Arch Therapeutics Inc (ARTH)

[Ziptrader0]

Deja Vu? Arch’s FDA registration is for a Class I exempt device. Their recent 10(k)states explicitly they "have been determined to be Class II" If they don't change their registration from Class I-exempt, I don't believe they can get approval. Remember the fiasco earlier this year when they said the “wrong paperwork” was submitted to the EU for the CE Mark? Can't figure out what is going on with ARTH. Caution; Today may only be an oversold bounce, imo. The 510(K) is the real story and I don't see it happening anytime soon. Two possible erroneous submissions? How and Why?? My opinion, but I have asked a company that helps with 510(K) submissions and believe they agree.