Replies to post #690483 on NorthWest Biotherapeutics Inc (NWBO)

[Ockain]

“The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission. “

I think this is a good indication of even if an RFI was issued it was for minor concerns at worst

[Steady_T]

I read this from the GOV.UK website linked below.
As I read that it means the assessment i.e. the 150 clock starts after validation. ChatGPT sees it differently.

If that is case then the clock started Jan 24th.
80 days for the Phase 1 assessment would be about April 16th. If there was a RFI it would have occurred about then. With no RFI then the clock times out about June 23rd.

If the clock started on the validation confirmation add 43 days to June 23rd and make it about August 5th.

https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines

Validation
The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.

The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.

Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. Assessment in phase-I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings. Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.

[LessIsMore]

If the application is valid then the assessment period will begin. This starts from the date of receipt of the valid application. If the application is not valid, then the person making the application will be told of the deficiencies

https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/common-issues-validation

[exwannabe]

I agree. Language of "upon submission of a valid application" is in all formal documents that have been found. That language is clear. For a submission that is found to be valid, it s the submission date.

Assuming that NWBO's statement can be taken on face value, the clock starred in Dec It would still gate back to Dec 28trh to align with the submission slots.

Can StonkMonster reset his clock?

Also agree with you that this does not read on an an RFI, though I find the concept of none being requested a bit hard to take seriously.