Scott Gottlieb has been charged with modernising the FDA. The new FDA boss has already made inroads towards streamlining new drugs and therapies.
http://www.biopharminternational.com/fda-moves-overhaul-new-drug-review-process-2
I think that Biotron, and whoever partners the next stage of 225's HIV development will be pushing hard for things like treatment interuption programs and the like. No doubt it's a minefield, but things are changing.
Speaking of the FDA..... I wonder if there will be any concessions or fast tracking available for 225. Just another left field announcement that we might see as they start to converse with the FDA. Scott is a survivor of Hopkins Lymphoma (from memory) and has extensive gene therapy experience, he is a tremendous talent.
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