Was there a pharmaceutical business playing interference with the FDA on this, remembering of course that somebody did the same thing with the TGA here? I would not be surprised if there was lobbying going on. It is the American way of business.
Were there personnel changes at the FDA along the way? I think the general view is yes and this may have influenced the decision.
FDA were under the pump because of Donald's shutdown. Loss of income is a major disincentive and staff were quite probably feeling negative about a lot of things.
So with the shutdown over, and the sorts of attention that a review meeting brings, together with fresh stats from the applicant, there is a chance that they will approve after all. This would save face given that the rest of the world has already given approval and sophisticated countries (like us) have approved it.
I suppose that their president ranting on about "America First" makes the distinct possibility that 30% of American woman will be last in the world has a sort of irony which their citizenry would not like.
SPL has at least followed advice and will not only have FDA experts and lawyers on hand but also BV opinion leaders with detailed personal knowledge of the trial execution.
FDA would have to be pretty stubborn (or stupid) to not approve. But then that mightn't stop them being both.
SPL Price at posting:
$1.04 Sentiment: Hold Disclosure: Held
(20min delay)
