Fact is RDGL has been put on slow track with FDA, likely because of MK's extremely slow responses and pissing off reviewers in meetings. MK's failed BDD application was back in 2020 and Jan. 2021. He entered IDE pre-sub program in Sept. 2021. Here we are 5 pre-sub meetings later in Oct. 2023. It isn't reasonable to expect same reviewers going back almost three years now. FDA is a busy place with no shortage of items to review. Companies like RDGL that are slow to respond and piss off reviewers, lose reviewers to more urgent assignments and are put on FDA slow track. Seems to me that is wise use of valuable FDA resources.
Like everything else in life, the fast squeaky wheel gets the grease. The slow vehicle gets neglected. Fact is all delays are on MK.
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