RE:RE:RE:RE:RE: FDA has refused request for approval of deviceIt is extremely easy to criticize in hindsight and label me as being intentionally misleading. Do as you please, I have no regrets sharing on this board. Being correct makes you look smart and being wrong has the opposite effect. However, the batting average of some of the world’s best investors is slightly north of 50%, so think about that before you let your emotions type on your keyboard.
The reality is that Helius has a large position for me (yes, I lost money on Thursday), for a long time, and all the due diligence I had done on the company, the device, the patients, lead me to believe this was a good risk/reward investment. I also shared a lot on this board, after receiving information from all the sources I had access to. Could I have not posted anything? Sure. But I decided no to. Now that the stock is down, board members hate for me for it. Had the stock gone up, they would have been thankful...
In any case, I agree that time is better spent understanding where we got it wrong and learn from our mistakes.
@dividendspay, you should reach out to Helius Medical directly and try to get your questions answered directly from them. Not trying to avoid answering your questions, but at this point I agree that management has to be held accountable for the decisions they made in terms of the trial design and FDA submission. Especially in the case of a therapy that is currently helping out dozens of patients in Canada, and changing their lives for the better.
Please state your source for the acceptance of this design.
- I was told by management, that the initial design (PoNS vs PT alone) was not accepted by the FDA in the pre-submission meetings.
- This led to the use of the sham device, which according to management, ended up providing a therapeutic effect.
- Now the FDA denied the approval, and is asking them to compare the PoNS to PT alone… This is what I find extremely frustrating!!!
- Especially, when patients were selected to have had their injury over a year ago and deemed to have plateaued in terms of PT gains…
- Again, this what I have been told in my communications with the company.
- I keep thinking that I might have been different had they kept a third arm, with PT alone…
I believe I cannot properly address your two other questions.
Will they likely need to release stock to raise cash? If so when?
How long is it going to take to do the physical therapy alone study (or whatever is needed) and get a, hopefully positive, response from the FDA?
- Company has to sit down with the FDA and propose different courses of action.
- The FDA might accept or refuse doing a single arm physical therapy study.
- How long… Who knows. Over 6 months, less than 24 months seems like a decent estimate.
Is EU and Australian approval going to be enough to make any difference?
- In terms of sentiment, most probably yes.
- Economically, depends how fast they can roll it out and execute on the strategy.
- I believe the best course of action is to focus on opening the 5 Canadian clinics as fast a possible and generating a steady stream of revenues.
- A good question to ask management, is can they be cash flow breakeven operating these five sites alone?
Is the future of this company likely positive or not?
- Not sure anyone can answer this question, but the FDA is a big disappointment.
Prokofiev
Dividendspay wrote: Just catching up on the posts.
I appreciate the tone prokiev: “Guess”, “I believe”, and “might” are more appropriate vis a vis your earlier firm and convincing, to some, posts.
Having said that, your comments regarding the design the FDA might accept are ,in my view, unfounded.
Please state your source for the acceptance of this design.
Can you state the power of said study without the historical controls, based on the Two armed studies already on record?
Can you provide an example where previous studies can be used to facilitate approval with the FDA?
(or were you thinking of using these in a network meta analysis ? If so can you provide some context and how this would be performed given the different designs?)