NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Again, not certain that same CHM schedule applies for rolling review. That scheduling is for 150 day review, but everyone thinks we are in rolling review, and that, apparently can be shortened to 60 days (from MAA acceptance) if no issues at end of 60. The whole point of rolling review is to avoid issues upon MAA final submission.

This leaves the question of CHM schedule unanswered for the rolling review thus far.

Add to that the target for both rolling and the 150 day review is to get 97% to approval decision on or before 80 days from MAA acceptance/validation, and one might guess, guess, there’d be a different slightly more expedited CHM review schedule for rolling review, which, would make sense, imo, because all sticky issues should have been dealt with pre-submission acceptance.

Dave is now sending emails that seem to recognize the importance of submission/acceptance in the same breath.