ACAD PDUFA

This is super important to remember, the FDA straight up told them to expect an Advisory Committee Meeting over this, and yet as of Mid May, has not announced it yet.  It is not guaranteed, but because they already announced the Ad Com, they probably are not going to be postponing the decision again.  Most likely, they will announce that AdCom to take place 15-30 days before the PDUFA.

Traders tend to act negatively when an Adcom is announced, assuming that if the FDA was confident in their expectation of their decision, there would be no need for the Advisory Committee to take place.  However, it was clearly stated in the link below that the FDA would indeed ask for an Ad Com.  Short Term Traders who are “Runup” type people are likely to keep a close eye on the announcement of the Advisory Committee request, as that is the day the price could dip significantly, especially if traders weren’t paying attention to that key detail (we often don’t!).

Another key thing to remember about Adcoms, is that they are a RUMOR FUELER.  The suggestion by the Ad Com is not the end all, be all.  The FDA makes its own decision and takes the Ad Coms suggestion into account.  There are numerous examples where the Ad Com suggested the FDA would fail it and the FDA came back with approval.  There are also examples of the opposite.  Volatility will be created by the Ad Com, but the final decision will come from the FDA.

PR for PDUFA Info: https://www.businesswire.com/news/home/20220309005324/en/Acadia-Pharmaceuticals-Announces-August-4-2022-Action-Date-for-Resubmitted-Supplemental-New-Drug-Application-for-NUPLAZID%C2%AE-pimavanserin-for-the-Treatment-of-Alzheimer%E2%80%99s-Disease-Psychosis