Replies to post #437291 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

When did you first connect that they couldn’t have performed an efficacy interim analysis back in 2015 because they had no SAP (at that time) to guide them?

[biosectinvestor]

Glad to hear this confirmed from another source. Thanks Senti.

[sentiment_stocks]

Now I realize why flipper asked me about 2016/17. I can’t pinpoint exactly when I first heard fro an outside source that an SAP did not exist… I believe it was around 2017 or 18, flipper, but I’m not sure of the year, although I could figure it out if I had to based on my multiple conversations with this person. It was still before, I believe, we started hearing that they were finally in the process of making one.

What I didn’t realize until the other day, was that an SAP was required to perform an IA.

[Doc logic]

sentiment_stocks,

Absolutely correct. In the rules concerning exceptions to adequate and well controlled trials there are only two time points for the SAP to occur and they are at the beginning of the trial or at the end. Because of the adaptive trial design they would have chosen to make sure the SAP was done at the end of this trial which is when they said they were working on it. There have also been recent reported comments attributed to NWBO attesting there has only ever been one SAP.
Excellent observation and it kind of puts a big monkey wrench into the failed trial or futility argument as the endpoints could not have been measured with an SAP even if futility could be argued for based on unadjudicated measures found in the original leaked protocol. Something tells me that this is what the bears were hoping would stick, especially if someone close to the trial said something off the record inline with this. Thank you and best wishes.