Replies to post #621135 on NorthWest Biotherapeutics Inc (NWBO)

[extrooper]

“1. DCVax was the first drug to be designated by UK Authorities as a " Promising Innovative Medicine”

As such, it would make sense they would have been hyper aware of all developments and patient results during the entire clinical.

[XMaster2023]

“ The PIM designation for DCVax-L covers all malignant gliomas” Thanks for your DD. Excellent news for these patients.

[biosectinvestor]

I expect and hope they will apply for rGBM and I would expect and hope that it would be approvable as well. They will no doubt discuss this with their regulators, but when you see the combination therapy trial in the US treating DCVax-L as the SOC for recurrent Glioblastoma, it’s encouraging. The results for the Phase 3 were incredibly positive for rGBM. With no SOC for rGBM it would be extremely promising as a treatment option as well for patients.

But of course speculation is speculation. I do not claim to know anything more than anyone else.

I note the German Hospital Exemption, which required immense due diligence by the German regulator ALSO approved a very broad coverage for DCVax-L as well.

https://nwbio.com/dcvax-l-hospital-exemption-program-now-under-way-in-germany/

NW Bio’s DCVax-L is the first immune therapy to be granted a Hospital Exemption approval under the German Drug Law. The scope of this Hospital Exemption includes all glioma brain cancers, both GBM (the most severe grade) and lower grade (less malignant) gliomas, and includes both newly diagnosed (i.e., early stage) as well as recurrent (i.e., late stage) patients. The patients must receive treatment in Germany, but may be either from Germany or from abroad.

Of course the large barrier to monetizing at the time was the requirement that DCVax-L had to be manufactured in Germany.