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03/05/23 6:26 PM

#158176 RE: wrinklesobw #158172

And that they had no controlled data on the 2021 version of Radiogel and no direct imaging showing Radiogel containment on any version of Radiogel.

On side note, I've always been amused MK calling the 8 reviewers "new". They were at the first meeting where the first draft IDE application was reviewed, so they were new since when? Can only guess he means new since the failed BDD application, where he burned a bridge with the lead reviewer?