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BioCryst Pharmaceuticals Inc.

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Msg  10704 of 10856  at  12/6/2019 2:13:12 PM  by


 In response to msg 10681 by  map.here
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Re: NDA Comment

"Dr. Sheridan said a request for quick review would be made but he doubts they will receive it due to other medications available."
wait a second...https://www.pharmaceutical-business-review.com/news/biocrysts-hae-drug-bcx7353-gets-fda-fast-track-designation.

The fast track designation gives BioCryst Pharmaceuticals the scope for frequent interactions with the FDA during development of the drug.

It also gives the opportunity for priority review for BCX7353 if backed by clinical data during its new drug application (NDA) submission.

BioCryst Pharmaceuticals president & CEO Jon Stonehouse said: “Fast Track Designation from the FDA serves as another indicator of the importance of BCX7353 to meet an unmet medical need for HAE patients in the U.S."

given on 8/7/18... 

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Msg # Subject Author Recs Date Posted
10705 Re: NDA Comment roddog 0 12/6/2019 2:47:45 PM

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