my take away's from the conference call. My take always from the HSM Helius conference call yesterday:
1. surprisingly STRONG revenue for 2 clinics in 1 quarter.
2. FDA acknowledges improvement but want additional information
3. Helius is in the process of obtaining additional clarity on what FDA is looking for.
4. FDA wants to work with Helius and suggested pre-submission meeting
5. As a result of FDA delay, Helius has reduced work force by over 30%. They have maintained all infrastructure though. (This is excellent as their loss was higher because of the expected USA market entry)
6. Submitted for Europe CE mark Q4 2018
7. Submitted for Australia regulatory approval May 9th (yesterday)
8. Clinic in Canada are ordering devices monthly. This is fantastic as constant revenues will be coming in and growing month over month as they plan to add another 3 clinics (currently just 2) by the end of 2019