar to a much greater extent than Provenge, since it's being combined with Taxotere chemotherapy.
Even if Provenge hits stat sig in the 9902B trial, there will probably be an element both inside the FDA (OOD/CDER/Pazdur) and in the research/academic genitourinary oncology community that won't want to see it approved, as much of the primary care for HRPC patients will revert back to urologists...but I don't think the patient advocacy groups would let Pazdur get away with blocking it this time.
<<With 500 patients the 9902B trial should be well balanced.>>
Agreed.
<<Questions:
1) Assuming a perfect balance between trial arms for all prognostic factors, does the Cox regression extend any additional statistical power? Or would it yield exactly the same p-value as for the log-rank test? Are we banking too much on the ability of the Cox model to deliver stat sig results at the interim?>>
With the larger trial and presumably better balanced trial arms, Cox regression should still help eliminate some of the noise, but to a much lesser extent than 9902A or even 9901. I think the trial arms were also stratified at enrollment for # of bone mets, so that would be factored in as well.
<<2) The 9901 trial did not show a stat sig survival advantage until three years after the final patient was enrolled. At the interim look for 9902B, how many patients will have been enrolled for at least 3 years?>>
I'm guessing that there were 99 patients enrolled by Feb 2005, and we know that 179 were enrolled by Feb 2006, 294 by Nov 06, and 400 by March 07. We'll have to extrapolate from there, depending on when the assumed 180th death occurs.
<<3) The patients in 9902B will be followed until death not for just 3 years as in 9901 and 9902A. This means that a patient, like Ed Garcia, who lives many years would be counted as living for all those extra months. Not merely the 3 years. Eight of the 9901 treatment arm survivor died after the completion of the 3 year followup. How long was their overall survival? What is the total survival of the 20 men who are still with us? And what about the cross-overs and placeboes? Are they still alive?>>
We only know that 8 survivors out of the original 28 survivors in 9901 died after they survived the 36-month cutoff point. For the remaining 20, it's quite possible that all of them survived through March 2007, meaning that they lived for 5.5 to 7 years after randomization. The fate of the 5 survivors out of the 45 in the control arm is not known. Only one of these five was a non-crossover.
<<4) What is the PAP immune respsone index for these 9901 survivors after all these years?>>
I don't know
<<5) What are the DNDN R&D scientists doing on a daily basis right now? They aren't involved in the trials or in the manufacture of Provenge for the trials. Is DNDN obligated to shareholders disclose specific R&D activity?>>
I'd like to know this too.
<<6) These guys with GS>=8 had some pretty aggressive tumors but still showed a enormous survival advantage over placebo. 9901 showed a stat sig effect on TTP only for GS<=7. The TTP curve for GS>=8 overlapped. Is this still further proof that the TTP endpoint is biased against Provenge?>>
I wouldn't call it biased against Provenge, I'd call it a poor way to measure the efficacy of an immunotherapy against cancer.
<<7) Provenge isn't toxic to tumor cells and isn't supposed to be. Did the AC and do analysts really understand this point?>>
Not sure how to answer this question
<<8) All but 1 out of 20 control patient with GS>=8 was alive after 3 years versus 32% (10/32) of Provenge treated patients. Why didn't DNDN point this out at the AC? Why doesn't someone familiarize these analysts and journalists with this GS survival breakdown?>>
DNDN didn't do a great job at the AC. There were a number of factors that I would call persuasive that the company left out of the committee presentation and apparently the BLA package, this being just one of them. I agree that on this issue, and on the crossover issue, not enough analysts and journalists have been persuasively educated by the company.
% 3-year survival breakout by Gleason Score: 9901
GS<=6 Provenge arm: 41% or 9/22
GS<=6 placebo arm: 28.6% or 2/7
-----------------------------------------------
GS = 7 Provenge arm: 32.1% or 9/28
GS = 7 placebo arm: 11.1% or 2/18
-----------------------------------------------
GS = 8 Provenge arm: 40% or 4/10
GS = 8 placebo arm: 12.5% or 1/8
-----------------------------------------------
GS>=9 Provenge arm: 27.3% or 6/22
GS>=9 placebo arm: 0% or 0/12
<<Note: Could someone find the original source of these data? Not the original IV post. That's where I got it.
These data suggest that the treatment advantage increases with GS.
