Member- Mar 22, 2018
- 90
- Tinnitus Since
- 08/2017
- Cause of Tinnitus
- Hearing loss (stress + virus activation)
Do you know if there is a limit too like 80 dB @ 4 kHz being too much loss? Thanks.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
Do you know if there is a limit too like 80 dB @ 4 kHz being too much loss? Thanks.
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
Exactly! As much as they say and want this to be strictly a safety trial, it isn´t. Regeneration of hearing will of course be measured. What they mean is that they will keep this result to themselves. So fingers crossed it will move to phase ll.
This is a combined phase 1 and 2. The next phase very well may be phase 2/3 or phase 3. I don't get why it has to take so long though.
This trial is simply a risk reduction trial from a business standpoint. Call it whatever you want for the FDA, but there are unofficial trial endpoints that will drive whether or not Frequency moves ahead on this in future trials.
No limit on 80 dB, you can still apply and be part of the study.
Exclusion Criteria:
- Persistent perforation of tympanic membrane or other tympanic membrane disorder that would interfere with the delivery and safety assessment of an intra -tympanic medication or reasonably be suspected to affect tympanic membrane healing after injection.
- Any conductive component defined as air-bone gaps >10 dB at two or more frequencies.
- Auto Immune Disease
Let's hope, that restoring hearing will eliminate tinnitus. May God let this happen.
They still need participants...
Rings-a-Bell
Member
Call them.Is there a location requirement? I am outside the US but can fly in perhaps
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
I strongly believe it will as I´m a firm believer of the "phantom noise" theory. Also think it will help hyperacusis, as I believe it´s a direct result of tinnitus (but I can only speak from my own experience).
Or the combination of the very sharp brains at Frequency Therapeutics and mother nature!
I´ve already contacted them twice. As the ENT said: thousands of requests received! My guess is geography plays a big role here, due to costs and practicality.
I think they are full of crap and are nowhere even close to anything to help anyone.
I think it's a show to get money at the expense of people suffering every second.
Yes I know I'm mad, but I'm so out of HOPE. My brain is screaming like a skill saw ripping through glass
sorry
Rick
I think it's a show to get money at the expense of people suffering every second.
Yes I know I'm mad, but I'm so out of HOPE. My brain is screaming like a skill saw ripping through glass
sorryRick
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
I have to say, as much as I love and admire what Frequency Therapeutics are doing and hopefully are going to achieve, I´m dying to know why things are moving so incredibly slow. At least if phase I/II are successful and safety is confirmed, I expect them to fast forward to the next phase.
I´ll bet researching is fun, and not something to take lightly, but we desperately need an end-product over here!
I´ll bet researching is fun, and not something to take lightly, but we desperately need an end-product over here!
- May 7, 2015
- 1,045
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
It says under my avatar (Location
). And when on the subject, I think everyone should show where they are from, why hide this? I see you do! Why?
- Mar 22, 2018
- 90
- Tinnitus Since
- 08/2017
- Cause of Tinnitus
- Hearing loss (stress + virus activation)
If it works and that goes public they can sell tickets for phase II. I would camp outside their office! I even would bring the needles at my own cost!!
Thanks for looking up the criteria for me.
I think that this phase is too early for me to try as the traveling costs and time is for me impossible right now. I was just afraid the profound hearing loss may exclude me from the trial already in that early stage and I have a gap that's 30 dB+ so maybe that's also not that great for their study.
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- Mar 22, 2018
- 90
- Tinnitus Since
- 08/2017
- Cause of Tinnitus
- Hearing loss (stress + virus activation)
You think it's just another Kickstarter campaign with no product? Just really nice made explainer videos? A crypto MedCoin? or a TinniCoin?
Yeah who knows... but let's try to stay positive... let's hope!
I'm mad at the whole system but I don't think they are just scamming people. They really want this to work. Then they're rich.I think they are full of crap and are nowhere even close to anything to help anyone.
I think it's a show to get money at the expense of people suffering every second.
Yes I know I'm mad, but I'm so out of HOPE. My brain is screaming like a skill saw ripping through glass
Rick
Nah. If it doesn't work they won't make money. So they definitely think it might work else they wouldn't continue their investment.
I hope it works and that it goes public sooner than what we can expect.
I will try to contact the ENT in a couple of months to check on the results and/or if they let me in for phase 2. Will see.
Either way I will also camp outside early bird.
I totally agree, I just hope that by restoring hearing it will also cure tinnitus and hyperacusis.
- Mar 22, 2018
- 90
- Tinnitus Since
- 08/2017
- Cause of Tinnitus
- Hearing loss (stress + virus activation)
Rubenslash
Member
Slow? This is really how clinical testing works. This trial is advancing in line with the expected timetable.
If it doesn't work wouldn't they drag it out as long as possible until the grant money runs dry? (assuming grant money. I don't know, just speculating)
Well maybe but they'd get in huge trouble if they got caught doing anything like that. Also, and more critically, they surely have to show that the grant money was used for research, so there remains no incentive to spend it if the project is failing.
