Exploring the FDA review process will enable more remote conferences for company's like UEEC to upload and share data among a range of potential FDA questions. CEO Brian Thom had requested a remote conference back in October for just this purpose. " the company held a videoconference with the FDA on October 29. The purpose of the meeting was to present, discuss and seek feedback from the FDA on the company’s proposed resolutions to the deficiencies. Topics discussed include the company’s clinical testing (including the results of its human trial),
biocompatibility, product sterilization and shelf life. This meeting has provided the company with certainty on how to address the deficiencies,
with many of the issues already having been resolved." FWIW RCA (Regulatory Compliance Associates) has a podcast among other resources should you wish to broaden your understanding?
https://www.rcainc.com/webinars/medtech-and-p...istration/
Timing is everything! Look for an announcement by eom! Now we run!
$5-$10+