phoenix55218

Biotech: The Next Big Bubble?

You're truly a fool. Aschoff is not a physician. As a matter of fact, he was fined several years ago for falsely claiming to be an M.D. and trying to get information from physicians running clinical trials(Which is illegal). His firm has consistantly shorted Dendreon, so his motives are suspect, to say the least.
You're going to take advise from someone who commits fraud to try and illegally obtain clinical trial information before final results are released?
Try doing a little research on your souuces next time, unless he's paying you under the table.

Dendreon: The Provenge Approval Scandal, One Year Later

Ted, great summary of the misconduct that has occured over the past year. Many have gotten discouraged over the often slow and frequent lack of progress in the case, but, as in all things political, it requires a slow steady grind before anything is accomplished.
Best wishes.

Dendreon Suffers from Immature Management

I like that, you don't have time or space to explain why you think the interim results will not support approval. That does seem like a major omission.
As to your view on the involvement Congress, you are wildly off base. If it was a matter of Congress telling the FDA that Provenge was a great treatment and had to be approved, in essence rendering a medical opinion, then I would agree with you. Instead, it is a matter of holding hearings to see if the FDA's decision making process has been corrupted by outside interests with their own agenda. Dr. Scher comes to mind on this one.

Let's see, why shouldn't DNDN try for approval before 2010/11?
1)Well, another 60,000 men, roughly, will have died from AIPC between the interim results and then. That would influence me.
2)DNDN will have to finance at least one more time (Beyond the $130M financing they have locked up) ,further diluting the stock and delaying the advancement of their pipeline. If you know anyone who has ovarian or breast cancer (My mother has metastatic breast cancer), then this might be an important concern.

"Part of the hoopla"...that phrase kind of implies that the issues at stake are unimportant. Are you saying that patients dying early or needlessly is an unimportant issue?

You say that Provenge"would ultimately get approval in 2010 or 2011.", so it sounds as though you think Provenge is effective.
Why then are you not irate over the FDA's decision and hoping for either a reversal based on Congressional hearings or at least approval based on interim results?

Are you by chance looking to make money on the short side between now and 2011? Maybe that's why you don't offer an argument for not using interim data and why you don't comment on Dr. Scher's COI.

Just my thoughts, but what do I know, I'm just a physician who treats patients dying from AIPC.