Frequency Therapeutics — Hearing Loss Regeneration

[dmorg]

LOL you don't know that.

LOL WUT?
Maybe they could ask one of the 16 people?

And uh, yeah they can measure hearing levels in mice. Here's the study where they successfully restored hearing in mice with the same technology.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3573859/

Stop spreading ignorance, it's contagious.

How about speech discrimination? Which is a whole lot more important and complex than just hearing sounds. I pray they found some level of success in restoring the ability to hear sound and understand the spoken word. You can't test that on a mouse (pretty sure) which is my point. They claim not to be testing efficacy this go round just safety. Wish I could ask a participant what they think.

 

[Paulmanlike]

@Ed209 Do you still invest in biotech "start ups"?

Would you invest in Frequency Therapeutics if it was public? What are your thoughts on CRISPR biotech's? One to watch.

However Otonomy being the only PLC, I am holding back for now being so early.

 

[JohnAdams]

restoring the ability to hear sound and understand the spoken word.

it's called hearing loss restoration.

 

[Johan_L]

They claim not to be testing efficacy this go round just safety.

"The primary focus of the study…is safety in a patient population with confirmed stable sensorineural hearing loss. However, the measurements we are using to assess safety are the same type of measurements that we'll be using to assess efficacy in future studies, but there are no efficacy endpoints in this trial. Hearing improvement is not a goal of this study."

https://www.in-pharmatechnologist.c...ight&utm_medium=OnSite&utm_campaign=copyright

They are testing Safety, but measuring Safety is the same as measuring Efficacy in this case. They will likely report hearing thresholds as that is part of the safety measurement. Something like "No patient had a reduction in hearing thresholds (= it is safe). The thresholds improved from baseline avg. by X dB."

They will however not claim that the drug improves hearing, not until it is proven in more trials.

 

[Johan_L]

@Ed209 Do you still invest in biotech "start ups"?

Would you invest in Frequency Therapeutics if it was public? What are your thoughts on CRISPR biotech's? One to watch.

If you believe in Frequency Therapeutics but cannot invest because it's not a PLC, you can short the hearing aid companies instead as Frequency Therapeutics will put them out of business.

 

[Ed209]

@Ed209 Do you still invest in biotech "start ups"?

Would you invest in Frequency Therapeutics if it was public? What are your thoughts on CRISPR biotech's? One to watch.

However Otonomy being the only PLC, I am holding back for now being so early.

No, Paul. I spent years trading stocks and my main speciality was mining and oil companies on AIM. Although I traded on other markets as well and many other different types of stocks. Me and a mate of mine did well, but I made a stupid error that annoyed me for quite a while. I was invested in a share called Sirius Minerals (SXX), did all the research, met some of the directors at an expo and bought around £12,000 worth at an average of 4p. I saw it as a 'sure thing' and it was one of my main stocks in my portfolio for over a year. In the meantime I was daytrading other shares and was making good money here and there. Then came a stock called Rockhopper, which was recommended to me by a guy I know who has worked all over the world on big projects, and he was told by some oil tycoons that they reckoned they would hit black gold in the falklands. With this I took a gamble and bought £8,000 worth of shares. The story that's about to follow is why we should never chase success.

I happened to come across an interview on the radio and it was some of the original people from Shell who had already explored this basin years before (the chance of me hearing this interview was incredibly small, but somehow I did). I knew about the Shell drills, but this interview really put me off as they were convinced that it was going to be a duster, and so, I sold £7000 of my holding in the middle of the big drill. I felt it had become too much of a casino gamble. My friend however, kept his full holding. Two days later - bearing in mind I held this stock during the entire risk period as the results could have come at any moment - the RNS came through and it was the jackpot. They had found more oil than they expected and it was all amazing. It even made the front page of The Sun newspaper. The stock went from 30p to £5 and I had an £8000 holding at an average of about 40p before I sold my stake down to £1000. To say I was pissed off and gutted is an understatement. In the meantime my mate was making over £150,000 and it was rising in real-time; I wanted some of the action as it was still rising and this is where I messed up. I sold a huge chunk of my SXX shares to chase the rest of the Rockhopper rise. I made money on it, but then not long after (and you couldn't write this) SXX had their big RNS and it went from my 4p average to over 40p. I thought you're killing me!!! Although I'd made thousands I'd ultimately missed out on life-changing money. To have it for over a year and to be emotionally involved, to sell it on a whim and to chase something else missing the payoff really got to me. I missed both of them.

