FDA Approval ? Posted by Seaheck: Non-inva
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Posted On: 12/15/2017 1:14:03 AM
FDA Approval ?
Posted by Seaheck:
Non-invasive + Fast Track means FDA approval for use in 2-3 months. Endonovo will just have to report any adverse side effects.
This is NOT a multiple year approval process, like you say. Should easily have approval for use by late Q1 2018 to early Q2 2018.
A portion of the FDA request process has already been set in motion, just not announced. I know exactly how long it takes and what happens next. You can use/sell your device even with FDA trials still going on, with a specific FDA exemption. So there are many options. We won't have to wait years before we can utilize the FDA trial approval is all I'm saying.
I have just verified this post to be true. Very short turnaround once we start.
Seaheck Wednesday, 10/11/17 12:16:41 PM
Yeah, I'm not talking about the news coming up (pre clinical).
I already know that those results were successful. I'm talking about the next step in the process which are the FDA trials.
It will take 3 months to get approval and then Endonovo can market and sell the device. We then have to report any adverse side effects that come up, if any, from people using the device. Endonovo has to report those to the FDA via the FDA adverse events reporting system. As long as adverse events remain within the range allowed by the FDA, our device continues to be marketed and sold. Because it's non invasive and due to the components used to make e device, the side effects/adverse events will basically be non existent/bare minimal.
Posted by Seaheck:
Non-invasive + Fast Track means FDA approval for use in 2-3 months. Endonovo will just have to report any adverse side effects.
This is NOT a multiple year approval process, like you say. Should easily have approval for use by late Q1 2018 to early Q2 2018.
A portion of the FDA request process has already been set in motion, just not announced. I know exactly how long it takes and what happens next. You can use/sell your device even with FDA trials still going on, with a specific FDA exemption. So there are many options. We won't have to wait years before we can utilize the FDA trial approval is all I'm saying.
I have just verified this post to be true. Very short turnaround once we start.
Seaheck Wednesday, 10/11/17 12:16:41 PM
Yeah, I'm not talking about the news coming up (pre clinical).
I already know that those results were successful. I'm talking about the next step in the process which are the FDA trials.
It will take 3 months to get approval and then Endonovo can market and sell the device. We then have to report any adverse side effects that come up, if any, from people using the device. Endonovo has to report those to the FDA via the FDA adverse events reporting system. As long as adverse events remain within the range allowed by the FDA, our device continues to be marketed and sold. Because it's non invasive and due to the components used to make e device, the side effects/adverse events will basically be non existent/bare minimal.
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