Replies to post #432120 on NorthWest Biotherapeutics Inc (NWBO)

[newman2021]

MI D, thanks for your DD. I too think one or ORBIS kind of RA approval is happening behind the curtains. There is no question about the expected overwhelming efficacy on the new primary nGBM and secondary rGBM endpoints, but there are shorts then fuding on whether an RA would approve. Instead these shorts should tell the world how to design a GBM trial in the future. Do they allow placebo? Will they let the placebo crossover? Is PFS their endpoint? If so, how would they handle pseudoprogression in the trial?

The latest trial in rGBM is authorized by the very same FDA to have External Controls meaning no placebo involved. How about that? Read the last question in this link.

https://www.outsourcing-pharma.com/Article/2021/07/08/Medicenna-takes-on-deadly-brain-cancer-in-clinical-trial

[highwayman4life]

MI~

I am of the opinion this is what's happening with NWBO but certainly don't have all the details.

-The UK decided to join the project as the Medicines and Healthcare products Regulatory Agency (MHRA) will lose the ability to collaborate with EU countries on drug assessments next year. MHRA’s participation will potentially accelerate access to some cancer drugs in the UK by allowing companies to gain approval while targeting the far larger US market.

-Project Orbis is a programme coordinated by the US Food and Drug Administration
(FDA) to review and approve promising cancer treatments. It 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 across the globe.
The MHRA participate fully in the scheme since 1 January 2021. While the FDA serves
as the primary coordinator for application selection and review, Project Orbis Partners
(POPs) may propose products for inclusion in the scheme.
It involves the regulatory authorities of the following countries:
• Australia (TGA)
• Canada (Health Canada)
• United Kingdom (MHRA)
• Singapore (HSA)
• Switzerland (Swissmedic)
• Brazil (ANVISA)
Each country remains fully independent on their final regulatory decision. Applications
submitted to the MHRA within a Project Orbis procedure are national (GB only)
marketing authorisation applications and variations.

The objective of Project Orbis is to eliminate this delay and allow earlier access to products in countries where regulatory submissions usually lag behind those made in the US. Essentially, one regulatory submission can now yield approvals in multiple different countries.

Look at this Document by FDA for questions on SAP and Orbis Timelines.
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review
8.The protocol and amendments (a list of major changes for each amendment), SAP, and DMC charter and DMC minutes