Change thanks, can you clarify the fda class1 status, i understand from your post that it wasnt filed at all??
So actually we dont wait for aproval as we all thought we are waiting but only for filing..
Change thanks, can you clarify the fda class1 status, i understand from your post that it wasnt filed at all??
So actually we dont wait for aproval as we all thought we are waiting but only for filing..
that's the way it looks ...
And, as I understood the update and prior Lifeline PRs, the success of the clinical trials should allow them to get Class 1 FDA fast-track clearance without filing, right? If they'd only wrap up that nugget. I looked back at the 2016 forward-looking PR on OTCMarkets, which said: "This on-time achievement adds value and validates the Cyrcadias ability to get through the developmental and regulatory efforts required to bring this important lifesaving technology to market. Year 2016 expectations are that the clinical trials will be completed, the regulatory filings will be achieved which is intended to lead to clearance by the FDA of the 510(k) application and CE Mark authoritative body. Additionally, the Company and Cyrcadia have begun exploring prospective alternative strategies that could accelerate increased value and liquidity." Hurry up and wait...