Replies to post #730079 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

By "placebo group" you mean the patients receiving chemorad SOC.  No, In PFS L failed to separate from SOC and maybe even did worse.  That's why the FDA stopped enrollment. The part of the control group that disappeared the data are the ones who didn't crossover. 

[JTORENCE]

meirluc " it would soon be the FDA with egg on its face."
Like the FDA gives a damn about NWBO and having egg on it's face.

[Hopeforthefuture3]

Meirluc does not seem fair but I have heard 2 versions on the crossover. First was the fda required it and second was crossover was needed to get people to join the trial as no one wants to be the control.
Imo for such a deadly disease all trials should have to put all known data into a database for future comparisons. Crazy to require more control patients when there already should exist a wealth of data on soc.
Unfortunately this imo severely limits the near term potential value of nwbo. Have to hope all goes OK in the UK and then Europe next. USA may just have to wait for another trial or for somehow matched patient level data to become available - certainly has to exist from other trials just needs to be shared

[dennisdave]

So why would the FDA be so inflexible in asking for the comparison of patient
level matched controls when that RA should have known that in the case that
their post progression DCVax-L treatment mandate could nix the placebo
group, the trial results, no matter how positive, could not be used for an approvable
BLA because there were no available ECAs that could provide such adequate patient
level matched controls? This would only show the FDA's idiotic inflexibility but I expect
that other RAs (e.g. EU) would be more flexible and should be considered by NWBO.

That's a very good question, but how do we know the FDA asked the control group of patients to cross to the treatment arm for reasons of compassion?
In any case, the FDA is being cold-hearted unreasonable inflexible and irrational. The FDA is asking for patients to die so they can be compared to treatment.

[exwannabe]

Was it not the FDA that mandated that placebo patients who
progressed have the option of receiving DCVax-L after progression?

Not per the trial SAP published in JAMA. Other sources have been inconsistent on this. And LP clearly said it was not an FDA decision, it was needed to enhance recruitment.

Regardless, that decision was for a P2 not designed to establish an OS efficacy benefit. The primary outcome was PFS and wold not be effected by crossover. It was NWBO that elected to repurpose an old quasi-dormant P2 into the P3. That is also why they used an outdated system for determining progression that was already known to fail in immno-onocology in GBM prior to the trial re-launch.