2020 commercialisation, page-595

I read today an NXS ann which included:
"I am pleased to report that the testing required to complete our FDA filing and anticipated approval for our XPerience Surgical Rinse is progressing well.
We have had additional meetings and formal written notification from the FDA for the specific testing requirements and we expect to have the written reports back to the FDA before year end. We have strong confidence that with the submission of these reports we will have then met all of the FDA’s requirements for a 510(k) clearance of substantial equivalence leading to product approval and commercial launch in the 1st half of 2021."

What a contrast to RAP! Where is there even a hint, let alone substance, of the RAP progress (or lack of) from the early this year promised ongoing dialogue with FDA? Don't blame Covid - if NXS can do it, so can RAP. Or have I missed something?