NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

You are wrong on the 210 days and wrong on the clock starting on the acceptance of the submission

may depend on how long it takes Northwest Bio to respond to the MHRA’s information request.

IF NWBO is confronted (which I highly doubt) with an RFI of 60 days max (and by high exception that 60 days can be extended) then those 60 days include the 150-day assessment period. So its 80-day assessment, 60-day RFI, and 10-day phase 2 for the final decision. What you are saying is 210 days which it previously was. Can you provide me with a reliable source that says phase 2 of the application assessment takes 70 days?

The MHRA will evaluate a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation (MA) application and reach an opinion within 150 days of a valid application being submitted. CHARLOTTE TILLETT partner https://www.stevens-bolton.com/site/insights/articles/uk-marketing-authorisation

Additionally, the assessment clock doesn't start until the application is validated, which could take up to 2 weeks from submittal.

also wrong its after the submission of the application and also again the WITHIN 150 days

The assessment time has been reduced from 210 days to a 150-days assessment procedure for national MA applications containing new active substances. This new accelerated assessment route for MAs does what it says, within 150 days after submission of the application, the MHRA is expected to evaluate and reach an opinion.

https://ndareg.com/news/are-you-planning-to-go-for-approval-in-the-uk-here-is-what-you-need-to-know/ NDA NDA provides unmatched regulatory expertise, partnering with our clients