Arch Therapeutics Inc (ARTH)

[VMLG17]

I agree. I read the section of the text several times, and I don’t see any evidence of Class I exempt status in the U.S. I interpret the 10-k to state that the AC5 Topical Gel is Class II in the EU and US and that the other AC5 products’ classification has not been determined yet in either location. I’m referring to the following paragraph from the 10-k:
“Medical devices in the EU and the U.S. are classified along a spectrum. Class III status, which is the higher-level classification for devices compared to Classes II and I, involves additional procedures and regulatory scrutiny of the product candidate to obtain approvals. AC5 could be regulated as either a Class III or a Class II medical device in these jurisdictions, depending upon the application, subject to the process for obtaining a CE mark in the EU and the premarketing authorization process in the U.S. It has been determined that our AC5™ Topical Gel used for external wounds will be a Class II medical device.”
So, if the AC5 Topical Gel is approved and begins commercialization before Q4 2018, when the cash on hand will be depleted requiring financing/dilution, then ARCH will be in great shape going forward. This is just my opinion.