Perhaps there is a misunderstanding of what a "RISK FACTOR" is?? First, the company gets to bury it down 16 pages into the SEC filing instead of upfront. And there certainly isn't a bigger risk factor that a post hoc manipulation of the trial and confounding of their trial data.
FDA is sure going to see it as a major "RISK FACTOR" as they are not receptive to highly manipulated trials, much of it post hoc. Ten add the confounding of the endpoint data and post hoc data dredging of the rGBM treatment arm. Never seen so much "RISK FACTORS" in a biotech trial in years.
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