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Monday, July 13, 2020 4:22:37 PM
"According to a report from the agency, the average PMA application is approved 243 days post-submission. That’s just over eight months."
PMA submission was completed in November of 2019. As of today, we are just now approaching 8 months since submission. We are right on schedule... Add into that possible/probable COVID delays I'd guess that may push approval a month or two back. We are getting very close. If you can't stomach some turbulence you shouldn't have bought a penny stock in the first place.
P.S. From the same article (posted in 2019) "Currently, 92% of PMA applications are approved by the agency." I like those odds.
https://www.qualio.com/blog/fda-medical-device-approval-process#:~:text=process%20to%20take.-,How%20Long%20Does%20the%20FDA%20Medical%20Device%20Approval%20Process%20Take,is%20not%20a%20fast%20process.
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