NorthWest Biotherapeutics Inc (NWBO)

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The off clock period isn't required while approval could be done in 80 days or less if MHRA doesnt have additional questions. I believe a lot of this information was already completed with regulators knowing much given the MIA as well as our existing orphan status.

The assessment runs in two phases totalling 150 days with a 60-day clock off period between phases if needed. The first assessment phase will be completed 80 days after the clock starts. Any issues arising during the first phase will be raised with applicants in a "letter requesting further information" (RFI letter). These issues should be addressed within the clock off period. The guidance states that requests to extend the clock off period for up to a further 60 days "may be granted only for exceptions". Phase I assessment will also address eligibility for grant of orphan status.

The second phase of the assessment will start once the applicants' responses are received. The MHRA will operate a 'fixed submission date' system to facilitate consultation with the Commission on Human Medicines (CHM). The guidance recommends that applicants contact the MHRA Assessment Team ahead of their intended date of response submission to align with the CHM's meeting schedule.

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

If Northwest Biotherapeutics and regulators move quickly then these phases can be completed in 80 days or less as that's what happens 97% of the time.

PM2
Area: Medicines licensing, assessment of applications
Target description:

a) The assessment of applications for New Active Substances (NAS) Marketing Authorisations for UK/GB - 97% assessed within 80 days (National including Orbis and Access Consortium)

Target: 97% assessed within 80 days

https://www.gov.uk/government/publications/medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-2021-to-2022/the-medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-202122