Friday, January 22, 2021 9:27:05 AM
First most investors don't think there is a tiny chance of trial failure in primary endpoint
Second if it were a failure measured by primary endpoint, the trial failed by its own definition according to its own SAP. It failed PERIOD
No excuse to withhold the data to the public because of further analyses, or confirmation analyses, or data mining to find other silver lining
Even afterwards the fate of the trial now deemed failure may reverse course (yes there is chance there), it doesn't change the trial failed initially according to its SAP
Thus the company must release the news to the general public even if ultimately the trial would be saved and regained chance of approval.
It's two different things. First you must disclose trial failed in terms of its primary endpoint not meeting predefined metric, and later you also must disclose the trial still has chance of showing both safety and efficacy derived not from its primary endpoint meeting its predefined goal, but from other supporting and persuasive data.
There will be no leeway; otherwise it will become the Old West.
Bottomline: this is a moot point, because the trial is highly likely to meet its primary endpoint in a statistically significant way, hereby the trial will be a success!
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