Replies to post #706331 on NorthWest Biotherapeutics Inc (NWBO)

[S_mack]

That’s conjecture on your part. My conjecture is the principal investigators wouldn’t have put together the paper and put their names on it if no good faith effort to obtain patient level data had been made.

[dennisdave]

If individual patient-level data was an absolute FDA requirement for ECA then no lethal cancer drug trial could ever be conducted again.
- In that case, the placebo arm must parish to be able to compare that data to the treatment arm. No placebo patient could ever be randomized to treatment which would be very unethical and the FDA knows that, just the shorts are still that dumb to not realize this.
Also in the treatment arm every patient must be 100% identical (twin brothers and sisters?) to the placebo arm patient otherwise the individual patient-level data argument is mute.
- In case no individual patient-level data is available for a certain lethal cancer treatment trial, no ECA comparison can ever be made.

Therefore short's claim that the FDA will always demand individual patient-level data for ECA comparison is idiotic dumb and stupid

[Doc logic]

exwannabe,

Medicenna used their Phase 2 results and patient data to help form their “hybrid” comparator model from a base of compiled data points that were used to match with their data. We know nothing about the specific sources for those matched comparators whereas NWBO’s matched comparators are listed as coming from specific trials. Their comparator was approved AFTER NWBO’s SAP was accepted/approved. So you want NWBO to go back and make changes after they led the way forward in the first place and regulators accepted their situation as pretty unique with the crossover that they insisted upon and the trial that their influence lowered the powering on?; ). Not happening because it’s not needed!; ). Best wishes.