HELIUS UPDATE – FDA DENIES APPROVAL

 All aspects of application were fine except:

They want the company to distinguish benefit from the device vs physical therapy alone.  This contrasted with previous guidance that the voluminous history of physical therapy alone over the past 50 years and the fact that all patients in the trial had exhausted physical therapy would stand as a control group.  That is why they were granted co primary endpoints of difference between high and low stim groups (just fell short of statistical significance) as well as a change from baseline (highly statistically significant).  The FDA bought off on the trial design and endpoints and even now is acknowledging no safety issues and overall excellent results.  Management will meet with the FDA to arrive at a consensus on how they can do a study to isolate the effect of the device.  One idea is to do a crossover study at the existing sites which continue to enroll patients in a clinical experience program.I’m told that 40 paying patients are being treated in Canada and doing extremely well.

I’ve understandably have received a lot of harsh comments which perhaps I deserve. What you learn when investing in these tiny cap stocks is they can go up 10-100x or they can go to ZERO. I have no idea where this stock goes now. I estimate the company has almost $20,000,000 in the bank and will slash costs. Will the PoNS device end up helping millions of suffering patients from all kinds of neurological diseases? My guess would still be yes.

Back to the point of small cap stocks- 18 months ago when I recommended LFVN at $3.50 a share, I knew it had zero chance of going to zero, and a great chance of going to $10. It went as high as $17. One comment was that I had a winner 10 years ago, but actually I’ve had two winners in the past 3 years. One that went up 400% and LFVN that went up at least 400%. I don’t get paid to give these stock ideas out, these are companies that I know and like. Will HSDT survive this? I am not sure, and with my account at Schwab down $250,000 today, I am still in shock at this news.

I will continue to provide updates to those of you that took my suggestion to buy Helius, a company that is helping people now in Canada, and hopefully one day the rest of the world. If you want to tell me how awful I am, please fire away as I have tough skin.

I hope to get back to writing about golf, and ways to improve your game. I sincerely apologize to those of you that this news and drop in HSDT has hurt. I hope that we all see better days for this company.

Anyone with a GOOD cure for the YIPS, I’d like to hear from you so I can share with the others.

Stay tuned, better days ahead!

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