Replies to post #675229 on NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

The guidance for the 150-day route says that a decision will be reached on approvability within 150 days from submission, (not validation) which is actually a Saturday, May 18th, so on or before Friday May 17th.

The MHRA offers a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs), aiming at accelerating the availability of medicines for patients in the UK.

Under this process, the MHRA will evaluate the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation and reach its opinion on approvability within 150 days of submission of a valid application.

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