Replies to post #187777 on Avid Bioservices Inc (CDMO)

[PPHMownsME]

Plus Peregrine said in the lawsuit materials that people have posted from PACER that swapping occured in both arms, so how could the 3mg not be tainted?

[ImaPseudonym]

As was pointed out the 3mg arm was not tainted, but the placebo arm was. So instead of having a clean placebo arm to compare against the 3mg arm, they had to pool the placebo arm and 1mg arm data to use as a comparator. Against that pooled data, the benefit of the 3mg arm did not reach stat sig. So no AA.

[Protector]

No, because the control arm was affected.

The result is by comparison of the 3mg/kg arm with the control arm and therefore the FDA had to take this position. And the 3mg/kg ALONE wasn't stat sig.

So at least they needed confirmation to avoid all kinds of trouble and/or possible complaints later.