Replies to post #730036 on NorthWest Biotherapeutics Inc (NWBO)

[theorysuit]

Then if the fda told them this patient level control data was needed....shouldn't NWBO informed their investors? Is that too much to ask? I feel like nwbo didn't reveal what the fda told them in the post trial meeting on purpose.....

[dennisdave]

Think I do now understand why did not apply with fda. On the presentation on Musellafoundation with Mimivax ceo from July 2023 for next trial they are to randomize 3 to 2 treatment to control. They asked fda (minute 33 or so) if they could use external controls. FDA responded could use external control only if they could find patient level matched controls and they could not find such data. Sad for all the trials that have taken place they do not share the patient level data. Now UK application and not fda makes sense

thanks that is very valuable information and something that we suspected all along here.

[dennisdave]

so NWBO will probably have to run a new FDA confirmation trial with DCVax-l + Poly-ICLC after UK/EMA approval.

[meirluc]

Was it not the FDA that mandated that placebo patients who
progressed have the option of receiving DCVax-L after progression?
64 of the 99 placebos did just that and after receiving their DCVax-L
demonstrated a remarkably long mOS, thus destroying their status as
placebos. It was therefore the FDA mandate itself that eliminated the
placebo group from the trial.

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.

I expect the post approval patients in the UK to do quite well and if submission
of a BLA to the FDA is an impossibility, it would soon be the FDA with egg on its face.