Replies to post #438300 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The Phase iii trial is not open label.

[sentiment_stocks]

Im not asking you anything. Im just saying that I find it remarkable that NWBO did NOT have a SAP in place but did know its endpoints as far back as 2016 is all.

They knew their endpoints for this P3 trial as far back as 2012.

It may seem remarkable to you that they did not have an SAP at the beginning or middle of the trial, but it is not as uncommon as you think. Your endpoints are listed in the protocol.

Thats why I said "Yes I know you cant do an IA without an SAP, but perhaps you should chance that you cant do any without one officially being submitted with the FDA." But now it turns out they did not have any from the start.

Well I'm glad you know that you can't do an IA without an SAP. I didn't, and still don't know that. What I do know is that there was not a previous SAP for this trial, and that the protocol for this trial states that the interim analysis is done WITH using the SAP.

Again unusual since the study is open-label right

The DCVax-L phase 3 trial is quadruple blinded - so not in the least bit open-label.

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
https://clinicaltrials.gov/ct2/show/NCT00045968?cond=DCVax-L&draw=2&rank=3

The cross-over arm is considered open-label, because once you cross over and receive treatment, everyone in that arm is considered a treatment patient - early or late.

What wasn't open label in the cross over arm was who was early and who was late, obviously.