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Re: None

Thursday, 08/02/2018 7:08:28 PM

Thursday, August 02, 2018 7:08:28 PM

Post# of 10344
From 10-q issued today

- Dilution continues
- cash sufficient for operations till Q4-2019

The odd thing is - the sensitization trial will conclude in Q3-2018 and 501K will be submitted in Q3-2018 - that is too fast for any company much less for Arch - time will tell

“On June 15, 2018, the Company further announced that it completed enrollment for the human skin sensitization study and that applications of the Company’s AC5™ Topical Gel were underway for all subjects. The study is anticipated to conclude during the third calendar quarter of 2018.


At present, the Company believes that there are no other material items to address with the FDA. Assuming supportive study findings, the Company expects to file the 510(k) notification in the third calendar quarter of 2018. That 510(k) notification would contain both the information previously reviewed by the FDA and the additional data discussed with the agency.