Perhaps this Fordwill excerpt has caused some spec on an earlier peek:
>>Could it be that Doc Gold has played down the real significance of the 9902B trial so that the stock won't take off too soon?
Before anyone accuses me of pumping, schitzophrenia or something worse here's some wild conjecture.... You all might need to get the science experts in here to help us understand this by the end of next week....
1. Is the 9902B a traditional stand alone trial or not?
I argue the latter. It is no longer a traditional trial. It has one purpose only. It is to show that Provenge is efficacious like 9901. It is to merely show support. As a logical extension to this thinking... throw out the Alpha spending. Who cares if the P= .025 or .05? All we care about "does the data support 9901 or not?" That is, does Provenge provide significant life extending capability by stimulating a patience's immune system to fight prostate cancer?
Here's what I'm thinking... If the rate of death in the untreated arms is sufficiently higher than the treated arms, and Dendreon can claim anything close to the 3x survival advantage at the end of 36 months by using Provenge, then it is a slam dunk.
But Ford, we're are talking about the "interim look"....
2. Go to the DNDN website and check out the 9901 slide that had the Kaplan/Meier curves on it. It starts showing separation between the treated arm and the placebo about the 14th month.
If Gold can get similiar tracking with 9902B, could he not also be able to then argue that 9902B is new, additional data showing efficacy? And if so, could he then argue for an approvable letter with rights to immediately launch to market Provenge on the condition that DNDN continue to track the death rate between the 2 groups?
3. Where's the critical 14th month with respect to the 9902B patients? Well, that's a messy question because the data is really spread out due to the slow enrollment for the trial. My personal guess that they already have quite a few deaths in hand but may not know if they are from the placebo arm or treated arm.
4. Could not then we have a pattern here that far speeds up the process? We toss the Alpha comparison and only look to survival as a simple question... is 9902B supportive of 9901?
5. Mitch made a rather mysterious/cryptic comment about the number of rated deaths that needed to occur for them to respond to the CR Letter. Certainly someone has that worked out. 320 deaths? 280 deaths? or? But, would he not argue to upgrade the CR Letter to an Approvable Letter with rights to market if the survival stats show an indication of support? My investment bet says he will.
Here's somethings we need to really understand to force this hypothesis onto firm land....
1. Is a supportive trial all that's needed? No formal log test. Only a score of survival months?
2. If DNDN writes up such data, does not the FDA have another 6 months to review the latest info in light of their current BLA?
3. Would DNDN choose to rewrite their entire BLA with 9902B data replacing the 9902A data under the 9902B SPA guidelines?
All of these questions beg a detailed answer.
My own personal bias is that we are a lot closer than we think we are because we don't have to go through a ton of hoopla here. With the political pressure in place, the FDA wants this done yesterday and put to bed once and for all. They'd love to blunt the Abrigail lawsuit with a Provenge conditional approval...
So, could we begin to see enough separation with a lionshare of the data as early as November this year with a 6 month review puts an FDA response into May 2008????
Could it be?????
Fordwill1953<<
I have a hard time going with this = I thought that DNDN had already lined up behind a mid 2008 peel. sam
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