Decision Diagnostics Corp (DECN)

[pumper_stumper]

Great news! "FDA will no longer review LDTs under EUA for COVID-19 pandemic"

The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing.

The Department of Health and Human Services issued a rescission order in August, declaring that the FDA was not statutorily authorized to require developers of LDTs to go through the EUA program prior to practicing the test. The HHS move was not limited to the pandemic, however, and was backed by the argument that any such regulation mandated the use of the notice-and-comment process employed during rulemaking. A major drawback to that policy is that any products invoking the EUA process under the terms of the public health emergency enjoy immunity from product liability thanks to the Public Readiness and Emergency Preparedness Act. Conversely, any pandemic-related product that goes to market without an EUA enjoys no such protection.


Berman in a July PR stressed how expensive liability insurance would be already, and this just means that it's just going to get more expensive!!!

Mr. Berman concluded, "Finally, it is important that we recognize that the new FDA testing mandates places a huge strain on company resources. Testing is expensive enough, but the testing of infected subjects requires special insurance policies where the premiums are extreme".

Hey, what's few 10 million shares in additional dilution? I've never seen a DECN investor mind at the over 50% dilution this year, so let's dilute some more! It won't matter, right? lol

Of course, since they will never get FDA authorization anyway, it isn't going to matter, aside maybe for insurance for the testing, but I've yet to see a single DECN investor ever talk about financials. So, why would they care! It's not about profits, or understanding the science, or seeing through this madman CEO, it's about a pink sheet dream!

Anyway, great to hear this news! Yes, I AM enjoying DECN!

https://www.bioworld.com/articles/498693-stenzel-says-fda-will-no-longer-review-ldts-under-eua-for-covid-19-pandemic