Amarin Corp Plc (AMRN)

[sts66]

ITCI was informed FDA was holding an AC 6.5 wks in advance - definitely not the 55 days (business or not) the guidelines state - that's ~46 days notice. But date of the AC appears to back up sst's info that Aug. ACs are relatively rare - announcement was on 6/13 calling for an AC on 7/31 - interestingly, it appears that the FDA made it public at the same time they informed ITCI, which confirms a question I had, whether a company could sit on the knowledge that an AC was going to be held or not - seems answer is no, which is what I suspected:

https://www.streetinsider.com/Corporate+News/Intra-Cellular+Therapies+%28ITCI%29+Announces+FDA+Advisory+Committee+Meeting+to+Review+NDA+for+Lumateperone+for+Treatment+of+Schizophrenia+in+Adults/15608389.html

Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has announced a Psychopharmacologic Drugs Advisory Committee meeting to be held on July 31, 2019 to discuss the New Drug Application (NDA) for lumateperone with the proposed indication of treatment of schizophrenia in adults. Lumateperone is a novel investigational drug with an NDA currently under review by FDA as a treatment of schizophrenia in adults.

FDA’s expected Prescription Drug User Fee Act (PDUFA) action date is September 27, 2019.

And boy, if I were ITCI, I'd be hopping mad about this late announcement - they had better been following JT's conservative path of prepping for one just in case or they might be in for a rough ride at the AC.