Decision Diagnostics Corp (DECN)

[HFM2]

(Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency)

Based on the guidance from the FDA if the test is serology-based, Berman can start selling the kit as soon as it is validated (within 10 days from 4/23 + 7) and manufactured. He is required only to follow certain labeling guidelines and post certain information on the website about the validation.

If the test is not serology-based, the EUA and 15 day window apply, and if, in the EUA review process, the FDA finds a problem that cannot be addressed via an amendment to the posted/printed material "and the manufacturer has already distributed the device, FDA would expect the manufacturer to suspend distribution and conduct a recall of the test."

He is probably going the EUA route at the advice of the FDA (because the test was determined to be other than serology-based).