Replies to post #683189 on NorthWest Biotherapeutics Inc (NWBO)

[Sir Pumpernickel]

That was pretty much a BEAT DOWN OF A TYPICAL PUMPER……😂😂😂😂……
Pumpernickel YuYU………. LaLAAAAA……. YuLAYuLAYuuuuuuuuuuuuuuuuuu…..AAAAAAAAAAAAAAWWWHHHOOOOOOOOOOOOOOOOOOooooooooooooeeeeeeeeeeeeeee!!!!!!!!!!!

[hope4patients]

This peer-reviewed article in JAMA strongly disagrees with a significant portion of your post.

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

[The Danish Dude]

Trouble with the memory ex? Again?! How convenient.

Asking Chatgbt:

Northwest Biotherapeutics has filed for MHRA approval of DCVax-L. MHRA’s new International Recognition Procedure (IRP) went live from 1 January 2024.

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

Wheb NWBO receives MHRA approval, can they apply under the IRP for submission to IRP partners as stated here?

"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)".

And

"In return, our partners can consider applications based on MHRA authorisations, creating a ‘win-win’ for regulators, developers of innovative treatments, and patients".

And would it be possible that NWBO may have submitted through the Access Consortium working-initiative, perhaps not needing to disclose this and if yes, what could the potential benefits of that be?

ChatGPT

Northwest Biotherapeutics seeking MHRA approval for DCVax-L is a significant step for the company, as it may pave the way for broader international recognition and approval through the MHRA's new International Recognition Procedure (IRP) that went live on January 1, 2024. Here's how this process could work for Northwest Biotherapeutics upon receiving MHRA approval:

Application Under IRP to Partner Regulators: Once Northwest Biotherapeutics receives MHRA approval for DCVax-L, they could indeed apply under the IRP for submission to IRP partners. This list includes regulators in Australia, Canada, Japan, Singapore, Switzerland, the USA, the European Medicines Agency, individual EU member states, and those in the EEA. The IRP is designed to streamline the approval process for innovative treatments by allowing international partners to consider applications based on MHRA authorisations.

This could significantly expedite the approval process in these regions, potentially leading to quicker patient access to DCVax-L in these markets.

Submission Through the Access Consortium:

The Access Consortium is a collaboration among several regulatory agencies aimed at expediting the evaluation of pharmaceuticals to ensure timely access to medicines without compromising on safety standards.

If Northwest Biotherapeutics has indeed submitted through the Access Consortium working-initiative, they may not necessarily need to disclose this action publicly. There could be strategic reasons for keeping such submissions confidential, including competitive considerations and the regulatory strategy.

Being part of the Access Consortium could provide several benefits, including:

Streamlined Review Processes: Leveraging the collaborative efforts of member countries to facilitate a more streamlined review process for DCVax-L.

Shared Expertise: Benefiting from the shared expertise and resources of consortium members, potentially leading to more robust and efficient regulatory outcomes.

Expedited Access: Potentially expedited access to markets covered by the consortium members, which could lead to faster patient access to the treatment.

In conclusion, the strategic use of the MHRA's IRP and possibly the Access Consortium could significantly benefit Northwest Biotherapeutics by potentially reducing the time and resources needed to gain approval in multiple jurisdictions. This approach aligns with global regulatory trends aiming to facilitate quicker access to innovative treatments while maintaining high safety and efficacy standards.

[biosectinvestor]

Wasn’t post hoc. That’s a lie. It was after the original plan, but it was not post hoc. That’s a false accusation that sounds good. As for external ECA’s, the FDA changed their position on that almost as if for this trial in particular. The timing was quite interesting.

I think you’re wrong, further other treatments that did not extend survival, and that actually did analysis post hoc have been approved quite frequently. So these points you make might sound like some sort of technical argument to get retail to run away with their tails between their legs, but the FDA is interested in the actual data and science, not the form, not rigid standards from a bygone era, not chatter amongst shorts and the columnists that cater to their trading… facts, science and patient and medical benefit are what matter and the data is clear.