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Steady_T

10/16/20 12:47 PM

#276548 RE: imho #276542

The headline is making two points.

Till this trial there hasn't been a trial with a control group i.e. a placebo group. That has been a point of considerable criticism and called into question the strength of the results in the previous data.

Because of the perceived weakness in the previous trials the MOA, mechanism of action, has not been considered to be demonstrated conclusively.
Since the MOA is a new conceptual approach many want to see a controlled trial demonstrate results before they accept the new concept (MOA).

So the headline is pointing out that these trial result prove the concept, which is an important step forward for gaining acceptance of 2-73.

frrol

10/16/20 1:09 PM

#276552 RE: imho #276542

Proof of Concept is used to describe a trial that is (relatively) small and a first for efficacy in the indication. Our PDD Phase 2 was a notably robust "PoC" in size and controls, good things, and he was right to point the latter out.