NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

That is not possible.

What you are describing would be SPA that would be approved before the trial even started. Not now.

The best they can get out of the FDA is a non-binding opinion. And it would very likely be filled with "maybe" langauge.

As far as the other RAs, all they have said is that the changed endpoint is safe and ethical. The acceptance of the IND protocol change in no way says they agree it is suitable for approval.

absolute nonsense this. You are making no sense.

First of all the SAP has already been bought in by the FDA. I know you dont want to accept reality that's fine I don't care but the SAP has already been bought in and thus accepted many years ago. Dr Liau has stipulated that the submitted SAP had no feedback from the FDA 3 months after they submitted and thus therefore the DCVAX L trial SAP has been bought in. I know you think NWBO is nuts but they are not. They amended SAP was OFCOURSE accepted before the data was locked and the trial was unblinded.

Thats not my point and of course you and another deliberately are misinterpreting what I have said. I CLEARLY said that the ECA comparison for this trial has not yet been set in stone by the FDA as a RULE. After Pazdur published his take on ECA in March 2022, I believe NWBO submitted the JA for they felt backed enough to do so but as I said in my post I believe that there are now reviewer(s) that need more in-stone writing if ECA comparison is permitted by the FDA and I think that is what the JA being held up for, before it can be published.