NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Has anybody actually bothered to read the PPA?

Outside of rare diseases in pediatric indications it is a nothingburger.

For the general case what is says is:

. Safety established per standard process
. Efficacy can be based on a single P2
. RWD can be used per FDA guidance.

OK, but the FDA already has this guidance. And the FDA already approves on P2s if efficacy is established.

https://www.congress.gov/bill/118th-congress/senate-bill/4426/text