Hey Hercepin,Day 15 appears to be an absolute line in the sand...

Hey Hercepin,

Day 15 appears to be an absolute line in the sand for FDA processes. So, is it fair to assume it has been accepted for Substantive Review?

If not, would notification of RTA Hold - Refusal to Accept - be a material event requiring disclosure?

Reading through the FDA RTA guidelines, it's hard to imagine either CC/CardieX + Andon getting anything wrong - in his many presentations Craig comes across as an absolute perfectionist for detail.

It's an interesting read:

https://medicaldeviceacademy.com/refusal-to-accept/

If CardieX/Andon have been notified of Acceptance for Substantive Review, is it something we should/will get an update about - maybe in the Q?

Perhaps that's what Craig was having some fun with on LinkedIn re the Buffet quote...

PA remains positive, no hints of anything amiss.