Arch Therapeutics Inc (ARTH)

[NickHous]

Below copied and pasted from slide presentation 12/05/2017:


US 510(k): Class 2 device for external topical use
AC5TM Topical Gel filed July 2017
Targeted indication: Topical external dressing; partial and full-thickness wounds
Pursuing subsequent external use hemostasis claim after initial marketing clearance
Received and responded to clarifying questions from FDA, as expected
Expected timing for FDA response remains intact: 3-6 months from recent filing