Replies to post #611969 on NorthWest Biotherapeutics Inc (NWBO)

[ccie1024]

applicationS

Dennisdave, are you maverick1 ???

:)

[antihama]

Hope so but we'd find out about Project Orbis after we would hear about the status of the MA. Here's the order of things for Amgen's Sotorasib. So, until NWBO puts out the relevant PRs I'm not believing it.

Monday, January 17, 2022 8:11:04 PM

Post#
435926
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Some posters have been saying the BLA has already been submitted to the relevant agencies and that IMO is very incorrect. As been the case in other RTOR submisssions, the canary in the coal mine is we need to hear about TLD/BTD first before we can assume a BLA has been submitted. I went back to Amgen's PR page and pasted the PR titles with other relevant info below since I couldn't highlight your table and it shows TLD then BTD/RTOR (2m after TLD) and NDA submission shortly after that.

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....