NorthWest Biotherapeutics Inc (NWBO)

[Red_Right_Hand]

There is no 60-day clock off if there's no RFI. The 60-day clock off is up-to-60 days for applicant to answer the RFI. If no RFI, then no clock-off.

The assessment runs in two phases totalling 150 days with a 60-day clock off period between phases if needed.

https://uk.practicallaw.thomsonreuters.com/w-029-1301?transitionType=Default&contextData=(sc.Default)&firstPage=true

New active substances and biosimilar products
...
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.

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