I think folks are overstating the importance of the “formal” response from the FDA. The company apparently has had a number of (ongoing) engagements with the FDA and sort clarification etc.
What if the formal response from the FDA is basically directional, lacking in specificity. In other words - the company must attain x but doesn’t detail how specifically it does that.
The proof is when the clinical hold is lifted. And it’s not like the incumbent political regime are allowing agencies to operate consistently and without intervention on a whim! RFK jr is supremely qualified so we are in great hands. ffs!
i look at it as if i get a fine notice. The fine tells me numerous ways to pay them but not how to get the money to pay them. It also states avenues to defend against the fine, but not help me whatsoever on specifics for my case that would help me attain my fine being lifted.
The side line clarifications and guidance are far more valuable.
I’m more excited that they got a CFO then also took him to the USA. This is far from trivial. Boffin is right IMO, something is cooking.
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