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flipper44

09/24/17 3:11 PM

#136208 RE: exwannabe #136205

This is all hypothetical, but the reason a small company that is cash strapped might file a "stealth" BLA is because they had to preserve the trial integrity for OS even if the primary succeeded early. Otherwise there would be a full crossover, and OS would not be usable for confirmation. Such a small company would be taking a vow of poverty of sorts or at least a vow of vulnerability in a hostile environment during the time between primary endpoint success and trial completion (aka: reached final number of targeted events) and the responsibility to make the decision related to continuing a trial despite success on the primary early interim analysis might need to be delegated to a steering committee, because it also has patient repercussions. Hypothetically.
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Doc logic

09/24/17 11:10 PM

#136243 RE: exwannabe #136205

exwannabe,

Are you finally admitting that a "stealth" BLA might actually be in play? Best wishes.