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10/02/23 8:47 AM

#166685 RE: Bangkok Bob #166681

That would be leading the the "new" reviewers to the conclusions of others vs. an independent review. The shame is on MK for not responding to FDA in timely fashion (TKAD) and/or pissing off prior reviewers blaming them for delays, making baseless comparative performance and safety claims, etc.

MK even cited this "new" reviewers nonsense at 1st pre-sub meeting almost two years ago in Nov. 2021. "new" since when? The failed BDD application when he pissed off FDA posting unredacted email with lead reviewer's contact info?

Now he's again citing this "new" reviewer nonsense over two years after entering the pre-sub program in Sept. 2021. Not FDA's fault MK took over a year to respond to FDA comments from 1st meeting and likewise took over a year to commence the controlled animal tests that should have been done years earlier.