Ya, I was incorrect about IDE submission in 1st quarter 2023. Obviously that is no longer in the cards. But must note that forecast was among the more pessimistic forecasts on this forum. mc73 has best track record on IDE submission forecasts so far.
RDGL still facing strong headwinds and the anchor of MK's incompetence dealing with FDA. My comments reflect that reality.
Will remind I was strongly ridiculed here in 2021 and 2022 for pointing out that the 2021 polymer "improvements" meant starting over with FDA. Per the last update, the required bio-compatibility tests on that new polymer are an IDE requirement, were the most expensive tests to date for RDGL and were only completed last month.
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