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.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
AI
