I totally believe in double-blind studies and know something about their construction. I have relied on this knowledge to reassure myself that the IDMC has not released anything more than a binary outcome (yes/no). I believe this would be the case in Australia.
But the trial is not in Australia and there have been well constructed arguments here that say that more than this has been revealed to the main parties. The most compelling were by aatisket in posts
310 and
311 where the following quote was posted:
"For the avoidance of doubt, Cephalon shall have a right to withdraw from the P3CHF Trial only if (1) the Statistician determines that the surrogate endpoints set forth in paragraph 3 above have not been achieved;" (my emphasis).
How could TEVA and MSB know these endpoints had not been met if the output from the IDMC was merely binary?
I very much hope you are right and that TEVA left for
purely corporate reasons. But I would like to see this in black and white. The absence of this information leads me and others to speculate. It is my belief that this level of disclosure would NOT compromise the trial. If anything, the ongoing speculation on why TEVA left could. I would like to be
certain of the reasons for them leaving, but I am not certain.
If you happen to know of an MSB announcement reassuring the market that
NO detail information on the preliminary review was released to either party, then please point it out to me. I would be very grateful. But, if you don't know of one, would you not want this reassurance also?
I go back the main point of my previous post. I feel that I have not been given enough information to make an appropriate investment decision. Instead, I'm unnecessarily relying on conjecture.
(20min delay)