For GS<=7 18/50 alive with Provenge and 4/25 for control.
For GS>=8 10/32 alive with Provenge and 1/20 for control.>>
Wolfeman, the original source for this data was a slide at the Feb 2005 ASCO Prostate Cancer Symposium. I don't know where it would still be online. Perhaps there is another table in the FDA briefing docs for the March 2007 meeting.
Additionally,
PC specific survival analysis was strongly in favor of the treament.
Sensitivity analyses checking for trial arm imbalances based on prognostic factors confirmed that the results were stat sig.
<<F_cking 9902A. What is the explanation for the poor stat results and lower survival times for 9902A? Without a reasonable explanation the 9901 results are unverified leading to much uncertainty. That's why the FDA didn't approve. Not some conspiracy theory. With 500 patients the 9902B trial should be well balanced.>>
The patients in 9902A were sicker as a whole than the patients in 9901, especially concerning the # of brain metastases. The 9902A trial was not the main factor considered by the FDA in not approving Provenge. There was comparatively little mention of it in the FDA briefing docs, and CBER went along with DNDN's contention that 9902A, being unfinished in both # of patients and # of Provenge infusions per patient, should be seen merely as a supportive proof-of-concept trial. The June issue of BSR closely examined what I believe was the likeliest explanation for the CBER decision (I'm giving it about a 75% chance), with the Form 483 issue the other possibility.
The biotech indices didn't go down as much as the overall market did, and Dendreon has a "cult" following now, and is just not trading like it did from late 2004 to early 2007.
<<I believe the cutoff for interim survival was 6/15/06. At that point there were 112 patients left in active in the study. The breakdown was 90-22 which is much higher than the 2:1 randomization enrollment ratio.>>
I don't think those numbers work, as 463 deaths occurred by that date, and 950 patients enrolled in the trial. [Edit: unless you're saying those numbers are the # of patients still receiving satra or placebo]
I just checked the briefing docs, and I think the 700th death will depend on how back-end loaded the enrollment was. The last patient was enrolled in January 2006, and the median survival at the interim was about 61 weeks satra vs 57 weeks control. I think we'll see the 700th death this year, but perhaps GPCB will try a desperation move and tell the FDA the final unblinding will occur at a higher number of deaths, perhaps 800. Otherwise, I can't see it coming back stat sig at the 700th death. At 463 events, Cox p value was 0.296 and log rank 0.388, with the HR being 0.90.
It sounds like 12-month followup after the 700th death is merely a different desperation method of trying to improve the final p value, instead of just increasing the event trigger to 800 or more.
I don't know what the p value or HR will need to be for satra to hit stat sig. I would imagine that the p value would need to be 0.04-0.05. I think the interim overall survival p value based on the ~440 deaths was in the 0.25-0.30 range...would hope someone more familiar with GPCB/SPPI could confirm this, and also the approx date for that 440th death. I don't think it will be stat sig, but you never know. There could be some surviving outliers in the satra arm who end up forming a long tail on the curve, which looks like the only chance it has to attain stat sig.
It's stunning, I agree. A lot of focus is on the median PFS, which is statistically significant but not clinically significant. However, once you get toward the PFS at the 65 and 75 percentiles, satra was quite significant clinically. On the other hand, the FDA is clearly not happy that GPCB has been claiming the whole time that GPCB met its obligations concerning the signed SPA. Including the pain metric in the PFS endpoint, plus using the PFS endpoint in the first place, was a no-no.
Fall 2007 and "toward the end of 2007" can technically be defined as the same thing. I suspect that the Fall 2007 timeline was adopted and frequently mentioned by GPCB because it allowed for wiggle room. The FDA briefing docs stating "toward the end of 2007" narrowed it down further. If the data is released on December 20, then both predictions would be true.
SPPI/GPCB unanimous wait for survival data...no AA...walldiver egg on face
Blade, re satra, without taking into account the Pazdur political factor, I would estimate that it's a slightly better than 50-50 chance of a positive panel vote. Seeing as how I believe that Pazdur will steer the discussion toward a positive view of satra, I think it's about a 70% chance of a thumbs up vote. The guy loves real big chemo trials like the satra Phase 3 and the drug is fairly effective with severe side effects...right up Pazdur's alley. Even if it's a thumbs down panel vote, I still think it gets approved.
