A Commissioner-Priority Review doesn’t require the NDA to be filed first - it starts with a pre-NDA meeting, and the NDA is filed only after FDA and the sponsor jointly lock the filing structure.They agree on structure and endpoints for filing together. This is the design goal: to prepare a way to grant a quick review to authorize a drug application, collaborated on by sponsor and FDA, to provide aThe NDA for a Commissioner-Priority Review is filed after the FDA and sponsor complete the pre-NDA meeting.
The NDA filing occurs after the Commissioner and CDER agree on:Statistical endpoints Data organization Safety analyses Labeling plans Potential REMS / pharmacovigilance Confirmatory trial structure (if conditional approval granted) This is why the FDA request for a meeting is not a small thing - it is the starting gun.Is it customary for the FDA to request a meeting with a company seeking a drug approval or the other way around?
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