@Bio
To me this is a block buster.
I wonder if there are any other regions that require this type of info?
I would guess Europe makes up at least 20 to 30% of the events, being drinking and smoking is very prevalent there.
With that said, CVM can see a significant set of data and only doesn't know which clinical arm the events were in.
BUT they do know the case number of each event.
Well how do they make each treatment on demand as requested by the doctors for one arm and my guess is the request MAY very well have the case number attached. Otherwise, how does anyone know which patient to give it to.
I mean they don't give shots of manufactured sugar water to the SOC arm do they?.
If this theory holds true, then CVM can deduct who died in which arm using their professional tacticians to determine the clinicals success in that region. Again, if true, I don't see Europe having any significant difference from the other regions of the world.
So CVM may very well already have strong data of the clinicals results.
Thus going around with the 'We Believe' comments.
But as usual, I could be wrong.
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Clinical Trials run in Europe are under the regulatory authority of the European Medicines Agency. They require an annual report by the Sponsor of every clinical trial investigating the effects of an investigative drug application. Now Cel Sci is the Sponsor of this trial. One of the data points the EMA requires to be submitted annually is:
***List of subjects who died during the reporting period
***The list of subjects who died during participation in the clinical trials should include the following information at a minimum:
case number,
assigned treatment (could still be blinded),
and cause of death of each subject.
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