Replies to post #508602 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

good stuff bio

[jimmy667]

It trials such as the Keytruda/UCLA ATL-Vax (experimental version of NWBO drug) where ATL-Vax is the Placebo arm, the standard of care drug is chosen as the Placebo.
So is not Merck projecting or calculating that DC-Vax is highly likely to be the SOC by the time the Combo trial sequence reaches the Phase 3 Registration trial development stage.

[Dr Bala]

Good stuff, bio. Thanks.

[eagle8]

A very nice overview of many important things that play a role in achieving a cure.
Thank you bio.

GLTU

[HyGro]

"presumably DCVax-L will be approved"?? That won't be until into 2024. Going to take NWBO months to put together the assorted regulatory applications. FDA will take a year for application acceptance and review. That's assuming they a.) accept the application and b.) they don't deliver a CRL.

As NWBO has shown pretty poor regulator interactions (trial hold), decade plus to run a trial, complete redo of the trial protocol, etc. Ain't going to be very soon.

NWBO is the comparator arm, not a placebo. Keytruda is the treatment arm that is being assessed, not DCVax-L. Dr. Liau has moved on and is not touting combination therapy and certainly not claiming DCVax-L is sufficient by itself. Filing a mono-treatment with the dubious trial data -- totally redone protocol/SAP and confounded OS data is going to make the review (if accepted), pretty questionable.