The FDA would love nothing more than to stick to its normal processes. They then retain credibility. As expert doctors, such credibility is part of who they are. The alternative would be unbearable for these people. Any trump demands would drive them to self combust in anger!
The sponsor will also not have a tarnished product.
Thus, I trust they will be working on the priority review and approve prior to any ARDS approval.
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- Ann: FDA Accepts BLA for RYONCIL and Agrees to Priority Review
Ann: FDA Accepts BLA for RYONCIL and Agrees to Priority Review, page-132
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