Replies to post #612284 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Yes, the Sotorasib example has been used as an example of how fast the MHRA/NICE approves new drugs over in the UK.

Amgen PRs:
- TLD – 10.5.20
- BTD – 12.8.20
- FDA's RTOR Pilot Program submission – 12.8.20
- Sotorasib NDA submission to FDA – 12.16.20
- Sotorasib MAA submission to EMA – 12.22.20
- FDA's Project Orbis MAA submission to Australia, Brazil, Canada and the United Kingdom - Jan. 2021
- FDA Grants Sotorasib Priority Review Designation - 2.16.21
- FDA Approves LUMAKRAS™ (Sotorasib) -5.28.21
- EUROPEAN COMMISSION APPROVES LUMYKRAS® - 1.10.22....

And then we have the UK:
Sep 13, 2021 MHRA approves LUMYKRAS based on ORBIS (where UK has access to the FDA review so don't have to do the hard work themselves)
March,3 2022 Nice recommends LUMYKRAS

So despite ORBIS, MHRA was 4 months later than the FDA and actual use was almost a year later.

Yet, LPs paid pumpers keep asserting this is an example of how fast the MHRA/NICE are now.