exwannebe, I am with you on the 'throwing' names of singled out individuals without any reserves and putting them up as the factual saboteur of the PPHM 2nd ln NSCLC clinical trial. It is not a good approach.
However, your software example isn't really doing it for me. We will all agree with your assessment that implementing a tested software that still may have bugs is no sabotage. If so Microsoft would have sabotaged the hole world!
There is a difference when it comes to changing an existing PPHM related software/database system of a clinical trial in order to make it make errors that were not there in its original design.
The logic is very simply as far as I am concerned:
A) We accept that the e-mail/phone calls reported with Chris are authentic and in that case we must accept 'intended' actions which do not compare to your software deployment example. That certainly doesn't include pointing at a specific person without grounds.
B) We do not accept that the e-mail/phone call reported with Chris are authentic and in that case sabotage has NEVER been confirmed and we are back to square one (for me that means 80% probability that the error was sabotage vs honest human mistake".
I think the keyword here is : INTENDED And we all know that in an FDA licensed CRO environment procedures are verified, certainly patients assignment and randomization. So the initial data must have been good to pass the verification and then changed afterwards. The FDA last month changed its rules and guidelines for IT related procedures for the clinical trials (access and historic logging of changes).
This may have been addressing the above problem. For the FDA this is not new, I think that Carlton's "we are going to the bottom of this" statement at the Annual Meeting, with hindsight, gives away they knew already at that time they where not dealing with simple neglect. The FDA was certainly involved from the beginning and had time to design new guidelines.
Although I do not agree with the name grabbing without substance I will however not allow you to gratuitously generalize:
But you guys have now taken the board delussion to another level
Also note how many of the 'negative' poster do everything to get this sabotage subject of the table, minimize it or try to defer it to statements like: PPHM selected a bad CRO etc.
It is as if it is of MAJOR importance that doubt is not lifted, that light is not shed on this and certainly that sabotage would not be the case because it would confirm the value of Bavi, recognized by whoever ordered that sabotage (if it is sabotage).
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