Arch Therapeutics Inc (ARTH)

[Polyphemus]

Biosurgical devices are Class III & require a PMA for the specific intended use. ARTH has no preclinicaL & clinical trial data to satisfy the requirements. PMA occurs after a FDA review and a public advisory panel meeting by General and Plastic Surgery Panel, which has not been announced. This is most likely a red herring.

Interesting to note that ARTH knows that it will have revenue in 4Q, before end of 3Q, though "negotiations are continuing".

If the reported clinical results of annecdotal reports are "out of this world", they typically are. The bar for credible statements about ARTH is
getting higher.