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Sikmarson

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Sikmarson

Re: Whosetosay post# 75019

Monday, 08/01/2016 11:21:47 AM

Monday, August 01, 2016 11:21:47 AM

Post# of 80490
Think youre right, FDA will approve brigatinib not as fast as Ponatinib.
Ponatinib was one of the fastest approvals ever.See link
CDER Drug and Biologic Accelerated and Restricted Distribution Approvals
The week after next we´ll complete the rolling submission of NDA (60 days after NDA), and then up to 6 month for Briga approval, -if they get granted the priority review

This was the timeline from Ponatinib approval:
07/30/2012 ARIAD Announces Submission of New Drug Application..
09/27/2012 ARIAD Completes Rolling Submission of New Drug Application..
10/24/2012 ARIAD Announces U.S. FDA Acceptance of NDA..
12/14/2012 ARIAD Announces Accelerated Approval by FDA..

glta,
Sik





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