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Monday, March 24, 2014 5:22:02 PM
It makes logical sense to deduce that the steering committee was presented with the dilemma, they in turn approached the FDA seeking "clarification" (from FDA guidelines), the FDA unblinded the PEI according to the obligations of their arrangement, the PEI approved the vacc., enrollment is no longer needed there (halt is imminent), and we are simply waiting on an outcome that would prolong the lives of many more patients than halting now and risking the FDA finding something in the data (type I error) that would cause them to recommend another ph III trial. Whether or not it specifically involves the pseudo-progression group is just an educated guess, but what I outlined above is not. It's the most likely reason for such a lengthy delay (imo). All of the pieces fit this way (especially the 'timely' German approval).
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