NDA Comment | BCRX Message Board Posts

BioCryst Pharmaceuticals Inc.

  BCRX website

BCRX   /  Message Board  /  Read Message

 

 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board
Msg  10704 of 10856  at  12/6/2019 2:13:12 PM  by

huskys4u2


 In response to msg 10681 by  map.here
view thread

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... 
 


     e-mail to a friend      printer-friendly     add to library      
| More
Recs: 1     Views: 142
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board

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






About Us  •  Contact Us  •  Follow Us on Twitter  •  Members Directory  •  Help Center  •  Advertise
Not a member yet? What are you waiting for? Create Account
Want to contribute? Support InvestorVillage by donating
© 2003-2019 Investorvillage.com. All rights reserved. User Agreement
   
Financial Market Data provided by
.


Loading...