Going back to ol' mate LDX and its blindsided approval in July this year, maybe there is an opportunity for a quicker submission and/or approval. I realise that LDX's was a medical device and the rejection might've been Cat 1 but their investor presentation said in March this year :
"Following presub meeting, planning to file second 510(k) with FDA during CY2023".
4 months later they get approval with not a word announced to the market beforehand.
Sorry to include this in the BOT thread but Howie's 3-6 months could have some merit. As with LDX, a lot can happen in the background that we don't hear about.
New Hartley Analyst report on Bot, page-63
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