RE:my take away's from the conference call. I'm sorry but I got a different take.
A) They did not address how the US FDA rejection may (or may not to be fair) effect sales and distribution in Canada (how many clinics & patients will sign up)
B) Information regarding what the FDA wants or needs was presented to the sharehlders anecdotaly by Phil Dechamps and did not touch on specifics. The shareholders have not seen or read anything precise as to FDA needs or wants and will likely not ever know because it is an internal proceedure.
Remember, HSM had multiple collaborative meetings with the FDA prior to submission.....and then still failed.
C) FDA is agnostic as to collabrative meetings. All companies have that ability and they all do....its part of the process. To suggest that this is great for HSM is misleading.
D) Shareholders were not told what the "monthly sales" were and how many new clinics are being signed up, particularly when the news is out that HSM failed its US FDA clearence for the treatment claims. They did mention that they are working towards a " cost reimbersment" treatment model (workmans comp, auto insurance etc) however, that will take a very long time, if ever.
My conclusion: The share value risk continues to be very high at this point and there are simply too many things that need to happen for the share price to garner broad support, particularly institutionally...
Swedeprof wrote: 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