FDA - yes indeed. if the application is not close to being ready for filing, then heads should roll.
There is a lot of work in a PMA application, and apart from the final trial data everything else is known, so the prep work should have already occured.
If not, someone needs to be accountable. I would hope that Dr Cade has been driving this since Xmas when Heather (previous Reg) departed.
Sirt result, page-19
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