Deathtotinni
Member
- Dec 21, 2017
- 157
- Tinnitus Since
- 9/10/17
- Cause of Tinnitus
- Qtip and maybe a sound..who knows
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Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
Member@Street Novelist Some member here told us that they will disclose their results in Januar next year. I just hope that this or even next month they will not prolong their disclosure by saying - we will have the results in March or something like that.
Deathtotinni
Member
- Dec 21, 2017
- 157
- Tinnitus Since
- 9/10/17
- Cause of Tinnitus
- Qtip and maybe a sound..who knows
Wow really good thinking which makes me think maybe they found success. Oddly I think I have some tinnitus in my left ear but I haven't been exposed to any sound recently. I have it in my right but now I'm feeling it in the left but I really can't be sure. No hearing loss over there but who knows.
Coleoptere
Member
Maybe they discuss the results first with the FDA to go to break-through/fast track status and combine that with the setup for Phase IIb. But maybe I'm too optimistic and of course this is my speculation.
Chad Lawton
Member
- Mar 1, 2018
- 253
- Tinnitus Since
- 02/2018
- Cause of Tinnitus
- Possible Ototoxicity + Noise Exposure
I highly doubt they are going to provide the detailed information that everyone is hoping for.
If it is successful, I bet all it will be is "We successfully met our clinical endpoints for the trials and we did see a clinically significant improvement in patients hearing". Clinically significant can mean an improvement of 10 decibels.
If people are hoping for information on whether it helps tinnitus or not, they've got a long wait ahead.
I doubt they are going to provide numbers like how well everyone did on their audiograms, etc.
If it is successful, I bet all it will be is "We successfully met our clinical endpoints for the trials and we did see a clinically significant improvement in patients hearing". Clinically significant can mean an improvement of 10 decibels.
If people are hoping for information on whether it helps tinnitus or not, they've got a long wait ahead.
I doubt they are going to provide numbers like how well everyone did on their audiograms, etc.
The have a 90 day followup period, and the final participant was injected in early october. So trial should finish first week of January. Then they probably need 1 or 2 weeks to summarize things for the press release.
Which companies are at risk of being put out of business from FX-322?
I'm thinking the hearing aid companies? Who are the big players and how big a threat is a successful FX-322 to them?
I'm planning on observing their stock when FX-322 trial comes out... (does it drop?) and maybe do a long term short on their stocks. Thoughts from the business/finance people here?
I'm thinking the hearing aid companies? Who are the big players and how big a threat is a successful FX-322 to them?
I'm planning on observing their stock when FX-322 trial comes out... (does it drop?) and maybe do a long term short on their stocks. Thoughts from the business/finance people here?
It isn't actually certain whether FX-322 will initially be a direct threat to hearing aid companies.
It is the current belief that FX-322 will be most helpful towards those with mild/moderate hearing loss, which for a lot of people doesn't merit hearing aids.
In 2017 the President Trump in the United States signed into law new legislation called the Over-the-Counter Hearing Aid Act of 2017. This law allows for non-prescription, low cost devices that likely will pose a threat to hearing aid companies. So their risk may already be happening, even before biological innovations such as FX-322. I expect things like FX-322 would help make hearing aids go the way of the horse & buggy even faster, but right now the new law likely will impact the hearing aid companies, at least in the United States.
In October 2018, the FDA approved the first device under the new law, it is made by Bose. No need for a hearing aid company or an audiologist!
"The U.S. Food and Drug Administration today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider."
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622692.htm
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I think it's all bull. Spent plenty of money on doctors to see them leave in their white Mercedes with no solution. If doctors and biotech companies were only paid on results they would find an answer. I do personally believe restored hearing would help tinnitus, but until I hear the words tinnitus cure, I'm not holding stake on anyone. I'll check once a month and that's it. I'm hopeful for all to get relief through Frequency Therapeutics, Audion or whoever.
Your average Dr. practicing medicine in a clinic or hospital is just a product of the medical education system. They are taught the literature on symptoms and approved treatments. They don't have the time or resources to innovate and advance treatments that require heavy lifting like tinnitus and hearing loss. The problems we are talking about here are very complex and thus require dedicated researchers. Your expectations are sort of like expecting your average auto mechanic to design an all electric car that charges in <15 minutes and has a 300 mile range... 15 years ago.
The market has always been here, just look at hearing aid sales, but the issue has been coming up with a solution. In the mean time, continue to support both university, government and private sector research in these areas.
I doubt this will get much press either way. No one really seems to care about hearing loss and tinnitus. There are breakthrough articles all the time if we read the news, but they always have the disclaimer that it could lead to something. Didn't GenVec come out and say that their CGF166 helped some people... and nothing happened. I don't see anything that Frequency Therapeutics develops threatening them. We still don't know what the outcome will be of the trials. Is a 10 dB gain enough to warrant not getting a hearing aid? Maybe, maybe not. You are still risking money unless you know the outcome of the trial. The outcome would have to be really really good and even then they would need to have a clear path moving forward to getting it approved. Even then I'm not sure it would do much unless FX-322 takes you back to 100 percent. As mentioned this is targeted toward moderate/mild loss. If it could put profound people into the moderate range then they would be candidates for hearing aids, this could open up business for them as well. Either way, I don't think this is a stock play.