Back then I was The General82 on the iii forums, now it's called ii. I did alright out of it, but my mate did really good. He easily made over £300,000 then he bought some properties to rent out off the back of it.

The guy who told me about rockhopper was always big on the biotech companies and to be fair we often shared info on stocks that were mutually effective. I ain't been in the game for years now as I'm mr family man, but it was a wild ride whilst it lasted!

Sorry for the off topic post.

 

[RB2014]

Of course they do amplify and help you hear but this probably causes more damage over time at high volume (Catch 22).

This is only true if you have them turned up to high or you are in places that are too loud. If you set your hearing aids correctly then they actually help keep you from losing your hearing over time. Think of the hair cells as muscles. If at 8 kHz you aren't picking up anything and stimulating them they die off faster. If you stimulate them by amplifying 8 kHz then they do not die off as quickly. If you need a hearing aid you should wear it. They kept my tinnitus at bay for 42 years by correcting the frequencies I was deficient in. If not for anxiety I would be one of the people with extreme hearing loss and no tinnitus.

Right now Frequency Therapeutics is our best prospect at regaining hearing and either lessening or getting rid of tinnitus. Let's hope for the best.

 

[Enclave]

This thread is going off on an extreme tangent. Unfortunately, I'm going to contribute an opinion that feeds into this against my better judgement. Please feel free to flag this and have it removed for being slightly off topic.

Here's my current thought on FX-322 and it's competition: who is Frequency Therapeutics's biggest competitor?

Answer: Decibel Therapeutics

For the longest time Decibel Therapeutics was quiet about their pipeline, and to some degree they still are now. To date, Decibel Therapeutics has brought in more funding and have opened up new fancy labs in the heart of Boston and do a great job of looking the part. Recently, Decibel Therapeutics revealed some of their short-term pipeline candidates to the public. Anyone here find it interesting that they abandoned hearing regeneration in the short-term? Their earlier claims stated that they were looking to restore hearing, protect hearing from ototoxic agents, and to develop other therapeutics for various other ear maladies. The fact that their current pipeline has nothing to do with hearing regeneration is a huge sign that they've waived the white flag to Frequency Therapeutics. They have Albert Edge on deck, who was part of the infamous 2017 paper Frequency Therapeutics dropped, and to me they had serious business reasons to not pursue hearing generation due to the potential of FX-322 and how far ahead Frequency Therapeutics was in the regeneration game. If Decibel Therapeutics felt like FX-322 was fallible enough in nature, then they would have placed their precious resources into coming up with their own hearing regeneration drug, but they didn't.

Biotech lives in a world of finite resources and high probability of failure. Decibel Therapeutics is one of the most knowledgeable companies out there in hearing biology and they're currently not trying to compete with Frequency Therapeutics in the hearing regeneration race. This is fascinating to me. This tells me that they also have reason to believe in the efficacy of FX-322.

Also to note on the hysteria of FX-322, it's important to note that Frequency Therapeutics is truly a Unicorn in this area of biotech and hearing loss biology as a whole (I hate to use that metaphor). You can't compare Frequency Therapeutics's technology to that of any previous company. They're on an island right now with their technology and their approach. There is no one else like them currently, and no one else like them previously. You can't compare them, period.

This is the best shot we have right now and there is reason to be optimistic about it. Even the fact that they are still privately funded is a good sign. They're not stock pimping to gain further funding, which loosely eludes to their confidence that what they have might have impact. If you're sure of your technology, why have more hands in on the reward?

