Its not just me thinking CRL...some well respected opinions out there...
BioHunter @TheBio_Hunter 4m $AGRX not sure how FDA can get this across goal line by 11/16. Company needs to provide info and if FDA is leaning toward approval how are they going to get label done post ADCOM. CRL coming imho as we should have already seen “delay PR” last week
Here is a good example of the FDA requesting additional info at the last minute resulting in a 3 month pdufa delay for another drug company I was involved in. In many cases a PDUFA delay is the FDA trying to get info so they can approve the drug...
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