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regalmanor

03/25/17 10:07 AM

#5913 RE: NickHous #5912

Per the 2/16/2017 PR, "Arch is maintaining current guidance regarding its aim to file a CE Mark for AC5 Topical Hemostatic Device™ as soon as possible and is continuing to work with its third-party partners to prepare requisite materials for submission to regulatory authorities. As previously stated, the planned 2017 regulatory filings would be the company's first, as there has not yet been a submission for approval of AC5 to any regulatory body".

21money21

03/25/17 11:46 AM

#5914 RE: NickHous #5912

No they don't have a specific date, they are talking about htgm and how it took them 2 1/2 months from file date until approval