Back to my DNDN strategy a couple months ago, I can't PM you as I'm not a paid member. I did take about 15-20% of my total DNDN position off the table after the panel meeting by selling all of my $10 calls instead of exercising some. My entire DNDN position was a short-term one, as I had sold out completely prior to the briefing doc release and bought back in on the day of the release and the next day. Taking more off the table would have left more of the position subject to a nearly 50% total tax rate. If my position had been a long-term one, I would have taken about 1/3 of my total position off the table. In addition, every hint from CBER prior to May 8-9 was positive toward Provenge, including the huge smiles on the faces of Witten, Goodman, and the rest of the CBER staff immediately after the 13-4 panel vote. The FDA had also never gone against a positive panel vote in a terminal disease.
<<The runway may have had additional slick spots from left from tire skid marks from plane wheels, as they don't start rotating until they hit the runway (in case any of you notice the puffs of smoke from wheels as planes land.)>>
I've also read that one of the important componenets of a plane's braking system doesn't kick in until the tires begin to rotate, meaning that if the plane is hydroplaning on a slick runway, this component doesn't kick in, and the plane can't slow down.
blade re DNDN briefing docs:
The conclusion in the FDA's briefing docs were actually quite favorable to DNDN, stating that all things considered, it appeared that the chances of the survival benefit achieved in 9901 being a false positive could not be 1 in 1600 (because not primary endpoint), but instead could be estimated as closer to 1 in 40. Also in the conclusion was the statement that all of the other endpoints in the two trials, while not stat sig, trended favorably in Provenge's direction. The stock price reaction the day the docs came out was a gain of approximately 8-15% as I recall.
The relative favorability of the FDA statistician's briefing docs toward Provenge was one of the factors in my decision to load up prior to the panel meeting, and hold all of my common through the final decision. It appeared that despite all of the biostatistical rules that were broken in the Provenge BLA, CBER was favorably inclined to approve. They could have savaged the application along the lines of what was done to the applications of DORB, ALTH, ABT's Xinlay, and IDMI...but they didn't.
Has there ever been a better/cheaper buyout of a biotech company than Gilead's buyout of Triangle (VIRS)? I had just completed my due diligence on VIRS (I had thought it was too good to be true, so I spent some time trying to dig up more info) and was going to buy it the next morning, and GILD beat me to it.
re SPPI, GPCB, PHMN: Agreed, I think Pazdur wants a public forum to show prostate cancer patients he's really a good guy. It reminds me of the deal that was offered Yossarian at the end of Catch-22, where he could stop flying the missions and go back to the USA, and all he had to do, according to Colonel Korn and Colonel Cathcart, was "like us."
Yossarian = PCa patients
Come to think of it, Pazdur resembles Col. Korn (played by Buck Henry).
Anyway, I think satraplatin will pass ODAC easily.
re CEGE's VITAL-2 trial: did you get that complete enrollment by the end of the year info from a recent CEGE conference call? CEGE mgmt has always overpromised and underdelivered about the enrollment rates of both VITAL-1 and VITAL-2. Sometime last year, CEGE even said that they were focusing their resources on completing VITAL-1 enrollment at the expense of VITAL-2, which was rumored to be enrolling at a trickle.
The VITAL-2 trial design has always had the best chance of succeeding, IMO. I give VITAL-1 only a 5-10% chance of hitting stat sig, and certainly not on the first interim look. In fact, I think it's likely that VITAL-1 will be stopped for futility on the first interim look.
Granted, that's an error on the Seeking Alpha contributor's part. However, as the company with this AMD drug is rather obscure, it's not nearly as egregious an error as Lawler's comically uninformed comments about Tarceva and Erbitux. OSIP and IMCL aren't exactly unknown companies. Tarceva fails the NSCLC Phase III combo trial with chemo, succeeds in the NSCLC Phase III monotherapy, and Lawler is surprised that Erbitux failed its Phase III combo with chemo in NSCLC, because Tarceva is already approved for NSCLC and they are both EGFR-targeting compounds? Luckily for my laptop, I had put my coffee aside right before I read the MF piece.