And don't start in on Acousia or Audion as competitors. Their drugs are different, their technology is different, their mechanisms for hearing regeneration are different, and they can't be compared to Frequency Therapeutics.


We're close people. We truly are. If Frequency Therapeutics fails, so be it. At least this was a substantially huge step forward in hearing regeneration biology and there will be something to learn from this going forward.

Outside of this, we have nothing. All we have are devices and mind retraining therapies... AKA bullshit.

 

[d'Wooluf]

Hey @katri. I don't know if I'm one of those negative people you mentioned. If so, I apologise. I might look for that button you mentioned.

I think Frequency Therapeutics is exciting. I was told by my ENT that there was no possibility ever of a cure for sudden sensorineural hearing loss, so the knowledge that there's a possible treatment being trialed makes me happy. The crucial difference is that I live in hope, not expectation. I hope it happens for my own sake as well as yours and JohnAdams.

At the same time, I think that people should be encouraged to pursue every available treatment or behaviour modification that is available now to make their lives better. Learning to live with tinnitus is a worthy goal right up until the moment a cure is found. If and when FX-322 becomes an available treatment, we can all celebrate.

 

[d'Wooluf]

Also to note on the hysteria of FX-322, it's important to note that Frequency Therapeutics is truly a Unicorn in this area of biotech and hearing loss biology as a whole (I hate to use that metaphor). You can't compare Frequency Therapeutics's technology to that of any previous company. They're on an island right now with their technology and their approach. There is no one else like them currently, and no one else like them previously. You can't compare them, period.

Not sure I agree. If you're talking about the general approach of activating supporting cells so that they turn into or produce stem cells, I seem to constantly run into stories about startups/labs working on this. If you want me to produce all the names I probably can't. Anyway... There's Audion/Regain Project, Hough Institute, a company based in Holland whose name escapes me, a researcher at the Rockefeller Institute whose name I can't recall (he recently won a major award for biochemistry)...

Frequency Therapeutics is furthest along the pipeline. None of what they have done happened in isolation. It's based on earlier work and other scientists are taking that work forward in different directions. It's all good news in my opinion.

Edit: Just saw your note on Audion. Are they that radically different? It's still harnessing plasticity in supporting cells. Doesn't matter really. It's not like you have to pick a horse to bet on.

 

[Street Novelist]

I understand this is a trial for safety, but they will still know if the drug works by the end of the trial. The people who received the drug will either have their hearing improved or not.

If it works, I just don't understand why they would need another trial? They would know it's safe and works.

 

[katri]

Hey @katri. I don't know if I'm one of those negative people you mentioned. If so, I apologise. I might look for that button you mentioned.

I think Frequency Therapeutics is exciting. I was told by my ENT that there was no possibility ever of a cure for sudden sensorineural hearing loss, so the knowledge that there's a possible treatment being trialed makes me happy. The crucial difference is that I live in hope, not expectation. I hope it happens for my own sake as well as yours and JohnAdams.

At the same time, I think that people should be encouraged to pursue every available treatment or behaviour modification that is available now to make their lives better. Learning to live with tinnitus is a worthy goal right up until the moment a cure is found. If and when FX-322 becomes an available treatment, we can all celebrate.

Personally, I enjoy your criticisms because you bring up relevant points about the flaws in Frequency Therapeutics. There are times when I feel like the way you say it is a little harsh. But for the most part I only have problems with people who start attacking individuals or predicting things they could never know.

Some people actually live for this research. They view Frequency Therapeutics as their only way out and that's dangerous. That being said, it's better than living for nothing. When people say bold things like "never" and start insulting people that genuinely rely on this treatment, I take offense. It's the same with religion. I don't care if you believe or not. If someone's life depends on it, don't dismantle their faith.

 

[JohnAdams]

"The primary focus of the study…is safety in a patient population with confirmed stable sensorineural hearing loss. However, the measurements we are using to assess safety are the same type of measurements that we'll be using to assess efficacy in future studies, but there are no efficacy endpoints in this trial. Hearing improvement is not a goal of this study."

https://www.in-pharmatechnologist.c...ight&utm_medium=OnSite&utm_campaign=copyright

They are testing Safety, but measuring Safety is the same as measuring Efficacy in this case. They will likely report hearing thresholds as that is part of the safety measurement. Something like "No patient had a reduction in hearing thresholds (= it is safe). The thresholds improved from baseline avg. by X dB."

