Well, thanks to all for the kind words. I was able to sell all of my April $10 calls for a huge return a few weeks ago. Today, I decided I had to sell my entire common stock position early this morning in premarket. I was on margin but not excessively so, the main cause of my going on margin was my exercise of a ton of April $7.5 calls. The cost basis of buying those calls, plus purchasing the stock at $7.50, caused me to break even on that trade when I sold today. I was able to make about a 75% profit on all of my other long shares. In hindsight, I should have sold about 20% of my long shares at the top of the short squeeze, which was roughly the same time I sold my $10 calls. I'm kicking myself over that...I wasn't expecting the FDA to make the unprecedented decision of overruling a positive advisory committee vote in a terminal disease indication. A lot of my holding on was the desire to not pay the 38% federal income tax (same rate as highest tax bracket, not the 30% short-term capital gains rate) and 9% California capital gains tax. All of these trades together, including my sale this morning, approximately quadrupled my DNDN investment from late March.
I had previously sold out of my position with the expectation of buying back in the day of the briefing document release (I expected to see negative briefing docs, not the neutral one that it ended up being), so all of my trades in the past month were of the short-term variety.
As a conference call has been scheduled very quickly, it appears to me that DNDN will take a conventional approach to resolving the Complete Response letter, and that will be to wait for interim survival data in 2H 2008. I don't think they will try to unblind sometime in the next few months, as I don't think CBER would grant them a statistical penalty-free look.
Again, as I said on the I-Village board, I think the biggest influence in CBER's overrule of the advisory panel was Dr. Fleming's letter. I think CBER was inclined to approve all the way up to that point, as I personally know of approximately 15 oncologists or urologists who emailed the FDA in support of approval, and almost every major prostate cancer advocacy group in the country also made their desire for approval known to the FDA. However, Fleming basically threatened Dr. Marincola with medical malpractice liability for wanting to use HRPC patients as guinea pigs for the greater God of wanting to open up venture capital funding for immunotherapeutics by approving Provenge. There were other statements that Dr. Marincola made during the advisory panel meeting that prove Dr. Fleming was taking his "funding" quote out of context, but nevertheless Fleming's words struck fear into the heart of CBER. I think they knew that if they approved Provenge and 9902B later missed the survival endpoint, their jobs would be toast. They would either be fired or transferred to CDER, under the auspices of Dr. Pazdur. The latter of course would be a worse fate than being fired...so they caved in. The ironic thing is that if 9902B comes out stat sig, CDER will probably look down its nose at CBER even more, because it didn't stand up to the political pressure. Dr. Von Eschenbach obviously caved in too, and all of his words at the February FDA/NCI immunotherapy conference now ring hollow.
I think it's obvious that the hedge funds used all of their oncologist and biostatistician contacts at their disposal, and probably were at the forefront of the organized effort to derail the Provenge BLA...no conspiracy, just the same lobbying effort that was a mirror image of the lobbying effort made by DNDN retail longs and PCa advocacy groups...except the hedge funds had bigger guns at their disposal (president of ASCO, Fleming, Scher, Hussain, and The Cancer Letter). Who cares about terminal patients, anyway?
Best of luck to all...I'll post a link to this post over on I-Village, which will probably be my last post over there for awhile. Too many posts to wade through over there.
