Replies to post #389239 on NorthWest Biotherapeutics Inc (NWBO)

[VikingInvest]

Completely understand your point, but how would FDA possibly be in a position not to approve DCVax if extremely successful for one group and marginally successful for the other? I am not worried about FDA, if it is successful in ANY group.

[biosectinvestor]

Why would it not? I don’t get your point. They went through the trouble of going back and getting this data. They did so because they noted that their long-tail patients had certain biomarkers. How is it possible that you would consider biomarkers irrelevant? Could you please explain?

I mean Keytruda has a general approval for any tumor based primarily on certain biomarkers being present. Why would you suggest this is irrelevant?

[sentiment_stocks]

I don’t personally think the reclassification that’s been discussed on this board will impact the DCVax-L RA approval as they will be going for an approval for all newly diagnosed GBM patients, and not some sort of subset of patients. There is no subset defined in the new endpoints… but of course, there’s an entirely new group of patients that have been added… recurrent GBM… which, if stat sig, should increase the initial market potential.

As I see it, Northwest having determined the IDH status can help to eliminate any arguments that the longer living patients were comprised of the typically longer living IDH mutated patients, as it would seem, given that that type of IDH status is usually found in the GBM patients who started with a lesser grade glioma, there would be very few of these types in the trial.