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Re: exwannabe post# 136205

Sunday, 09/24/2017 3:11:32 PM

Sunday, September 24, 2017 3:11:32 PM

Post# of 828574
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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