NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

"We’re on track for an accelerated approval, we’re thinking sometime later, in the fall. We’ll have something to say about that in the Q we filed probably tomorrow which we can talk about." — Les Goldman, May 2024, BigBiz

The Q provided two validation dates. The first was validation, (January 24), and the second was validation confirmation, (March 7). They suspected they would receive an RFI, but had almost certainly not received a formal RFI at that point. (We don’t know if they ever received one). Regardless, those validation dates either pointed to mid summer or very early fall if there had been an RFI and 60 day clock off response.

Turns out, we received later public info, on August 2, that inspections had already been scheduled for the future, pointing towards around October 3 being end of 210 days, regardless of whether or not there had been a formal RFI.