Motley Fool article on IMCL...let's play FIND THE MORONIC STATEMENTS from Lawler. I'll start with, "The failed study does come as some surprise, though, because another epidermal growth factor receptor (EGFR)-targeting compound like OSI Pharmaceuticals' (Nasdaq: OSIP) Tarceva has shown effectiveness in treating NSCLC."
Slight Setback for ImClone
By Brian Lawler July 16, 2007
The results of cancer studies with targeted therapies often produce results that are a mixed bag, as ImClone Systems (Nasdaq: IMCL) is proving. Last week the drugmaker announced that its only marketed compound, Erbitux, failed in phase 3 testing to prolong progression-free survival for patients with non-small cell lung cancer (NSCLC). Erbitux is already approved for colorectal cancer and head and neck cancer and is in testing for other oncology indications.
The announcement of the failed lung cancer trial does not signal the end of ImClone's hopes to get Erbitux approved to treat this difficult cancer. ImClone currently has other studies in NSCLC underway. It's always tough to achieve solid results in metastatic (spreading) cancers, and failure in one study does not always preclude success in another study in the same indication with different drug combinations or patient groups.
The failed study does come as some surprise, though, because another epidermal growth factor receptor (EGFR)-targeting compound like OSI Pharmaceuticals' (Nasdaq: OSIP) Tarceva has shown effectiveness in treating NSCLC.
Other approved cancer compounds with different molecular targets such as Genentech's (NYSE: DNA) Avastin and Onyx's (Nasdaq: ONXX) and Bayer's (NYSE: BAY) Nexavar are also in testing as treatments for NSCLC, so Erbitux is not without competitors in this space.
Investors who waited to see the positive ASCO Erbitux colorectal cancer data before buying shares of ImClone -- but were put off by the stock jumping above $47 a share in May -- have finally received the discount on shares that they have been waiting for, with shares now more than 25% lower from that 52-week high. This failed clinical trial is definitely not good news, but neither does it signal Erbitux's failure in this growing and lucrative cancer treatment space.
I would imagine that the time DNDN initiates a compassionate use program would be the period after positive interim 9902B results and prior to FDA approval (or between positive final results and approval). I don't think the company wants to run a concurrent Phase 3 trial and compassionate use program.
As for the ad, I provided a very small amount of advice for the organizers, but that was it. The one realistic result of the ad that I'd like to see would be for someone to investigate Howard Scher's obvious conflict of interest issues. When you chair the scientific advisory board of a competitor that is showering money on your employer, you shouldn't be a voting member of an FDA advisory committee that is reviewing a product that would compete with your benefactor's...and when the panel vote goes against you, you shouldn't be able to influence the final decision-making process with disingenuous letters to the FDA that you know will be leaked.
<<The p values quoted in the advertisement sound impressive, but the advertisement does not mention that they had to do post hoc analysis of a subset of the data in a relatively small number of patients in order to find this number.>>
I'm not sure where you're getting the information on this particular issue. At the time the two Phase 3 trials began, it was agreed that for each patient, the primary endpoint was going to be time to progression, the secondary was going to be time to pain, and survival was going to be followed for three years. Because 9902A was stopped prior to full enrollment, and not every participating patient received the full course of Provenge, the basis of the filing was the 9901 trial, with 9902A providing supportive evidence. All of the survival data submitted to the FDA was for the intent to treat group. No subset data there.
Well, I guess we'll have to agree to disagree on this one. I read that same alert and came to the opposite conclusion, selling approximately 20% of my position (all of my $10 calls instead of exercising some). BSR devoted four pages to the insider selling, and stated that shareholders following Gold and selling some of their shares was the only rational thing to do, and sticking with your same position wasn't.
In hindsight, I wish I had sold about 1/3 of my common, but I was going on precedent. The FDA had never reversed a positive panel vote in a terminal disease before.
Anyone who subscribes to BSR knows that David didn't dismiss DNDN's insider selling as inconsequential at the time, or after.
I would imagine he was no longer considered an insider. He probably lightened up after the panel meeting, as those shares he was holding would have been long-term shares for capital gains purposes. It was a dark day at Dendreon when he left.
The protocol described in that article doesn't sound like either VITAL-1 (GVAX vs Taxotere) or VITAL-2 (GVAX+Tax vs Tax alone). Perhaps the reporter described it wrong, or perhaps CEGE is running a trial that's off the radar. As for the injections, it's anywhere from 4 to 16, depending on the patient.