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boi568

08/15/20 2:49 PM

#265429 RE: falconer66a #265428

I completely agree with your analysis, falconer.

However, I doubt that this thoroughly back door route to Australian approval would move the FDA to approve 2-73 for AD without a blinded, placebo-controlled trial. Whether that can happen after a PDD trial success is an open question IMO.
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rayovacAAA

08/15/20 2:51 PM

#265430 RE: falconer66a #265428

LINK TO ANY OFFICIAL TGA DOCUMENTATION CONFIRMING THE ACCURACY AND CONTEXT OF THE BELOW STATEMENT????????


.around 75% drugs eventually get approved after SAS, unless there are safety concerns while under SAS.