They will however not claim that the drug improves hearing, not until it is proven in more trials.

So basically they will know but keep it a secret.

 

[JohnAdams]

I understand this is a trial for safety, but they will still know if the drug works by the end of the trial. The people who received the drug will either have their hearing improved or not.

If it works, I just don't understand why they would need another trial? They would know it's safe and works.

To be fair they probably will need to test frequency ranges and thresholds etc. For instance it may be really great at restoring high frequencies and incapable of getting to the low frequency parts of the cochlea. They could certainly test that pretty quickly. At least much faster than they probably will. Let's just hope that Will McLean ﷺis successful.

 

[Ed209]

I understand this is a trial for safety, but they will still know if the drug works by the end of the trial. The people who received the drug will either have their hearing improved or not.

If it works, I just don't understand why they would need another trial? They would know it's safe and works.

One of the big issues is long-term safety data. If they were to release it early they would need a 'conditional approval' or 'accelerated approval' at the very least. Frequency Therapeutics could then be exposed to litigation later on if it turns out there's a safety issue further down the line. From what I've read they would need a 'safe harbor' provision to protect them from product liability suits.

These are only usually given out in extreme circumstances; for conditions or diseases that are fatal, for example. That's not to say it's not possible, but would Frequency Therapeutics realistically take this route? Also, sometimes it's cheaper for the company to take their drug into phase III, meeting all of the regulations. I'm not sure how a conditional approval would affect them financially, in this case, but it's another thing to think about.

Remember, they are a business, so it's unrealistic to think they would take unnecessary risks unless they had a protection order in place and it benefitted them financially.

There's a lot more complexity to this than some people seem to realise.

 

[JohnAdams]

"The primary focus of the study…is safety in a patient population with confirmed stable sensorineural hearing loss. However, the measurements we are using to assess safety are the same type of measurements that we'll be using to assess efficacy in future studies, but there are no efficacy endpoints in this trial. Hearing improvement is not a goal of this study."

https://www.in-pharmatechnologist.c...ight&utm_medium=OnSite&utm_campaign=copyright

They are testing Safety, but measuring Safety is the same as measuring Efficacy in this case. They will likely report hearing thresholds as that is part of the safety measurement. Something like "No patient had a reduction in hearing thresholds (= it is safe). The thresholds improved from baseline avg. by X dB."

They will however not claim that the drug improves hearing, not until it is proven in more trials.

I think they are actually doing a private human efficacy study under the guise of a safety study to save money. Just to see how to move forward.

 

[Johan_L]

So basically they will know but keep it a secret.

What do you base this on? What I am reading in their statement is that they will be transparent with shifts in hearing thresholds. The purpose is to prove that it is safe and that there is no loss of hearing.

I expect them to show any shifts in hearing, even improvements. An improvement is an even stronger indication that the drug is safe for hearing. Right?

 

[Ed209]

An interesting article that's worth a read. I'll post an excerpt below:

The Issues With Accelerated Approval

The FDA's accelerated approval of eteplirsen, a new antisense drug for Duchenne Muscular Dystrophy (DMD), is a clear example of both problems – "astronomical prices" and accelerated access. DMD is a devastating illness that affects children and causes muscle weakness and eventual death. There are no effective treatments. Understandably there was enormous pressure from patient groups to approve the drug despite the lack of evidence that the drug actually works, beyond a change in a surrogate marker.

The drug is now available at a price of $300,000 per patient per year, but it may be years before the data from additional clinical trials can provide substantial evidence of whether or not the drug is effective. If the drug turns out not to provide meaningful clinical benefit, then the $300,000 per year cost of providing patients the drug is a terrible waste of our health care dollars. However, if insurers do not pay for the drug and it actually would provide significant therapeutic benefit to Duchenne's patients, then there would be even more terrible unnecessary suffering and death among DMD patients.

