This is all Complete Bullshit . . . for example take this one:
No FDA partial hold issue identified,
Please tell us what FDA issue would make any difference whatsoever in the results? Again for example if the FDA at the time had said they believe the trial is futile it would have made no difference since it is now know it wasn't. There is not reason to call this out in the paper other than to try to paint the FDA in a bad light and why when we are working on approval want to do that? All your allegations are bullshit.
Bullish
Men who are occupied in the restoration of health to other men, by the joint exertion of skill and humanity, are above all the great of the earth. They even partake of divinity, since to preserve and renew is almost as noble as to create.