But of course yeah, it's not foolproof.
I think I know exactly why they arent reporting efficacy this round with fx322,
especially regarding tinnitus.
Money/time.
Even if they are getting reports of tinnitus getting better, they cant just come out and claim that yet unless part of their study specifically was testing for that under FDA controls. That's more metrics, more testing, more time. Safety is the prime thing to get it going into phase 2, 2/3. You bet your asses they are keeping private data on hearing recovery and tinnitus, they just cant claim that publicly yet. To make a medical claim it has to be approved by the FDA.
especially regarding tinnitus.
Money/time.
Even if they are getting reports of tinnitus getting better, they cant just come out and claim that yet unless part of their study specifically was testing for that under FDA controls. That's more metrics, more testing, more time. Safety is the prime thing to get it going into phase 2, 2/3. You bet your asses they are keeping private data on hearing recovery and tinnitus, they just cant claim that publicly yet. To make a medical claim it has to be approved by the FDA.
Haven't they received funding from the government (Department of Defense)? I don't think the government would invest (I know it is a small sum) in something they thought was flimsy. But what do I know...
The DoD gave them frigging chump change. 2 million. They need to ante the f##< up and give them 100 million. They have to spend all their money funding jihadis in Syria I guess. Soldiers get tinnitus all the time.
- Mar 22, 2018
- 90
- Tinnitus Since
- 08/2017
- Cause of Tinnitus
- Hearing loss (stress + virus activation)
It's the purpose of startups to get investments, it doesn't matter where they get the money from.
What they sell is an idea, nothing else, and include that idea into some marketing and then sell a % of the company.
Of course you also need some people at the front with reputation to act serious on the market. I wouldn't sell a lot of the company at that stage. I would wait for phase 1.5 and then they would know more if they want to take the risk or sell more of the company.
They rated their company at an early stage combined with their idea and the investor bought some % of the company or some % of sales etc. whatever. What they do now with the money is the decision of the company. I don't think you can blame someone at Frequency Therapeutics for what they do with the money they got... that's the deal. It's like betting on something for the investor. They don't have to pay money back if it just doesn't work out. They close the company and open a new one.
I am too new to these health findings and I don't know if the investor is a famous/well known Investor in that business and if the investment is high? Depends on the % they got. Don't know where I can look that up for American companies? What companies did the investor also invest ion? Did they work out? Is it a good partner for Frequency Therapeutics...?
They will of course try to make more money out of the investment so of course they hope the drug will work but it would be silly to believe that they don't pay themselves a good salary etc. the investment is nothing else than money based on a business plan that also includes salaries of course, cars to drive from A to B etc. An investment is opening a time window for the idea to get to the market or to reach new goals/milestones to get again new investments. I mean when they reach a milestone with phase 1.5 they have a very early possibility to get new investors for the final punch.
I don't know where to look up who holds n-percentage of the company. Sometimes an investor also selling his % could be a sign of too high risk that it may fail etc based on insider knowledge. Let's see what's happening after that 1.5 phase.
The investment of the DoD is not high. I have two friends who have startups in the ehealth sector which is of course different but two millions of a government....the US...thats really not much but I think they wait for a market release its positive anyway that they invest that means it could work at least and the approach seems stable in the theory.
Well these are only my thoughts about that....
What they sell is an idea, nothing else, and include that idea into some marketing and then sell a % of the company.
Of course you also need some people at the front with reputation to act serious on the market. I wouldn't sell a lot of the company at that stage. I would wait for phase 1.5 and then they would know more if they want to take the risk or sell more of the company.
They rated their company at an early stage combined with their idea and the investor bought some % of the company or some % of sales etc. whatever. What they do now with the money is the decision of the company. I don't think you can blame someone at Frequency Therapeutics for what they do with the money they got... that's the deal. It's like betting on something for the investor. They don't have to pay money back if it just doesn't work out. They close the company and open a new one.
I am too new to these health findings and I don't know if the investor is a famous/well known Investor in that business and if the investment is high? Depends on the % they got. Don't know where I can look that up for American companies? What companies did the investor also invest ion? Did they work out? Is it a good partner for Frequency Therapeutics...?
They will of course try to make more money out of the investment so of course they hope the drug will work but it would be silly to believe that they don't pay themselves a good salary etc. the investment is nothing else than money based on a business plan that also includes salaries of course, cars to drive from A to B etc. An investment is opening a time window for the idea to get to the market or to reach new goals/milestones to get again new investments. I mean when they reach a milestone with phase 1.5 they have a very early possibility to get new investors for the final punch.
I don't know where to look up who holds n-percentage of the company. Sometimes an investor also selling his % could be a sign of too high risk that it may fail etc based on insider knowledge. Let's see what's happening after that 1.5 phase.
The investment of the DoD is not high. I have two friends who have startups in the ehealth sector which is of course different but two millions of a government....the US...thats really not much but I think they wait for a market release its positive anyway that they invest that means it could work at least and the approach seems stable in the theory.
Well these are only my thoughts about that....
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