Eteplirsen is not by any means the only drug approved before the real risks were known or, in some cases, a lack of real efficacy was demonstrated. One useful model for accelerated access and controlled pricing was developed in response to an earlier era of crisis in pharmaceutical policy when the HIV epidemic first caused a public outcry for accelerated access. Prior to the AIDS crisis of the 1980s, major patient advocacy groups, such as the American Cancer Society and the American Heart Association, focused their efforts on raising money for research and paid virtually no attention to the FDA. With AIDS, and particularly with ACT UP (AIDS Coalition to Unleash Power), the world changed. For the first time there was enormous pressure on the FDA to do something—anything—to get drugs out to patients before all of the safety and efficacy data was in.

The FDA responded to the AIDS crisis with a number of efforts to expand early access. One that has the most relevance for today was the 1992 parallel track initiative. The parallel track initiative, was used only once for stavudine, a still-experimental drug that was made widely available to physicians treating AIDS patients. The drug sponsor could seek to charge for the drug but only in an amount sufficient to recover its costs for the trial, which required financial disclosures to the FDA. Treating physicians providing the parallel track drug were required to provide the sponsor with basic data on their patients and patients' responses to treatment.

https://www.healthaffairs.org/do/10.1377/hblog20170320.059267/full/

 

[JohnAdams]

What do you base this on? What I am reading in their statement is that they will be transparent with shifts in hearing thresholds. The purpose is to prove that it is safe and that there is no loss of hearing.

I expect them to show any shifts in hearing, even improvements. An improvement is an even stronger indication that the drug is safe for hearing. Right?

I probably should have ended that statement with a question mark.
I hope you're right and I hope it kicks ass.

 

[JohnAdams]

Allow me to break down how completely and tragically screwed up this article is.

then the $300,000 per year cost of providing patients the drug is a terrible waste of our health care dollars.

First off, it's not a WASTE to try to help suffering children, even if efforts fail. FFS these are suffering children. I guess the fucked up war on terror which adds zero safety to the world whatsoever and is all predicated on a lie is worth $2.1 million per US soldier! Forget suffering children.

https://www.yahoo.com/news/it-costs...ghanistan--report-133150602.html?guccounter=1

17 of the 19 hijackers on 911 were from Saudi Arabia anyway AND certain rich Saudis and Pakistani ISI agents bankrolled the attack. The Taliban had nothing to do with 911, which was the basis of the entire war!

However, if insurers do not pay for the drug and it actually would provide significant therapeutic benefit to Duchenne's patients, then there would be even more terrible unnecessary suffering and death among DMD patients.

How the hell does the existence of a working treatment, regardless of how it's paid for, cause MORE death? That's a twisted and ridiculously irrational statement.

Besides that drug has been clinically shown to be safe in several trials.

"Clinical safety data shows that there has been no adverse effects from treatment with Eteplirsen-based off the doses administered in several trials."

https://en.wikipedia.org/wiki/Eteplirsen

Eteplirsen is not by any means the only drug approved before the real risks were known or, in some cases, a lack of real efficacy was demonstrated.

That's some real word smithery bullcrap.
If the drug actually works, and it does, then how do you demonstrate a LACK of efficacy before it's approved? That's saying they didn't get a chance to see it not work before it was approved. Doip!!

American Cancer Society and the American Heart Association, focused their efforts on raising money for research and paid virtually no attention to the FDA.

Aw boo hoo we can't do anything in this world with the government!

Nothing in that article makes the case that fast tracking is a bad thing whatsoever. It just basically says a bunch of stuff and I guess the author hopes the readers think there is anything about this causing an issue because the title implies this.

Besides, you're not even an America and I am and I am totally fine with my government paying hundreds of thousands of dollars to help suffering child. We pay more than that to blow up children overseas!!!!

