NorthWest Biotherapeutics Inc (NWBO)

[antihama]

Truthfan, in rereading The Vital Importance of Working in Partnership with Other Regulators – An Interview with MHRA’s CEO Dr. June Raine, I found the article even more interesting. My reason for going back to reread the article was because in initially reading it, I got the general sense that this well spoken person, Dr. June Raine, as CEO of the MHRA, is very much involved in communications w the other Regulatory Agencies. But heck, I didn't realize or let it sink-in initially that this article is posted on the FDA website and that the meeting in London was with a delegation of FDA senior leaders, including FDA Commissioner Dr. Robert M. Califf. One little item that caught my eye is she started her career w interest is in in drug safety and of course, DCVax-l has such a great safety profile. Here's another bit that caught my eye

What your question really goes to is how will international recognition impact on our regulatory role for the future? My hope is that we will certainly retain some of the important innovation pathways where we add value. Let me give you an example in relation to personalized immunotherapies. Because the U.K.’s health ecosystem is joined up, we're able to bring clinicians and health care organization leaders into the regulatory discussions. In this way, we can consider dedicated regulatory pathways for products that have a very short shelf life or products that are tailored to the genomics of a particular cancer or indeed therapies for very rare genetic disorders. These are quite a challenge for regulation, and it's not going to be ‘one size fits all.’ The question is whether we can license platforms as opposed to products. This is a really exciting time in the evolution of regulation, and my ambition is for our voice to be part of that international discussion that is now ongoing.

Senti already posted the following paragraph to highlight "license platforms as opposed to products" but another part of this paragraph that caught my eye made me realize Dr Ashkan's perceived outsized influence w the MHRA is very much real (see marked in red above).

When, I went back to reread the article, it was more so to see if she mentioned the interactions she has w the EMA. There wasn't much discussion of that, she was mostly discussing the FDA, and rightfully so being she just was in a meeting w the FDA and this article is on the FDA website. I'm sure there is a lot of discussion w the EMA but you won't find it here except

The example that's front of mind since January 1 is our new International Recognition Procedure with trusted regulators, including the FDA. We’re working hard to enhance our offer of regulatory pathways to ensure that U.K. patients can benefit from new medical products at the earliest opportunity.

And from a MHRA PR we know there is a connection

This new international recognition procedure will speed up the licensing process by allowing access to the expertise of other trusted regulatory partners, including those in Australia, Canada and Switzerland.

At launch, the MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area).

Applications under IRP can be received via the MHRA website under one of two recognised routes. Time horizons for authorisations are set at 60 to 110 days – considerably shorter than the current 150-day time horizon for applications.

To further streamline the IRP application process, the MHRA launched an ‘Eligibility Checker’ tool on 20 November 2023. Six weeks prior to making a full submission under IRP, applicants should use this tool to determine whether their Marketing Authorisation Application (MAA) is suitable and to identify which route (A or B) to follow.

https://gov.uk/government/news/mhras-new-international-recognition-procedure-irp-goes-live-from-1-january-2024

Anyhows, I think the MHRA is in good hands w Dr. June Raine.