Ann: FDA Strategy and Regulatory Update, page-331

If you have held till now, I encourage you to hold for a few more weeks. I expect to see a few updates in the coming weeks.

1. FDA 501k approval for MEBsleep

Substantive review start = 24/08/2020
45day timeline = 08/10/2020
I suspect the company is providing answers to queries from the reviewer and an ANN that the application has been accepted for Interactive review (30day review) or that application is approved may be released soon-ish. I understand the Interactive review could be a series of phone calls and correspondences to provide some clarifications.

2. CE Mark application for MEBsleep

30/08/2020 - Technical file for MEBsleep submitted (Step 5 below)

3. MEB001 FDA Breathrough Device Designation (60day process)

Submitted application = 02/10/2020
Approval = 01/12/2020

4. Other Anns regarding Ilumen and software app development.

At MCAP of about $16m, it's not impossible to trading at $64m by Christmas based on peer review. Am I missing something here?

DYOR