Intellipharmaceutics International Inc. (IPCI)

[InTheTrenches]

Schedule for Rexista will go something like this:

- August 1, 2016: NDA filed by company (just a guess on the date)

- October 1, 2016: FDA Accepts NDA or issues Refuse-To-File (RTF) letter within 60 days of NDA filing.

- April 1, 2017: If NDA accepted, PDUFA (decision) date is set for 6 months later if Rexista is priority review--I think Rexista is priority review? (10 months later if Rexista is standard review)

- ~March 1, 2017: If FDA needs guidance on the NDA, they will set a date for an Advisory Committee (AdCom) 2-4 weeks before the PDUFA date, and publicly release Briefing Docs (BDs) ~3-5 days before the AdCom.

NDA = New Drug Application
PDUFA = Prescription Drug User Fee Act