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Re: Astavakra post# 83702

Monday, 12/22/2014 12:11:01 PM

Monday, December 22, 2014 12:11:01 PM

Post# of 403025
We already qualify for QIDP benefits. This meeting with the FDA was about approving the design of the Phase 3 trial. The request for the PK data sounds more like the FDA is just dotting it's "i's" and crossing it's "t's".

...perhaps FDA is considering granting the QIDP benefits but needed PK to seal the decision. - Astavakra

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