A reasonable opinion, not one I hold but certainly reasonable. Dec and Jan are not complete write offs in US it’s the middle of winter there and generally pretty active aside from few days between Christmas and New Years. FDA has published guidance on what an approved Acne product requires so would be pretty straight forward, plug in your data from Phase 2 and describe how you will execute Phase 3.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acne-vulgaris-establishing-effectiveness-drugs-intended-treatment
I feel they need to do better in their execution and communication. Shouldn’t take 6 months to make a meeting request when you knew it was next step after reporting the Phase 2 data.
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