Replies to post #596770 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Don't give fuel to the bullshit narrative that the trial design is questionable. The FDA and MHRA approved the design. No point in arguing twisted readings of guidance documents. The issue is settled. The DCVax-L trial design has been approved by regulators. Shareholders fall into the hedge fund social media trap when they engage.

[exwannabe]

The guidance lists recommended endpoints, and OS vs ECAs is not one.

Sure, I said "is not a valid endpoint" and I should have said "is not a recommended endpoint". Whoop dee do.

That OS is the preferred endpoint is of course true. But as the line you say, it must be adequately assessed. And the FDA does not consider ECAs to so so.

As far as :

But NWBO did not compare its data to externally controlled trials. NWBO compared its data to present Standard Of Care SOC.

That is nonsense. The comp was to to SOC arms of other trials and clearly has the concerns the FDA expresses. The other trials will have different populations. This is as opposed to using individual matched patient data which is preferred for ECA.

As far as C), yes OS can be (and often is) a good endpoint. That does not mean it always is.