"He complains there is no real comparison with placebo."
A rather strange thing to say, as there was, indeed, a 26-week randomization period in the trial. The FDA has said a successful outcome can serve as the basis of an sNDA submission. And lest anyone be in doubt, relapse prevention has been a trusted guide to clinical outcomes for at least two decades now.
One wonders what reaction pimavanserin-detractors would have had if the results came back negative. Would they have criticized the study design as unreliable, or seized upon the results as proof that the drug is a dud?
Biotech2k was similarly displeased with the MDD data. My response to him
, drawing on the full weight of the clinical and commercial evidence, applies here, I think.