Replies to post #611954 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

I think Les said in his radio show they are working on applicationS. Also I believe they will be submitting via project Orbis which would require more pages.

We will know between now and 3 weeks (is what i heard)

https://www.gov.uk/guidance/guidance-on-project-orbis

The programme provides a framework for concurrent submission and review of oncology products among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies.

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)
Project Orbis Partners (POPs) may propose products for inclusion in the scheme. Each country remains fully independent on their final regulatory decision.