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TOPIC: BARDA IDE submission

BARDA IDE submission 25 Nov 2016 16:15 #8090

  • franshei
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If Hedrick and CYTX is correct regarding BARDA IDE FDA acceptance before the end of 2016, then the submission/filing of the IDE should have already taken place.

It would take 30 days for FDA to accept or reject the filing. CYTX would probably not making such an announcement, till the 30 day waiting period is up.

Per DOV, CYTX (Kesten and Marino) met with the FDA in August and made an presentation regarding the pending IDE submission and general development plan. Per FDA guidance, the BARDA IDE is put together. This document should be very comprehensive, covering all aspects of the preclinical animal and non animal studies (including safety and efficacy data), CTX2 and reagents and end stem cells drug products (as in a drug master file) , phase i/2 clinical trial protocol, etc., publications, patent protection, etc. The drug master file will continue to expand in the future.

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