Biotech 2k view of drp results | ACAD Message Board Posts

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Msg  16121 of 16315  at  12/7/2019 2:14:42 PM  by

good_investor93


 In response to msg 16119 by  jim_pd
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Re: Biotech 2k view of drp results

"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.
 
Of course, the FDA will have the final word. ACAD investors have little to worry about here.
 


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