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02/20/23 2:17 PM

#157495 RE: CatfishHunter #157493

What progress? Still waiting for animal containment testing to start. 17 months and counting since MK forecast IDE submission.

Hard to see how they can hold off next offering after IDE approval, let alone submission, given there is no clear path forward to get there. Gotta keep the lights on in interim. Need to complete containment testing, write up and submit results, request meeting to get results reviewed. Only then might get green light to submit or FDA may suggest more follow-up testing.