So FDA is now accepting applications for the Commissioner's National Priority Voucher (CNPV) pilot program.

One of the program priorities:

Delivering more innovative cures for the American people. The focus for this priority is transformative impact that far outstrips the threshold for breakthrough therapy designation. Examples could include creating a novel immunotherapy that reprograms the body's immune system to fight multiple diseases; or transforming mental health care through a novel treatment for PTSD.

I wonder if we have sufficient data to warrant applying.