Independent

[flipper44]

At the risk of being impartial: I believe Exwannabe’s position is correct in this particular post as it relates to FDA processes.

exwannabe
Re: Kam8 post# 780415
Saturday, 08/09/2025 1:38:25 AM
The CNPV program is actually 4 months after the CMC section has been submitted as that must be at least 2 months before the complete submission. For active trials this is no issue as the CMC can be prepared in advance of results.

Since NWBO already has the entire submission (subject to whatever they do wrt manufacturing), having a rolling review with CMC in advance is pointless. So they could make a standard submission with priority review for a 6 month PDUFA,. or with the voucher save 2 months. Not a big deal, and certainly not worth waiting for the program.

BTW, 10-Q is Thursday. Non-accelerated.