The 9902b DSMB might have access to the final 9902a data, but that doesn’t mean those data will have a direct effect on the DSMB’s decision making.
True. My question was might it be used, along with 9901, and pooled data. I reaaranged your paragraphs a bit below to separate the issue here.
(The DSMB can halt a trial for safety reasons at any time, whether or not the trial has an SPA.)
No argument. well known fact.
A trial that has an SPA—as 9902b does—can be halted by the DSMB for efficacy reasons based on criteria and timetables for interim data looks set forth in the SPA. The DSMB will not halt the trial for efficacy reasons except as explicitly allowed by the SPA. Because the 9902b SPA was established a long time ago, the criteria for interim looks in 9902b presumably do not depend in any way on the data from 9902a.
There's the rub. There has been a lot of discussion here on whether they might change that at the upcoming meeting (re-Gleason score enrollment).And my point was not that 9902b depended on data from 9902a, but the total package to date 9902, 9902a, pooled data.If the interim looks of 9902b look like a dupe then why not let the BLA be approved without 9902b being completed. A possible SPA change outcome from the forthcoming FDA meeting that shouldn't be overlooked.
The ratio of purchased calls to puts the month of that meeting might give an indication of what the market thinks might happen. I'm sure the nuances of every FDA Doc conversation at beltway cocktail parties has probably been recorded three times . :>)
Hence the short answer to your question is No.
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