Not at all twh... over the counter approval is about safety in the use of the product not effectiveness .... it is a sign that the FDA view the pericoach as a product safe enough for women to buy over the counter - and they essentially dont need specialist medical guidance or monitoring.
This approval would have no connection to clinical trials or the overall effectiveness of the product itself.
However it is still a very positive outcome for the company... these little milestones are nice but the only things that matter for us are sales.... or a licensing agreement. everything else is just noise!
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- News: ALT Analytica Ltd says FDA has granted co OTC clearance for PeriCoach system
News: ALT Analytica Ltd says FDA has granted co OTC clearance for PeriCoach system, page-8
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