NorthWest Biotherapeutics Inc (NWBO)

[antihama]

The CHM meeting for the submitted application will almost certainly be on January 25-26, 2024, with a much slighter chance it might be on Dec 21-22, IMO. Here's my reasoning. The NWBO PR notes

The Company anticipates submitting the MAA in approximately the next 30-45 days

and the PR was dated Aug 29th. Thirty calendar days from Aug 29th is Sept 29th which is 4 days past the submission deadline of Sept 25th bumping it to the next submission deadline of Oct 30th w corresponding January CHM meeting. And I'm 99.9% certain we get a submission of MAA PR when that happens.

I was originally stumped by the 30-45 day guidance but in rereading the Submission dates for 150-days assessment procedure for national marketing authorisation applications containing new active substances it states

For applications containing new active substances, submissions should be received by the following dates in order to align with the meeting dates of the Commission on Human Medicines (CHM).

I was originally thinking it had to be submitted 'on' a certain date like Sept 25th or Oct 30th but it just needs to be submitted 'by' that date.

Can it be submitted for the Sept 25th deadline? Sure. NWBOs PR does state "approximately 30-45 days" so if they submitted it in 26 days they could make the Sept 25th deadline w corresponding Dec 21-22 CHM meeting but looking at it the other way they can submit the MAA in 60 days and make the Oct 30th cutoff.

Again, we'll know when that happens because they will PR the MAA submittal date.