NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

The total assessment process is actually 150 days as the title of the guidance, and the guidance itself says; “the assessment process will run in two phases totaling 150 days.”

It really can’t be more clear that there are two phases of assessment; the first phase is 80 days, and the second phase is (implied) 70 days. And, if required, (because the application is missing information or needs clarification) a RFI is sent requesting the necessary information, while the 150-day clock is turned off.

I believe some people may be reading that as though the “if required” part applies to the second phase, but it doesn’t. It applies the the RFI, rather than the second phase. (so the RFI may not be required, but the second phase is required) Again, it’s not called an 80-day assessment, because the second phase is not optional.

The assessment process will run in two phases totaling 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.

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