Replies to post #706078 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

LL did not say at 42 minutes that she expects the DCVAXL NOT to be approved you liar

[Margin Buu]

No where does Linda Liau imply in that video - or any other video - that she expects DCVAX-L not to be approved. I listened to it and you get a big fat troll face emoji for your efforts to spread FUD 👺

[iclight]

Transcript for those who find Youtube too difficult. This does not sound like someone expecting approval based on any submission. She is hoping for "regulatory interest" in ECAs, not approval IF they can get the patient level data from the other trials:

Patients treated with DC VX in the study were compared with the control arms of contemporaneous matched external controls who receive standard of care alone. To mitigate some of the limitations using external controls we did use a novel methodology uh to neurooncology called a make analysis is which stands for matching adjusted indirect comparison analysis which matched patient characteristics between the trials as best we could at the population level.

However we were unable to obtain individual patient level data from the previously published comparative trials so we're not able to do individual patient matching which we are all aware is a current limitation with the use of external controls so I'm actually hoping that our publication uh and the discussions around it will spur the sponsors of these clinical trials to publicly release their individual patient data so that we as a field can further innovate and get regulatory interest in the use of external control arms in neurology and oncology trials

[FeMike]

Start at minuet 42.

Dude...her literal quote is:

Given the very favorable toxicity profile for DCVax-L and it's efficacy, I do hope that it can be FDA approved someday

So when she says "I hope that it can be FDA approved" your takeaway is that she expects DCVax not to be approved? Come on Ex. Be better than the Gap.

[Doc logic]

exwannabe,

Linda is saying that no one wants to release their patient level data and the FDA guidance says that is the ideal way to move forward. There was no way for NWBO to get patient level data to compare with their own. Pretty simple really. The adjudication of this L Phase 3 can only be done with next best data and that includes the fact that historical comps have not changed much over many years in this disease and the use of generally matched comparators by an independent group not associated with NWBO was tested various ways for bias with non found. You can attack the method all you want but the method itself was externally checked by independents and passed muster; ). The bear arguments… not so much; ). Best wishes.