There is no way IMO that the regulator you discuss would not require input before releasing the information that there is a 32 patient discord from proper randomization procedures favoring treatment. This information was not public before Mar 2017 and was preceded by FDA lifting the trial hold and company agreeing to end enrollment. This was not coincidental timing of events.
It also confirmed our theory and cannot be otherwise explained rationally by anyone here. Death by placebo must be removed from trial. Now how do you handle those placebos that have not yet progressed? Regulator? Are they still placebos because that’s not the intent of intent-to-treat?
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