Arch Therapeutics Inc (ARTH)

[ap]

Like many others, since seeing the following link, I had been wondering why we hadn't seen any press release from ARTH.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=529643&lpcd=NAE

Clicking on the "Product Code" link indicates that AC5 w/out drug and/or biologic is "510(K) Exempt."

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5643

Since AC5 wo meds is 510(K) Exempt, ARTH would not have been required to file a 510(K). Since they've told us they filed one, this means that their application must refer to some other device.

https://ir.archtherapeutics.com/press-releases/detail/495/arch-therapeutics-announces-510k-submission-to-the-u-s

My speculation is that the 510(K) application we heard about from ARTH must have been for AC5 WITH drug and/or biologic.

Would ARTH have to submit multiple applications, one for every drug or biologic that AC5 might be combined with? Since their PR referenced only a single application, I assume they submitted only a single application. Would this allow the use of AC5 with any already approved drug or biologic? I speculate that ARTH's application consisted of research saying that the efficacy of a solution of X% of already approved drug M mixed in with AC5, is equivalent to Y% of drug M applied directly.

Regardless of the content of their application, I believe that the important point for investors is that the FDA has not yet responded to the 510(K) application that we read about on 7/25/2017.