510 K for women requires a new clinical trial. This requires more time.
510K for Allay requires the completion of the clinical trial. Also, this device may require a predicate or they need to go Denovo. This is what they attempted to do in 2012. This requires more time.
The post operative will also require a predicate and could take even longer time and more clinical trials.
Their best bet is to focus on sale of current product, but this CEO is mot getting it. They need a new CEO. Nobody can or will last working with this guy. I expect the VP of sales to be out soon if the CEO is not changed.
The otc is run on share structure and news. ..Atrocious share structure and terrible news....The only way this bloated pig moves up is if there is a Reverse Split. ...
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