NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

- There have been 6 medicines that had their first CHM meeting in H1 2024 and have already received approval. The average time from first CHM meeting to approval was roughly 6 months. (Compare this to medicines that had their first CHM meeting in 2023 or earlier, which took from 9 to 11 and as long as 13 months.) ...

The vast majority of the MHRA work is for established medicines and drugs being approved based on a EMA approval (or Orion, or now the IRL that replaces both). These are very different from NMEs using the national pathway.

As far as the disclosure issue, I see very few companies mentioning MHRA much at all. The issue wrt an RFI was that longs were asserting that as it was never disclosed it did not happen. The real issue with NWBO is disclosure is the PR minor stuiff and big issues they have a radio blackout.

. Actual plans for FDA/EMA submissions
. Reason for the FDA hold
. FDA/EMA post P3 meetings
. Commercial contract with Advent for mfg
. NICE evidence submission

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