banter and General Discussion, page-1212

Check out the PDUFA Calendar:
https://www.biopharmcatalyst.com/calendars/pdufa-calendar

Stocks to keep an eye on in the lead up to Sept 30 for MSB:
- Mallinckrodt Pharmaceuticals (MNK) Prescription Drug User Fee Act (PDUFA) target action date is September 12. If approved, terlipressin would be the first FDA-approved treatment in the United States for adult patients with HRS-1, a life-threatening condition. AdCom 8-7 in favor.
- Aquestive Therapeutics (AQST) Libervant™ (diazepam) Buccal Film for the management of seizure clusters. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 27, 2020. If approved by the FDA, Libervant will be the first oral diazepam-based therapy approved for management of seizure clusters in the population of 1.2 million refractory epilepsy patients. Libervant was designated by the FDA as an orphan drug in November 2016.