Depending on how many supporting cells are present, I don't think that the actual amount of hearing loss is relevant. If it can regenerate one cell then why not all of them? It may just take multiple treatments.
Deathtotinni
Member
- Dec 21, 2017
- 157
- Tinnitus Since
- 9/10/17
- Cause of Tinnitus
- Qtip and maybe a sound..who knows
They are going to provide the information and outcome of the trial lol. This information is very detailed. They provide answers to every single thing they measured in detail.
I honestly can't believe the negativity some of you have but I guess tinnitus will do that to someone.
I think you're right about them not telling every person audiogram but they will give the average improvement dB for their audios. You can go on clinicaltrials.gov and see what they are measuring.
Deathtotinni
Member
- Dec 21, 2017
- 157
- Tinnitus Since
- 9/10/17
- Cause of Tinnitus
- Qtip and maybe a sound..who knows
Bad news... I don't think we are going to get an answer to whether or not they improved in hearing.
https://clinicaltrials.gov/ct2/show/NCT03616223?cond=Hearing+Loss,+Sensorineural&draw=2&rank=3
Doesn't say they are measuring hearing improvement even though they are. Maybe they will say in the press release if they saw a hearing improvement.
https://clinicaltrials.gov/ct2/show/NCT03616223?cond=Hearing+Loss,+Sensorineural&draw=2&rank=3
Doesn't say they are measuring hearing improvement even though they are. Maybe they will say in the press release if they saw a hearing improvement.
I think if they fast track the drug and continue to the next stage, then we can pretty much conclude the results were positive.
That's what I've been saying.
That's why I was crying hysterically that we should be organizing and pushing the ATA and BTA and WWP to acknowledge this as being a much needed potential cure for tinnitus and all I got was flak from the perfectly habituated FDA warriors.
Deathtotinni
Member
- Dec 21, 2017
- 157
- Tinnitus Since
- 9/10/17
- Cause of Tinnitus
- Qtip and maybe a sound..who knows
- Oct 17, 2017
- 642
- Tinnitus Since
- 2005
- Cause of Tinnitus
- unknown - possibly hereditary
Not necessarily, 30% of pharmaceutical trials in phase 3 stage fail. FX-322 isn't yet in phase 3. It could fail. Don't put all your hopes on it.
So they're doing audiometry on their subjects. Assume no majorly bad effects. If there were, they would have shut down the trial. This is a safety trial only in theory. But even if the drug is safe and no-one's hearing improves, why would you bother with the next phase? So if there is a next phase, can we assume that someone's hearing improved?
It's a similar thing with the Regain Hearing Project trial. They're moving on from phase 1 to phase 2 in the new year. They've been doing phase 1- including audiometry- for a year. If no-one's hearing has improved in that time, why waste everyone's time? If at least one person's hearing has improved, why not crow about it? It would be the first person in human history to have a sensorineural hearing loss reversed.
I guess what I'm saying is that I don't really see the distinction between an efficacy trial and a safety trial in this case. Anyway, I'm looking forward to the results like everybody else.
It's a similar thing with the Regain Hearing Project trial. They're moving on from phase 1 to phase 2 in the new year. They've been doing phase 1- including audiometry- for a year. If no-one's hearing has improved in that time, why waste everyone's time? If at least one person's hearing has improved, why not crow about it? It would be the first person in human history to have a sensorineural hearing loss reversed.
I guess what I'm saying is that I don't really see the distinction between an efficacy trial and a safety trial in this case. Anyway, I'm looking forward to the results like everybody else.
Chad Lawton
Member
- Mar 1, 2018
- 253
- Tinnitus Since
- 02/2018
- Cause of Tinnitus
- Possible Ototoxicity + Noise Exposure
Exactly. While they are measuring hearing improvement via audiograms, they are only reportedly measuring adverse side effects and time of drug concentration in plasma. Those are the only 2 things that they have to report in order to call the trial a success. Doubtful we will see any numbers on hearing improvement. I'd be glad to be wrong.
Exactly. Why would they even plan another round of trials if they at least didn't see some improvement in this one?
I honestly don't see how it could fail. It restored hearing in mice, and the process worked in an explant human cochlea. It would be nice if someone could actually offer an argument as to how it could possible fail that they didn't find while dumpster diving at Taco Bell.
It may cause dysacusis however. Let's hope not.
Deathtotinni
Member
- Dec 21, 2017
- 157
- Tinnitus Since
- 9/10/17
- Cause of Tinnitus
- Qtip and maybe a sound..who knows
Jeezus another naysayer.
My hopes are up because it's been tested on the human ear outside of the body, mice, and a primate. I'm a primate.
The odds are still greater because it isn't like traditional drugs. We don't know any of the side effects, if there are any yet. I doubt anything terrible would happen because of the other clinical trial that allowed some people to regain hearing. That trial has been going on for years, I think it's generally safe and efficient.
- Jul 2, 2015
- 111
- 49
- Tinnitus Since
- 6/26/2015
- Cause of Tinnitus
- Idiopathic + Sudden hearing loss
Not true at all. Hyperacusis is in increase in auditory gain. If the sound levels you are exposed to are bothersome you reduce them by avoiding or protecting your ears - always. Your ENT misspoke or does not know what he's talking about. Hyperacusis usually slowly subsides as you become acclimated to the new normal hearing ability. Protect your ears from any sound level that bothers you.
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