Replies to post #661691 on NorthWest Biotherapeutics Inc (NWBO)

[pgsd]

WOW your pathetic attempts at FUD are worsening. This is totally irrelevant to the fact that WHEN we receive MHRA approval we can then apply to use the IRP procedure


"Regardless of the submission date, this does not change the process in the UK as -L is not approved by any of the other RAs"

IRP is not a temporary procedure, NWBO will not be attempting to access the program until MHRA approves DCVax, your B/S comment is exactly that.


"For other countries that follow later we will have to see what they do"

Can you read the guidance and procedures, or are you just ignoring it to suit your agenda (as usual)? "For other countries that follow" yeah right

The guidance lists the specific countries signed up to this program as I have posted and as you are well aware, your B/S again is ignorant of the facts

Honestly, I personally believe your posts were never credible but please get with the program and improve your game, your responses have become a joke. get a grip!

https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure

[pgsd]

Let us take a closer look at Ex's B/S

"ECDRP and MRDCRP submissions received before 1 January 2024 will be processed under the existing practices. For ECDRP applications, the Committee for Medicinal Products for Human Use (CHMP) positive opinion (but not necessarily the European Commission Decision) should be received before 31 December 2023"

Nobody has said anything about NWBO accessing these procedures so B/S and irrelevant, again just trying to spread FUD with nonsense as usual.

https://www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure

https://www.gov.uk/guidance/decentralised-and-mutual-recognition-reliance-procedure-for-marketing-authorisations

"IRP will be open to applicants that have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators (RRs). A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR authorisation for the purposes of IRP"

Again totally irrelevant, after MHRA approval when we will meet the criteria of being approved by one of the partner agencies (MHRA) we will be using the procedure to (IRP) to apply to all the other partnering agencies, as Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said

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

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