On Aug. 14, 2020, Adamis Pharma announced that in response to its Pre-Investigational New Drug (IND) filing the FDA provided detailed comments regarding the prospective use of Tempol in a randomized placebo controlled trial.

The FDAﾒs response allowed Adamis to proceed to the next step of formally submitting an IND for Tempol, and at the same time, begin formal applications for funding to governmental agencies to support the clinical trial and large-scale manufacturing.