Replies to post #665572 on NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

So if you expect -L to approved by the MHRA under IRP then that means they first have to submit and get approved by some other RA

So you are now saying you misinterpret, what ought to be easily understood, even by a dane like me? Are you so desperate, that you hope for illiteracy to be your saviour? Well looking at your fud colleagues here, you maybe could have a point.

Try to read it again and take a new go at the written word.

Under IRP in the UK when DCVax-L gets marketing application approved, will
Northwest Biotherapeutics then be able to get DCVax-L approved by 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) under IRP and witt new short Time horizons for authorisations, set at 60 to 110 days?

Did you see me write WHEN? That is WHEN DCVAX-L gets approved by MHRA THEN. So no, I do not personally assume us to be getting approved under IRP, but IRP will work for DCVAX-L afterwards.

Yes, it is possible that Northwest Biotherapeutics could get DCVax-L approved by regulators in Australia, Canada, Japan, Singapore, Switzerland, the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area) under the IRP and with new short time horizons for authorizations, set at 60 to 110 days

.

See?

That part said DCVax-L would get approved under IRP with other regulators. I assume after MHRA approval.

This is because the IRP is a regulatory pathway that allows for the expedited review of innovative therapies that have the potential to address unmet medical needs. The IRP is designed to be more efficient and flexible than traditional regulatory pathways, and it can help to accelerate the availability of new therapies to patients.

Nothing about DCVax-L getting approved under IRP pathway

In the case of DCVax-L, the IRP could be used to expedite the review of the marketing application for the drug in the UK. Once the marketing application is approved in the UK, Northwest Biotherapeutics could then use the IRP to seek approval for DCVax-L in other countries that participate in the IRP. This could potentially help to shorten the time it takes for DCVax-L to become available to patients in other countries.

I don't know if IRP in any way can expedite the review time with the MHRA. Flipper seems to believe a SWIFT protocol could have started in the UK by January 1st.

So if you expect -L to approved by the MHRA under IRP then that means they first have to submit and get approved by some other RA.As that has not happened, I guess you assume the present MAA will not be approved and we are waiting for a few years.

DD, when did you turn basher?

Games, must we .... as James Mason would've said.

You know as well as me, that you can only twist and turn my words here to get any kind of bullshit out of this your fud lot can have wet dreams about.