NorthWest Biotherapeutics Inc (NWBO)

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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.

MHRA.Gov

By all appearances, we moved on to phase II. However, according to the language above, some companies won’t need to, because they will not receive an RFI, and therefore, according to their language, no Phase II would start or be required.