dr.kss/gumshoe evaluates bit clinic protocols, page-5

I don't have time to deal with this "report" fully but this PPA/ITA argument put by the good doctor is somewhat disingenuous.

Folks, we are dealing with a phaseII study here. These are, by definition mainly to test for toxicity and human pharmacokinetics. If we get efficacy data as well, so much the better. It's a bonus. Small numbers of subjects are common. No one is suggesting that the efficacy data collected in Biotrons trials is definitive. Few however could argue that it is not indicative.

Phase III is where the real efficacy testing takes place and there is no doubt that the data thus far collected is worthy of going to phase III.

I'll leave it to others to comment on the rest of the good doctor's "report".