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03/04/25 2:15 PM

#752466 RE: flipper44 #752452

flipper44,

Yes he said L might work but that the trial is so messed up they’ll need to run another one. That is his long standing “opinion” platform that the rest of his narrative is based on.. when not deviating too much; ). This of course conveniently “forgets” the pathway to approval through the “exceptions to adequate and well controlled studies” in FDA guidance which other regulators have been more than willing, it appears by their approval of the SAP and pediatric trial plan, to consider as well. Best wishes.