Replies to post #559445 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

The P3 trial had great results. Complete nonsense. Thanks, Ex.

Bluebook is not helpful.

[SkyLimit2022]

Thanks for the reply.

No problem—it sounds like you would prefer a completely different trial from the P3. Take a look at the combo trial! It has a great placebo design that I bet you will love:

The UCLA combo study deserves more publicity and many people are unaware of its interim survival data.

For those who might not have heard:

Aside from the well-publicized P3, there is another clinical study for murcidencel + pembrolizumab specifically for rGBM that has reached its midpoint with interim survival data. This study does not involve any chemo or radiation. OS has not been reached yet because patients are alive. This trial is using an internal placebo control group who are all receiving murcidencel—only Keytruda in combo is being investigated.

https://clinicaltrials.gov/ct2/show/NCT04201873









https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter

https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/

[flipper44]

Ex, those endpoints were changed years ago. Are you getting senile? There are new treatments.

[biosectinvestor]

Ahh, but that is not what happened. Endpoints were changed, which happens, we have discussed it before for big pharma trials in the past, even where one BP had to throw out their previously granted Special Protocol Assessment to change the endpoints during a trial.

PFS is only a proxy for survival. As it was as a measure at the time of the trial, it was clearly NOT a valid surrogate measure for Ongoing Survival. The trial did not fail in any way on the basis of survival and in this case, as to PFS, the measure itself failed, not the trial. It failed to be a valid proxy for survival.