Replies to post #6878 on Arch Therapeutics Inc (ARTH)

[BooDog]

That's the problem with people setting stops on the way up and the way down. People that do that are usually not paying attention (sometimes at work/whatever) and their orders trigger. Not always the case of course, but adds to the support/resistance moves. Getting into the power zone so could see the momentum knock them right out.


Thinking we'll see that FDA news in a few weeks if not sooner.


FRAMINGHAM, MA -- (Marketwired) -- 07/25/17 -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel liquid, gel and solid hemostatic and wound care devices, today announced that the Company made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for its AC5™ Topical Gel on July 17, 2017.

If the Company's 510(k) application is cleared by the FDA, it is expected that the AC5™ Topical Gel will be used for external wounds. "This is an important milestone for Arch," said Terrence W. Norchi, President and CEO of Arch Therapeutics, Inc. "As previously shared, we planned to request 510(k) clearance in the middle of 2017 for the external use AC5™, which is a significant acceleration from original expectations of seeking U.S. regulatory approval through the PMA process, and we have met that goal. This achievement illustrates the ability of our team to execute on our development and regulatory strategies."

As previously disclosed, the Company still plans to seek regulatory approval to market other AC5™ products for internal use through the PMA process. Arch will continue to concentrate resources on the rest of its development and regulatory objectives. The Company is also working to scale up production and at the present time expects to have commercial product available in the second half of 2018. In the interim, Arch will continue to evaluate its commercialization options and it will provide further guidance as appropriate.

Dr. Norchi added, "This 510(k) submission, which incorporates recommendations provided by the FDA during pre-submission communications, is the culmination of the collective effort and success of our team in completing important biocompatibility, toxicology, preclinical, and clinical studies. Simultaneously, we continue to make progress on our preclinical pipeline, including several product applications with high unmet medical needs."