Seriously Ed. What is your infatuation with the FDA? Trials. I've posted quotes from Congress, the President and a Nobel Prize winning economist that all state that the FDA has too many pointless regulations. But you always swoop in with big ass nothing burgers to criticize criticism of the FDA. Seriously, are you their PR agent?

 

[Ed209]

You're completely missing the point, @JohnAdams. Read the links within the article as well.

No one is saying we shouldn't be treating sick children? Is that what you took away from the article? It's saying that a big safety risk is taken at the expense of getting the drug out into the market more quickly. And in the case of Eteplirsen, it was released before it was even proven to be efficacious. FX-322 shouldn't realistically have that problem as long as it shows repeated measurable improvements beyond a certain margin. Maybe 15 dB-20 dB and above at multiple frequencies.

I'll post one of the links from the article below which gives relevant information:

U.S. pharmaceutical regulations are based on the principle that patients should not be exposed to new prescription drugs until their efficacy and safety have been shown. Since 1962, the Food and Drug Administration (FDA) and Congress have balanced the efficient review of investigational drugs with the need to withhold judgment until sufficient evidence is available to clarify the benefit–risk relationship. Misjudging these competing interests in either direction causes important problems. On the one hand, the evidentiary hurdles of the FDA are often criticized by pharmaceutical companies and patient advocacy groups for slowing access to promising therapies. On the other hand, truncated premarket review can lead to the approval of drugs that are ineffective, unsafe, or both.

These dangers were once again made clear in October 2013 when approval was briefly suspended for ponatinib, a medication to treat leukemia that had been approved just the year before on an accelerated basis. Emerging data showed that 24% of the patients who had been followed for a median of 1.3 years and 48% of those who had been followed for a median of 2.7 years had serious thromboembolic events, including myocardial infarction and stroke.1 The drug was allowed back on the market in December 2013 with more limited indications and a restricted distribution system.

The latest development in the FDA approach to ensuring the safety and effectiveness of marketed prescription drugs occurred in July 2012, when Congress created a new category of "breakthrough therapy" in the FDA Safety and Innovation Act (FDASIA). A breakthrough therapy was defined as a new product to treat a serious disease for which preliminary clinical evidence suggested substantial superiority over existing options on one or more clinically significant end points.2 Lawmakers intended the designation to speed to market a limited number of products that showed "exceptional results for patients."3 Lauded by policymakers,4 consumer advocates,5,6 and the FDA itself,7 the breakthrough-drug pathway has been embraced by industry8 and has produced early results far exceeding predictions. From October 2012 through September 2013, the FDA received 92 applications for the breakthrough-therapy designation, of which 27 were approved and 41 denied (24 applications were still pending).9Although some of these agents may end up being truly transformative for patient care, the breakthrough-therapy designation also raises the possibility of a surge in new drugs that have been approved on the basis of limited clinical data.

There is ongoing controversy over the FDA standards for the approval of investigational drugs. In this article, we briefly summarize prior government efforts to expedite the availability of new therapeutics, and we discuss the clinical, ethical, and regulatory implications of the breakthrough-therapy designation.​

John, what many of us are trying to say is that it's not an easy process to go through. I couldn't care less about the FDA if I'm being honest, but you have to be realistic and look at the facts.

There are many variables you are overlooking:

• Do Frequency Therapeutics want to fast-track FX-322?

• What if it's released early and it's found, later on, to cause serious problems in the body.

• Hearing loss is not considered life-threatening, although it is an area that needs a treatment. AM-101 received fast-track status so maybe this will. However, it will still likely take years.

• What if the data isn't overwhelming and we enter a grey area?

There's lots to consider, but remember that I want this to succeed; I'm pretty sure we all do, why wouldn't we? We'd have to be crazy not to. It's early days though.

I just think you seem overly obsessed with it when we still have no idea what it will do for tinnitus.

 

[JohnAdams]

• Do Frequency Therapeutics want to fast-track FX-322?

Yes, David Lucchino said that in the latest interview with Bloomberg.

You don't even research or pay attention do you?

 

[Ed209]

Yes, David Lucchino said that in the latest interview with Bloomberg.

