NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Well, that was certainly some good digging. Well done.

I would add one point to it. The second CHM meeting (if used, it is optional) is where the CHM provides their recommended thumbs up/down. So it is close to the end.

If there are still issues after that the sponsor, CHM or MHRA can request an oral hearing to argue their point / submit information. That process can take 6 months or more.

Schedule 11 of the UK Health and Medicines Act of 2012 describes this.See paragraphs 5,6 and 7. Schedule 5 of the above discusses the timeframe. There is a mention in Part 5 , para 58 that an oral presentation causes a clock stop. Which can be over half a year per the above timelines.

That is consistent with your observations on the 2 alzheimers approvals. They were both debatable and it looks like they did want to further discuss the approval.