Replies to post #741442 on NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Approved 10 months from the first CHM meeting!
The approval is based on findings from the phase 2 DeLLphi-301 study (NCT05060016).
DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study, did not include a comparative placebo arm.
This product (Tarlatamab) was submitted and approved via a national procedure as part of Project ORBIS.

On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy

[jtaylor042]

It is encouraging if we're 6+ mos in.

[exwannabe]

So it took nearly a year from the first CHM meeting to approve a drug that is already approved elsewhere worldwide? That's not super encouraging.

What is worse is that it was approved via ORBIS, so the MHRA was piggybacking on the FDA staff review used to approve back in May for the US.