You don't even research or pay attention do you?

In that case then, let them get on with it. I don't think an intervention by any associations is necessary unless they face resistance and the data is overwhelmingly good.

 

[Ed209]

By the way, @JohnAdams, I just listened to the Bloomberg podcast and it was a cool interview with David Lucchino. It seems to me that they are on track and he said the results will be announced early next year. He also clearly said they will try and fast-track it, so I don't see any immediate problems for you to fret about.

Like we've been saying, he said wait until the next phase so they can further prove the concept.

 

[grate_biff]

I just think you seem overly obsessed with it when we still have no idea what it will do for tinnitus.

Must have something to do with every second of life being a living Hell and the fact that regeneration of hair cells is unprecedented through history. It doesn´t get much bigger than this.

Now, if it will alleviate or stop NIHL/SNHL induced tinnitus and hyperacusis we can still only make educated guesses.
In my opinion, it will. To me, it´s all about filling the "gaps".

We can talk about how complex this affliction is, and it is, because it involves our brain. And nothing is more complex than that, right?

Still the root cause, for most of us, is the ears' capability to transmit signals to the brain and the brain reacts to this in an effort to seek balance. In all neurological ways, the brain seeks balance.

So, why does someone develop tinnitus and some not?

Maybe I´m narrow-sighted and put too much of emphasis on my own case here, but I think it is a matter of "gaps" in our hearing. I am fortunate enough to show my upper end audiogram (8-16 kHz) and it really explains this "theory" in red and blue.



As you all probably know, red is right ear, blue is left.
As you can see, I have slightly more severe hearing loss in my right ear.
But do I have tinnitus in that ear? NO! Only my right ear, or on the right side of my brain, if you will.

The stern decline in my hearing "gap" (of 25 dB) must be the culprit then. It´s right there for all to see.

Also my tinnitus is matched to 12.5 kHz, right at the bottom of my decline in hearing of that ear. The loss of hearing on my left ear is more even, and the brain don´t feel the need to balance it out.

The reason for this btw is that I had a massive ball of wax in my left ear when I had my trauma, using headphones.

My hope, and belief is that Frequency Therapeutics drug can smooth this this out as FX-322 would know where it "hurts" and that my brain, probably as slow a process as it developed, will alleviate my tinnitus or even shut it the hell up... That's in line with what I know about brain plasticity.

Anybody find this interesting at all?
It certainly would be interesting to compare with others' "upper end" audiograms as I believe the evidence often lies there.

Sadly, very few has one.

 

[Johan_L]

I probably should have ended that statement with a question mark.
I hope you're right and I hope it kicks ass.

Reasons to provide full transparency on efficacy (if it works):

• It shows that it's safe
• Makes it easier to get patients to 2nd trial
• Showing that it works should scare off competitors from investing (as @Enclave was reasoning)
• Ego (They have put their life into this. I would want to be in the spotlight receiving fame and glory)
• Increase chance of Fast Track, and thereby making their $$$ sooner
• If they want investment capital

Reasons not to provide transparency on efficacy:

• It somehow helps the competition
• Legal reasons
• ...?

I am just reasoning by myself... any other ideas people?

 

[Don Tinny]

Reasons to provide full transparency on efficacy (if it works):

• Showing that it works should scare off competitors from investing (as @Enclave was reasoning)

That is what makes me doubt. I notice that there is a lot of research in different parts of the world that are still years away from getting to phase 1. Do they not know about FX-322? Or do they think it will not work?

 

[85dB T]

If they know it works they have to be wondering how to go about changing the world. It will be double-edged sword. A cure is a miracle for those with hearing loss but destruction for those who treat it.

Reminds me of Blockbuster Video stores, many businesses, careers and stocks will become extinct like dinosaurs.

 

[jeff W]

There is sadly zero evidence of that, which is why there is no reason to get excited about this.......yet.

Cochlear implants and hearing aids often eliminate tinnitus. This is well known in the field.

 

[JohnAdams]

We are on the cusp of a new age.