Decision Diagnostics Corp (DECN)

[rawman]

Application was submitted according to PR to fda

Per CEO Keith Berman, the only application currently scheduled for submission is a PRE-EUA APPLICATION! A PRE-EUA Application has nothing to do with distributing a product. The Application is an "acceptance" to the facility of working with the FDA on things like product testing and clinical studies, which must occur before the FDA will approve a full EUA exemption. The following was copied from the FDA website:

About Pre-EUA

To help prepare for potential and current emergencies, FDA works with medical countermeasure developers to prepare Pre-EUA packages, when appropriate. A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation. The pre-EUA process allows FDA scientific and technical subject matter experts to begin a review of information and assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA in advance of an emergency and also helps to facilitate complete EUA requests during a current emergency declaration. Please note that a pre-EUA can only transition to an EUA if there is a current applicable emergency declaration.

DECN will likely submit an FDA application for a regular EUA approval, but it will not happen until further product development and testing has been accomplished. For the impedance-based kit, IMO, the EUA application might be transmitted in EARLY MAY!