Decision Diagnostics Corp (DECN)

[HFM2]

No, but I was not looking for that.

I was looking for process information, and what I got in response seems to be encouraging. First, in conversation with the FDA, I was told that basically for a product to get a pre-EUA authorization, it must have the possibility of succeeding, i.e. there must be something there. You cannot fake a pre-EUA number. The pre-EUA is not simply an "okay, lets get started - what do you have?" application.

It requires data as indicated by part of the response I got from the CDRH: "A pre-EUA (EUA) is generally the initial data and testing plans. We work interactively with the submitter. We do not review submissions prior to accepting (e.g PEUA). We assign number and reviewer and work from there. A PEUA does not guarantee an EUA authorization." Of course, we know the last statement to be true. No data, no plans, no pre-EUA.

Berman's language in the PRs (I reread them carefully today) shows a very clear path of development (even if his language is not always clear). The bottom line for the first pre-EUA submitted (The GenViro Pro model - only for professional use) is the request for "conditional approval" which will replace the EUA process. He stated on 4/23 that they had built the kits for testing (4/7) and had engaged a specialty reference lab to do testing, which was to start within ten days from 4/23 and be completed within one week. Therefore, the pre-EUA process for the Pro kit will not (likely) be completed before the suspension is lifted. However, the "conditional approval" may be granted before.