Revance Therapeutics Inc (RVNC)

[mouton29]

The details of the FDA inspection process are new to me, but you stated,

Pre Approval Inspection results are still not posted on the FDA website

and provided a link.

However, it it doesn't appear that pre approval inspection results are actually posted, from the FDA website at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-classification-database:

Not all inspections are included in the database. Inspections conducted by States, pre-approval inspections, mammography facility inspections, inspections waiting for a final enforcement action, and inspections of nonclinical labs are not included.

If I understand the timelines you have outlined, after the inspection (end of June), FDA has 45 days for PAI, which brings us to August 15, but there is then another 30 days to issue the EIR, then 15 working days for the company to respond, and then the FDA issues NAI, VAI or OAI?