Schmiggins concern about the "other shoe" to drop | SRPT Message Board Posts

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Msg  14057 of 14098  at  1/27/2020 4:14:05 PM  by

pineappleguava


 In response to msg 14056 by  schmiggins
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Re: Schmiggins concern about the "other shoe" to drop

No, the acceptance of the NDA for review was sometime in December.  I believe the company finished their rolling NDA in October and the FDA is supposed to accept or reject it within 60 days. If accepted then a PDUFA date is set.  There was a comment I read that said the FDA was requesting additional info on how biopsies were looked at.  Some on twitter only noted that the FDA was holding it up.


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Msg # Subject Author Recs Date Posted
14058 Re: Schmiggins concern about the "other shoe" to drop schmiggins 0 1/28/2020 9:34:59 AM






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