Replies to post #692067 on NorthWest Biotherapeutics Inc (NWBO)

[TTsr]

Great info! TY dennis!!!

[manibiotech]

It is for established medicines . I don’t think anything to with NWBO?

[manibiotech]

And NWBO didn’t apply under IRP to UK either

[newman2021]

super! Thanks for sharing!! you are our Dave Innes now.

[antihama]

DD, I'm not seeing the relevance of IRP regarding NWBOs application. Your link (and the link within the link) refers to

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.

I think we would know if we are accepting RR review. Now, if somewhere it states, the MHRA review will be considered the Reference Regulator that will be used by other Regulators, I would change my mind.

[sentiment_stocks]

Dennis... I'm wondering if this particular pathway applies to the DCVax-L MAA as it is a new medicine, and not an established one. I certainly made a similar mistake here a few days ago in citing a link that only applied to the assessment of clinical trial timelines. You'll note that the opening paragraph on your first link indicates that the guidance for international recognition procedures pertains to initiating clinical trials and "established medicines".

Here we provide the MHRA performance data including timelines for applications for clinical trials and marketing authorisations for established medicines and variations to existing approvals. Our aim is to help applicants with decision-making, based on our performance.

And in the opening paragraph detailing the IRP guidelines, it states,

The product in question is classified as a medicinal product under current legislation and MHRA guidance. How other regulators define a medicinal product in their jurisdiction is of no consequence for IRP applications.

So does the term "current legislation" infer a medicinal product that already has an MAA for another indication?