In the spirit of pure speculation, I reckon news leaked on Friday, with the SP up quite noticeably and the response is a broad “Yes, we’re cool with it” but delivered in dour FDA language with caveats and checkpoints so the FDA can cover themselves in the event it goes belly up.
So I reckon it takes time to decipher the “I told you so” type conditions and language that will occupant all Ann from the FDA.
and it’s protocol to check with your consultants as due of due process.
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