Replies to post #684647 on NorthWest Biotherapeutics Inc (NWBO)

[User-840664]

You have failed on the most important investment rule. IMO
bet the jockey, not the horse

(finance) One should invest based on the management team behind a venture, rather than on the product or service being sold.

[RobotDroid]

and we're just not quite there yet
Never heard this one before. Oh, wait, yes, as I recall, there were 770 other times quoted that were 'not quite there.....So, history does repeat, over and over.
SOS, different day, week, month....year.

[learningcurve2020]

Even if somehow MHRA approves it you'll still need to wait for a NICE verdict.

[Reefrad]

Sorry when do you think we hear a decision from mhra? Optimistically, pessimistically and realistically.

[antihama]

there just isn't going to be news until MHRA decision. We're waiting on that for all the other wheels to start rolling. It may well be a huge train, but none of the cars will start moving until the engine (MHRA approval) goes.

Exactly!, and as GoodGuyBill recently reminded us:

Northwest Biotherapeutics Provides Update on Near Term Plans for Submission of Marketing Authorization Application

"The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard. The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that [color=red]the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators."
https://nwbio.com/northwest-biotherapeutics-provides-update-on-near-term-plans-for-submission-of-marketing-authorization-application

which brings to mind TDD's post

The Danish Dude
Re: exwannabe post# 683189
Thursday, April 04, 2024 1:20:06 PM
Post# of 683243 Go
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.

IRP or not, MHRAs approval will start the fireworks.