Ann: Final Sofdra Labelling Discussions with FDA, page-253

I am not sure any of us REALLY actually KNOWS. It will happen when it happens. Everything else is speculation and interpretation. Does it really matter.

Firstly, for me, No - it doesn't matter when approval actually arrives. It'll be here soon enough and I'm happy with that. I agree that the precise date to the minute cannot be demonstrated until it happens, BUT we have some more than indicative guidance. I'm good with that and am pretty confident 20 June (21 June Australia time) will see the FDA have completed their 6 month review of BOT's Class 2 NDA Resubmission for Sofdra. Does it matter to me if the FDA are a few days, even weeks, late - no.

I'll let the FDA explain:

As referenced in the Prescription Drug User Fee Act of 1992 (PDUFA), the Food and Drug Administration (FDA) committed to certain user fee performance goals, including the goal of reviewing and acting on an applicant’s resubmission of an original application in 6 months or less. In the November 1997 letter to Congress regarding the reauthorization of PDUFA, the Secretary of Health and Human Services committed the FDA to recognizing two classes of resubmissions: Class 1and Class 2.

Then from the FDA 2023 Performance Report to Congress:


So in 2022, 97% of the time the FDA successfully reviewed Class 2 NDA Resubmissions within 6 months. It is a goal of the FDA to meet these submission timeframes. Hence I expect (with about 97% certainty) that we will hear about approval on Friday. But, I couldn't give a fat rat's if I'm wrong.