I know when the hold started. If it were for possible SAE's or safety, it may have taken them until sometime after Jan 2016 to determine (or admit) the new ones that are related to the L trial. Back to where we started. 7 SAE's noted as of Jan, 12 as of Mar.
As you previously said, the SAE's likely occured sometime prior to either date and at some point they felt it was necessary to update the number. Maybe they occured sometime around July or August? We don't know. So stop trying to rule out with certainty the unknown.
To this day they might maintain that these were only "possibly" (at worst) related. And it isn't the first time it's happened in the trial. So I'm sure they would be comfortable saying that they weren't aware of any new adverse issues. Maybe SAE's are just normal occurrences and don't constitute material information. I still think that multiple SAE's in close proximity, depending on severity, could be enough for the DMC to say hold up a minute while we investigate. Maybe a bad production batch or something. Is it really that far of a stretch? To you and Senti probably..
Also, in your post to Eval, you said the enrollment was at 300 in Aug..blah blah blah trying to show it increased. But you are wrong. From the PR on Aug 21st.
"Over 300 patients have been recruited for the trial. The total anticipated enrollment is 348 patients."
So scrap that and start over. We've gone from over to 300 to over 300. Or aka still some unknown number in between but not 348.
