Alex 2 and S extended for 96 weeks | BCRX Message Board Posts

BioCryst Pharmaceuticals Inc.

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Msg  9590 of 9845  at  3/15/2019 1:33:32 PM  by

biotechie60


 In response to msg 9589 by  lysander_us
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Re: Alex 2 and S extended for 96 weeks

As they intend to file an NDA end of 2019, my guess for the extension would be this:

Surveillance: Post Drug-Approval Activities

A vital part of CDER's mission is to monitor the safety and effectiveness of drugs that are currently available to the American people. To meet this goal, FDA has in place postmarketing programs that monitor marketed human medical products for unexpected adverse events. These programs alert the Agency to potential threats to the public health. Agency experts then identify the need for preventive actions, such as changes in product labeling information and, rarely, re-evaluation of an approval decision


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