Yep, I remember this all now. Thanks, Senti.
I’ll say it now if I didn’t say it exactly this way then. Hogwash.
I indicated then I am nearly certain that I believe FDA would consider the imbalance still randomized since everyone else involved did not know it occurred, assumed randomization happened and all remained blinded. In 2019, Les still remained blinded. Technically, until sites were locked down and sometime thereafter, they could not really see where imbalance even sat and I am sure it is spread over many sites, where the last 32 enrolled.
I picture this, Les, Marnix LP and a few others siting around a table discussing the possibilities that explain a 32 imbalance of patients who substantially weakened my study by taking 2:1 randomization up to 2.34:1. A study that I am also led to believe has regulators somewhere halting me for some, the gods of trial design only know, reason…oops I mean halted new screening as otherwise everyone else just carried on forward as if nothing in the world just happened. And I am suppose to believe this at a time when everyone still says FDA is making them use the original endpoints…LOOK OUT FOR THE POTTED PLANT.
Yes, I am certain that something like this came out of somebody’s mouth in that meeting…“I don’t know maybe some flaw some where happened during randomization and somehow the system that corrects imbalances by every damn factor known to man even regionally went wrong this one time by such a huge number that no clinical scientist on earth out there is gonna believe us, but yea maybe that did happen…pause…if that’s the case then what the hell do we do?” That followed one of them saying…
“We can all see they stopped putting patients on placebo, so how do we answer them to get them to move past it?”
That same person afterwards said probably said something like, “Ok, but I can’t sell that so which of you is saying that, and it isn’t you Marnix? We need plausible deniability.”
“Ok, put on a nice Hawaiian shirt at least please, Les. We have a long time coming still and it would be nice to maintain some valuation in case we get desperate again.”
