Replies to post #741439 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

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.

[learningcurve2020]

https://www.reuters.com/business/healthcare-pharmaceuticals/uk-approves-mercks-therapy-rare-lung-condition-2024-12-31/

[H2R]

Tarlatamab under Project Orbis

Hi Lykiri,

Thanks for pointing us to this link:
https://www.gov.uk/government/news/tarlatamab-approved-to-treat-adult-patients-with-small-cell-lung-cancer

The paragraph that caught my eye was the following:

This approval has been granted under Project Orbis, an innovative programme that allows participating regulators to review and approve applications for promising cancer treatments quickly and efficiently.

From Project Orbis, https://www.gov.uk/guidance/guidance-on-project-orbis

Project Orbis is coordinated by the US Food and Drug Administration (FDA). Alongside MHRA, it involves the regulatory authorities of:

* Australia (Therapeutic Goods Administration (TGA))
* Canada (Health Canada)
* Singapore (Health Sciences Authority (HSA))
* Switzerland (Swissmedic)
* Brazil (Agência Nacional de Vigilância Sanitária (ANVISA))
* Israel (Ministry of Health)

Over the years, a number of posts have made reference to Project Orbis. It's the first time I see a concrete use of Project Orbis. And it's for a cancer treatment.

As Senti would say, I'm wondering if that's a rabbit L.P. is going to pull out of the MHRA hat.

Best of luck to Patients, NWBO, and Longs!