NorthWest Biotherapeutics Inc (NWBO)

[Love Boat Captain]

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

“New active substances and biosimilar products
The assessment process includes consultation with the CHM on fixed dates each month. The submission slots will be linked to the dates of CHM meetings. The MHRA may additionally wish to seek advice or input from therapy area experts (specialty expert groups) during the assessment process.

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.

For new active substances and biosimilar products the orphan status will be determined at the time of MA grant. If orphan status is not agreed and the company wishes to appeal this decision, the grant of a marketing authorisation will only be possible when the appeal process is completed.”