Thursday, November 16, 2017 2:00:44 PM
“Medical devices in the EU and the U.S. are classified along a spectrum. Class III status, which is the higher-level classification for devices compared to Classes II and I, involves additional procedures and regulatory scrutiny of the product candidate to obtain approvals. AC5 could be regulated as either a Class III or a Class II medical device in these jurisdictions, depending upon the application, subject to the process for obtaining a CE mark in the EU and the premarketing authorization process in the U.S. It has been determined that our AC5™ Topical Gel used for external wounds will be a Class II medical device.”
So, if the AC5 Topical Gel is approved and begins commercialization before Q4 2018, when the cash on hand will be depleted requiring financing/dilution, then ARCH will be in great shape going forward. This is just my opinion.
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