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drbio45

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drbio45

Re: jq1234 post# 164391

Thursday, 07/25/2013 10:33:55 PM

Thursday, July 25, 2013 10:33:55 PM

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No company we know filed accelerated approval without FDA's explicit yes for filing which is why very few NDA/BLA filed under subpart H regulation.

I think it was pretty clear from the conference call that SRPT did not have an explicit yes
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