Replies to post #560704 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

That is not true. Knowing patients continued to be treated despite recurrence is not a breaking of the blind. That is flatly false. The FDA definitely does not see it that way from my research and in fact this would not be considered in any wa a breaking of the blind. Total nonsense and it does not need to come from shipping data.

They do know who has recurred at certain points in time, and how many patients are continuing to get treatment, they do not have to see what is being shipped to whom.

Breaking the blind means seeing who was control arm, who was not, when they got what drug and when. That is not the data they needed to make their conclusion as to how many had crossed over. You know from the structure of the trial that you have x number of control arm patients and y treatment arm. You know your recurrence number, and you know how many patients continued treatment after recurrence. They do not know which of those patients are in which arm to start and which actual patients crossed over to know mathematically what has happened to their control arm. If virtually everyone chose to continue, they know within that group so many will have been the control arm, be getting the drug.

[CaptainObvious]

The point is moot. DCVax will not be denied approval over this issue. The RAs have discretionary leeway.

[sentiment_stocks]

The crossover data was obtained from shipping records. Problem is, those records would be a near perfect unblind of the trial.

True, NWBO was never unblinded. Just the shipping records under control of LP were used to generate unblinded summaries to LL et al.

What you suggest is not what happened… what you are stating occurred is simply your THESIS. However there is a problem with your thesis and that is that almost always it is the CRO which handles the drug or vaccine dispersement, not the manufacturer or the sponsor. So Cognate very likely simply shipped the vaccines to the CRO (Parexel and Synteract) who then distributed the vaccines to their respective treatment centers.

And because both the DCVax-L vaccine and the placebo vaccine were manufactured for all the patients, then Cognate would have shipped both sets (treatment and placebo) to the CRO, who would be responsible for distributing the vials to the treatment centers. So your theory that LP had access to the shipping records via Cognate, and therefore knew which patient began as treatment and which patient began as control does not hold water because (1) Cognate very likely shipped both sets of vials to the CRO, and (2) LP wouldn’t have access to the CROs blinded shipping records.