Replies to post #492900 on NorthWest Biotherapeutics Inc (NWBO)

[antihama]

...I’ve argued in the past that TLD will set everything in motion. Now that it has, we’ll hear about FDA Breakthrough Therapy Designation (BTD) being granted to DCVax-L for GBM in about 2 months and a BLA submitted a short time after that. I base this on Amgen’s Sotorasib timeline that I reviewed in post 435926.
Quote:
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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
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I would expect no less from NWBO in pushing DCVax-L through the approval process. Yes, they are a much smaller company w less resources but they’ve been sitting on TLD for probably over a year and may have started communication w the FDA much sooner than when we found out about TLD. And yes, we understand that communication w the MHRA has been ongoing and you’re probably right that we’ll get approval on the other side of the pond first but it won’t be by much. Exciting times ahead! - post 473353 (after the NYAS TLDish presentation)

Granted pqr this is a sample of one but you would think NWBO's DCVax-L should be in that 2ish month window. Some would argue you should double expected timelines when it comes to NWBO but I hope not.