Firstly,
@Justin De Moss, I would like to apologise if any negative experiences were had as a result of the previous posts. It was not my intention to attack you personally but rather simply discuss the matters relating to Hough Ear Institute's Pill treatment.
I think that part of the confusion around my incorrect claim that a drug could not be used off-label had stemmed from reading dodgy information and/or misinterpreting facts.
I had read papers which seemingly indicated that off-label use also included early access use. I later found out that this is wrong and not what the definition of off-label use according to the FDA guidelines is.
There is more data for hearing loss (cochlear implant trauma, NIHL, ototoxicity) than for tinnitus. It has nothing to do with confidence. The PoC study costs $735K. Oblato is paying for $300K of it, the state of Oklahoma is paying for $300K of it. That leaves $135K for us to raise for it. I'd say a lot of scientists are pretty confident in the work.
Your burning question is actually a false assumption - they are paying, for nearly half of it!
I wouldn't disagree with you that a lot of scientists are confident in the work.
What I would disagree with however is whether the "burning question" is a false assumption.
The questions around Oblato's confidence in the Hough Ear Institute's Pill treating tinnitus have been raised multiple times on multiple different platforms and by multiple different people.
I think that rightly or wrongly, the reason people questioned Oblato's confidence in the treatment is because they believed that the information disseminated by Hough Ear Institute to explain the reasons for needing to complete a proof of concept study for tinnitus and the reasons Hough Ear Institute needs to fund part of this study themselves have been confusing, lacking and also even contradictory at times. This has ultimately meant that they have felt that they have not got clear answers to these questions.
I think that these concerns about Oblato's lack of confidence in the treatment have been further supported and fuelled by the fact that there have been situations where people have misinterpreted what Hough Ear Institute has said. Also there have been examples of Hough Ear Institute needing to correct and clarify what they have said as well.
While I don't disagree that the more recently posted information indicates that the scientists are confident in the treatment and that the science supports this Pill delivering positive outcomes, this still doesn't seem to completely answer the two key questions of
- First, why does Hough Ear Institute need to fund part of the Proof of Concept study?
Since Oblato appear to be the sole financial beneficiary from the sale of the Pill and since scientists seem confident that the treatment stacks up, one can logically deduce that this should lead to Oblato being willing to cover the remaining costs of the proof of concept study. This is because Oblato will be the company who stands to financially benefit from the sales of this apparently successful treatment and should be able to recoup the costs of this study from sales.
and
- Second, why does a proof of concept study for tinnitus need to be completed when there is already more data and positive data to indicate that the treatment might pass trials for designations other than tinnitus?
Wouldn't it just be simpler and also possibly faster to have this medicine approved for one of the other designations and then simply just allow it to be used off-label for tinnitus?
I would also note, looking at the process from a business perspective, alarm bells ring and concerns are raised when I see something which on the face of it has an excellent business case and appears to be a solid product which is well supported by evidence, but yet does not have its development fully funded by the company who is ultimately going to be selling it. This is even more of an issue when there is a lack of direct and detailed information explaining why this is the case.
In relation to Hough Ear Insitute's Pill, this tells me one of three things:
- 1) A company other than Oblato is going to be benefiting financially from the sale of the Hough Ear Institute's Pill and this has not been clearly disclosed at this time.
For example, this could be Hough Ear Institute themselves or it could be the medical company that Dr. Kopke is currently the chair of.
Thus it could be interpreted that the reason Hough Ear Institute needs to fund outstanding costs associated with the development of the treatment (like this tinnitus proof of concept study) is because Hough Ear Institute is currently the undisclosed second company that will benefit from the sale of the treatment. Thus by contributing to the development, it enables Hough Ear Institute to retain part ownership of the treatment and therefore gain revenue from its sale.
- 2) Oblato has concerns about the effectiveness of the Hough Ear Institute's Pill for the treatment of tinnitus and as a result requires proof that this is effective.
There has been some further evidence given to alleviate concerns around the effectiveness of the treatment. However, the glaring issue still is why hasn't Oblato funded the outstanding balance for the proof of concept study for tinnitus if they are the ones who will financially benefit from its sale.
- 3) There is some unexplained reason or reasons why Hough Ear Institute's Pill needs to go through multiple trial designations for FDA approval (which includes tinnitus trials).
This is opposed to going through only one designation such as ototoxic medication treatment and then being used off-label for other possible uses such as tinnitus. There has been some further explanation as to why there needs to be a further phase 2 trial for tinnitus, however there is still no clarity as to why it must go down the full proof of concept study route, followed by the trial route for multiple designations.
I believe that all three of these concerns have also been raised at various points by multiple people when discussing the Hough Ear Institute's Pill. Thus I strongly believe that also addressing these issues will alleviate many concerns that people have had with the information provided in relation to the various aspects of the treatment.
FDA approval often leads to a fast track with other country's equivalent to the FDA.
Also, it fits in our mission. We can purchase the drugs and through our humanitarian efforts - deliver it to those in most need. Our founder and doctors have been to over 80 countries offering their services and medicine for free. But we have to have FDA approval first.
Yes, I am well aware that the medicine trials completed in one country usually lead to the medicine being approved in some other countries. I know that this happens with Australia and America and vice versa for example.
I think it's very likely they will.
Hough Ear Institute chose cochlear implant patients as their study population which means the study can't be carried out at routine ENT centers (like Pipeline Therapeutics and Otonomy) and would be way more subject to delays from COVID-19 etc.
I will let Justin De Moss answer this, although from what I have seen and what has been posted, it appears that the Pill trials are potentially getting done for multiple designations and not just the cochlear implant designation.
It also seems that based off of the information that has been previously posted about the clinical trial process that the pill might be taken through one designation or five designations depending upon what Oblato decides.
It should also be noted that I don't think that Hough Ear Institute is taking the pill through the trials at all and that Hough Ear Institute is not deciding what designations it should be trialled for either. Rather that decision is left to Oblato.