Replies to post #417410 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Hyperopia,

Thanks for the information about the U.K., it reinforces my belief that they should be first to approve. What I'm curious about is, shouldn't it only be a few months difference if all regulators receive the full package from NWBO at the same time.

I know the FDA could cause delays, but if they don't, I believe their PDUFA date would be set 6 months after they receive the BLA, and I believe they're trying to beat those dates.

Barring delays by the regulators, I believe that if the BLA is provided to all four essentially at the same time all four could approve DCVax-L within 6 months of that date. The U.K. will probably be first, but only by a matter of a couple months at most. Of course this is a new technology, and potentially a new paradigm in treatment so delays by the regulators are certainly possible, but I have a feeling the results are so good that they'll want to get the vaccine on the street and not subject their agency to criticism.

Gary

[Lykiri]

I suspect that Northwest Bio will first take advantage of a more favorable route in the UK, and may have applied for the Innovation Passport, which is the entry point for the Innovative Licensing and Access Pathway (ILAP). Nineteen applications were filed in only the first few months of the year, yet to date, only about a half dozen have been publicly announced. (some may have been denied)

hyperopia,

5 months ago I asked MHRA if Northwest Biotherapeutics had applied for ILAP.
Here's their reply:

Dear XXXXX

Thank you for the email. Concerning your question below we do not release this information as it is considered commercial sensitive.

Regards
Graham

Graham Searle

Service Manager

RSBU – Service Management Team

Licensing Division

MHRA

10 South Colonnade, Canary Wharf, London E14 4PU

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

[biosectinvestor]

Interesting hyperopia, but they also had said they would seek the accelerated approval pathways in the US in their financial statements for a long time previous to and just after data lock. So while I expect they will seek the fastest potential route overall, it would not change their likely approval of such status in the US. Interesting but not really responsive to my question.

Also, they’d have to decide if that UK alone route made more sense than doing the Project Orbis route which addresses more jurisdictions at once. RMAT would qualify them for Orbis and their treatment, to me seems likely to be a walk for RMAT status. RMAT is supposed to be very similar to the MHRA status you outline but the FDA is really only putting many of the newer, expedited processes in place now more fully to create basically the same pathways you outline for the UK. But in Orbis, it would facilitate, for the most part, me approval process for multiple jurisdictions, the frustrating part being only that the EMA has not yet signed onto Project Orbis. Canada and the UK are members. One approval, all 3 places.

[exwannabe]

Hyoeropia, there is no reason to believe the UK is going to be faster.

Their main program in the oncology space is joining Project Orion. This allows the MHRA to approve at the same time as the FDA. But even then you still have NICE to wait on.

The other program being mentioned is ILAP. That has produced nothing to date. The first given the ILAP designation was MRK's belzutifan. Was approved by the FDA back in August. Not approved yet in the UK and the schedule for NICE is Aug '22. A full year later than the FDA.

In recent years, I am still not aware of the MRHA approving any oncology drug/biologic that is not a piggyback on the EMA of FDA.

The NICE schedule is still public. Crickets. And that can take a year once they restart it.