NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The MAA has to first pass technical validation. This is just the validation that the submission package is proper and complete.

Subsequently comes the regulatory and technical content validation. It is when that is complete that the validation is confirmed.

Tat explains the 2 dates, but leaves one big question.

In the EMA regs (which UK law is still mostly based on) the EMA mys ask for additional information, a correction or a request for clarification. Any of these 3 push the clock.

Clearly NWBO stated they did not need to add information to the MAA, nor did they need to correct t. But they did not deny they were asked for clarification. And if they were, that pushes the clock 2 months.

I guess this can be discussed August when 210 days has otherwise passed us by,.

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance#51-procedure-6901