Posted On: 05/31/2016 4:32:27 PM
Post# of 72446
More FUD from him about Brilacidin not getting fast track. My response,
Quote:
Both fast track and priority review will be granted when Leo decides to request them.
On page 3,
"FDA determines whether an application qualifies for priority review (versus standard review) for every application, not just when requested by the applicant. Therefore, the Agency will grant priority review to an application for a QIDP, regardless of whether the sponsor requests priority review status. However, while the GAIN Act guarantees that a product receiving a QIDP designation automatically qualifies for fast track designation, 21 U.S.C. 356(a)(1) states that fast track is granted "at the request of the sponsor of a drug." This request can be made with the QIDP designation request, or at any time during drug development, and can be quite simple (e.g., "Company X requests designations of QIDP and fast-track status for...". No additional justification by the sponsor is needed to support the fast track designation of a drug that is granted a QIDP designation. The Agency does not believe this issue will impact the availability of exclusivity."
https://iacp.site-ym.com/resource/resmgr/FDA/..._Healt.pdf
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