Ann: Trading Halt, page-65

FDA have been working around the clock on fast-tracking COVID-19 tests and related solutions.

IMO this will be a formal statement on the delay in De Novo submission assessments OR we have submitted a fast-tracked pathway as a developer of a respiratory diagnostic tool.

"We have since received over 100 requests for the template. Of those, 36 sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process. We are talking to them around the clock, and our door is open for any developers who want to have a test for use in the U.S."

Ref: https://www.fda.gov/news-events/speeches-fda-officials/coronavirus-covid-19-update-white-house-press-briefing-fda-commissioner-stephen-m-hahn-md-03072020 - March 7th 2020