Replies to post #439897 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Do you know this is their plan, or is it your opinion?

Clearly, when they are patient matching, they should not select idh1 mutant patients in the ECA arm against idh1 wildtype in the treatment arm. That’s just foolhardy.

They can get matches from trials and/or hospital registries.

They could also use it for comparing placebo versus treatment arm.

What you are saying only makes sense if the PR department has told you what you are saying is correct.

[hoffmann6383]

Yeah, it seems like the number is small. I understand for DCVax-L they are separated. I was asking if there isn't good control arms that also separate. My understanding is that taking these out will most likely increase the efficacy data, however small.

By having to keep them in it would seem that all the excitement about the redefinition helping NWBO is misplaced. Like I said prior, good for patients, but neutral for NWBO if we can't take advantage of the redefinition by not having a good control arm.

[biosectinvestor]

That actually makes good sense to me as well. So if, as you suggested later in this exchange that that is the case, I am not surprised. It is what I kind of expected, that they could not for the main comparison, break them out though they might in ancillary discussion, if possible. They have collected the data, but it may not be readily available for a relevant group of historical patients in the form the FDA expects at this time.

Thanks Senti.

[hoffmann6383]

hey senti, as always thanks for the response. Always appreciate your perspectives. my thoughts to your response:

they were going to use an internal control arm of 100ish. Why do they need to know the status of all 1400ish external data points for this to be of use? If 500 of the 1400 separated this data why not go with an external control arm of 500 to analyze the data consistent with the redefinition? This would be 400 more than the aforementioned internal control arm. It seems like this would make more logical sense as it would be an analysis consistent with the redefinition and it would also (in all likelihood) make the data look better.

[dmb2]

sentiment stocks, your point is a good one, the fact that IDH mutation was not always utilized to differentiate patient tumors renders the change in GBM definition less useful than it could be, unless they can successfully focus on a data subset where it was used, but they have to be careful since they are breaking new ground here and the complexity of the data is the main reason they have to wait for publication. Any further twisting or cross examining of data has to be done carefully.

The definition change can cause some noise in the data revelation and they do have to be prepared to address it, hopefully positively even qualitatively if not quantitatively. Knowing that IDH mutated patients were included presumably equally in all trials keeps the playing field even, the good news. The bad news is any crevice in their case may be used against their trial results to generate doubt.

Still all good in my opinion, and I believe they will be able to scientifically properly position this positively in their publication.

GLTA