I know this is suppose to be a golf blog, but as many of you know I have made some recommendations in the past. Some have worked, and HSDT has been my one big black eye, but is HSDT dead money or is it time to re-think averaging your cost, or buying the stock now at $0.50 a share.
The management team at Helius Medical Technologies have made some mistakes, but in the end it came down to just one member of the FDA approval panel that thought more data was needed for approval. But was that conclusion really fair to the company and investors?
I say NO it was not fair, especially now that we have learned this same individual has been the lone blocker for other companies looking for approval. So what now?
I have learned much more about this company than I previously knew, and have a different view of it now as an investment. I’ll share just a few examples of this. I did not fully understand why Helius was originally targeted for MS not TBI. But when the Army funded a multi million dollar study on TBI, the company started in that direction as the Army was interested in its use for those in the Army with TBI.
But my original introduction to Helius was through Montel Williams at a dinner where he flat out said that the PoNS device had literally cured his MS, which now allows him to enjoy skiing and other activities he was not able to partake in prior to the PoNS device treatment. So why did the company go to the FDA with a TBI (Traumatic Brain Injury) application when clearly the MS market is much larger, and has a better chance at getting Insurance reimbursement?
The answer is they intended to get the TBI approval first and then quickly apply for MS. So when the TBI application was denied, the company had to pivot and look at the best course of action. The two links below are related to the upcoming application that will now be submitted for MS, not TBI and for good reason. MS is a degenerative condition and falls under the COVID-19 condition of “high risk” which is why the company has been granted a fast track approval process once the application is filed.
The data that will be used in this MS application is relatively old (from two small studies in 2011 and 2017), but the new data coming out of Canada is quite compelling (see bottom video which clearly shows the PoNS effectiveness)
So what happens now? The company will soon file its application with the FDA (the stock may rise a bit on this news) and then the FDA will fast track the application, which makes sense since they are already familiar with the device and have previously deemed it safe.
My bet is on Helius getting its approval, which will finally put the PoNS device into motion to help millions of people with not only MS and TBI, but many other neurological conditions as well.
The stock HSDT will either be ZERO, or somewhere north of $5 a share, and maybe even $100 one day after the product is rolled out globally. All of the patents and protections are in place, it will be a matter of commercialization and execution at that point.
One last thing to consider, I also learned that the PoNS device is far superior to the current leading drug that is used for MS. BUT this drug has a side effect of weakening the immune system, which during this period of COVID 19 is not a good idea to use.
I am a risk taker, this is currently a Canadian penny stock that typically has a slim chance of success. But after further investigation I believe this PoNS device will finally get its entry into a multi-billion dollar marketplace and make all of us proud. This is more about the woman in the video above, and the improvement in her life now after using the PoNS device. This product will help millions of people that suffer from MS.
I WANT TO BE APART OF THAT