Ann: FDA Strategy and Regulatory Update, page-489

So, late night recap of where we're at:

Material agreement with Compass for Ilumen, DONE

MEB-001 - denied initial application for breakthrough device. Company can - and I would hope, will - challenge this decision. However it does n ot affect the device itself or the trials it will undergo in 2021

MEBSLEEP - FDA 510(k) decision due any day now, but could also be on the new year. Depends when FDA finish their substantive review. Important to note that this was not what the company said would be released around the 30th - that was released today. HOWEVER we can take from that that the FDA seems to be running fairly to time now, as opposed to during covid when it took longer than usual to get MEBSLEEP from the initial acceptance to the beginning of the substantive review process.