Priority and Breakthrough Drugs -FDA, page-3

This entire post of yours is non-sensical.

You appear to be conflating Accelerated Approval with Priority Review. They are 2 distinctly different processes.

IMO Starpharma’s DEP drugs based on their open-label salvage therapy Phase 2 results do not adequately qualify for Accelerated Approval. Furthermore Starpharma don’t have the necessary funds to conduct a confirmatory trial which must commence at the time of FDA granting marketing approval.

Secondly, you are putting the cart before the horse with your Priority Review speculation. Starpharma or a partner need to conduct a successful Phase 3 trial first, and then lodge a NDA with the FDA. A Priority Review Application may then be lodged with the FDA.