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AshvsEvilDead

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AshvsEvilDead

Re: boston745 post# 18419

Monday, 08/27/2018 12:28:47 PM

Monday, August 27, 2018 12:28:47 PM

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Not to mention Autograft is optional, and In addition I believe was mentioned as a predicate which was the reason it was rejected to begin with. So they have a clear path to submit. 24month data, plus Europe as well. Initially FDA clearly stated 12mo wasn't good enough, so they required 24month data - this wasn't the issue - it was the predicate If I remember correctly.
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