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clock Created with Sketch. 21/12/23
10:09
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Originally posted by beefarmer:
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The absurdity of it all has been highlighted by the last two ASX announcements and by the absurdity, I do not mean BOT's approach, I mean the
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How this wasn't immediately considered a Class 1 resubmission with a 2-month review from the get-go is beyond me. There is no complicated data or potency assays to consider, no new trial results to analyse, it was a minor deficiency in labelling and a human factors study. (This may have contributed to the Class 2 but it's hardly a clinical trial - it was sponsor supplied data) Tick and Flick. 2 months. The FDA owe them that much for the BS CRL.
(20min delay)