Biotech Values

[poorgradstudent]

>Would the CU program be closed to people who quit the trial?<

My feeling is that the design of 02B makes this not too important. Since the patients aren't *required* to crossover, dictating whether or not they are allowed to enter CU rather than crossing over into the follow-up arm of 02B isn't a factor imo.

>Is it ethical for the company to treat men who have not enrolled in the trial better than men who have not?<

Could you clarify this? There is an extra "not", but i can't tell which one.

>So if the FDA is really worried about approval invalidating the results of 9902B, why wouldn't an althernative be, approval conditional on full approval plus, say, 6 months. Conditioning approval on the RESULTS of 9902B (i.e., till 2010) does not seem justified by a desire to maintain the statistical purity of 9902B, such as it is. <

I think that an attempt by the FDA to further specialize the DNDN ruling by attaching unconventional requirements to their decision simply tips their hand and says that they are unsure of the absolute efficacy of this treatment. If they are deliberating making the approval conditional on the results of 02B, then they need to suck it up and hand out the approvable decision.

And if I understand you correctly, then I do agree with you that they need not resort to keeping provenge off the market (or out of CU imo) to make sure that they get a reliable answer from 02B. But if the FDA is so concerned about 02B, I think it is reasonable to wonder why?

===

Are we sure it will take until 2010 for data? If there are 400 patients in the trial (~100 as of a year ago) and it is event driven with a trigger in the 300s (if i'm not mistaken), then 2 years from today there should be at least 200 events and likely many more. The talk of 2010 makes me think that DNDN is going to try and change 02B into a single 36 month survival analysis as primary and try to dump the event driven analysis. JMO.

Nice to see you posting here.