Arch Therapeutics Inc (ARTH)

[Ziptrader0]

I am wondering why the FDA would continue to allow the Class I-exempt listing for Arch on the FDA website (still there as of today). Dr. Norchi has been circumspect about why they listed as such, and he always says they are applying for Class II clearance. Almost all Class I devices are exempt from FDA clearance or approval. Norchi said at the LD Micro Conference “The Class I listing comes from an FDA database simply related to a company listing to be able to file your products with the FDA. You have to list your company with the FDA.” Actually, the FDA describes Registration and Device Listing as a notice to market a product that has been cleared or does not need clearance (termed PMN-Pre-Market Notification). I would not be surprised to see the FDA pull Arch’s listing, but worse, I am concerned that having made a possibly misguided and/or deceptive listing (my opinion) will harm Norchi’s relationship at the FDA at time when his being trusted is crucial for him to readjust to the current challenge. The loss of the listing could be the next shoe to drop. I am not suggesting you buy or sell shares of ARTH based on this posting. Happy Holidays and New Year!