I hope they allow expanded access during Phase 2a or after. The waiting is killing me.It's up to Frequency to allow expanded access. Unfortunately, they said they are not ready to do so at this time.
I hope they allow expanded access during Phase 2a or after. The waiting is killing me.It's up to Frequency to allow expanded access. Unfortunately, they said they are not ready to do so at this time.
When do you think they will feel ready for the expanded access?It's up to Frequency to allow expanded access. Unfortunately, they said they are not ready to do so at this time.
Yes, I'm well aware of it and their policy has been shared as well:It's up to Frequency to allow expanded access. Unfortunately, they said they are not ready to do so at this time.
Frequency has to consent to sell & also manufacture the drug.Is there no way to legally demand "expanded access" use under the Right to Try act?
Space X found a way to get around the handful of people wasting time and money at NASA. Looks to me FDA has the same type of people, a small group of spoon fed people calling all the shots.I agree 1000%. We could potentially all have had restored hearing by now if not for the behemoth time & resources that go into getting drugs approved.
However it's hard for me to imagine a 'Space X' approach to the FDA. Any actual ideas on what this would look like?
It's very illegal for two consenting parties to have a drug transaction unless the FDA approves it. Personally I think the FDA should be looked at as a guideline, not a draconian-style lockdown on what adults can & can't do...
My guess is early to mid 2022. I think they will open up expanded access after Phase 2a if the desired efficacy and safety profiles are shown. However, I think we will then need to wait until recruitment for Phase 2b or 3 is complete as @FGG highlighted. Otherwise, there would be no incentive to risk getting a placebo during the trial if you could just receive expanded access. Being that this will be the "pivotal" phase prior to submission for approval, it will certainly take some time to recruit such a large trial population. Therefore, I feel our best chance to try FX-322 is early to mid 2022.When do you think they will feel ready for the expanded access?
I dearly hope all of you are wrong! But all what you are saying is making too much sense, damn it.My guess is early to mid 2022. I think they will open up expanded access after Phase 2a if the desired efficacy and safety profiles are shown. However, I think we will then need to wait until recruitment for Phase 2b or 3 is complete as @FGG highlighted. Otherwise, there would be no incentive to risk getting a placebo during the trial if you could just receive expanded access. Being that this will be the "pivotal" phase prior to submission for approval, it will certainly take some time to recruit such a large trial population. Therefore, I feel our best chance to try FX-322 is early to mid 2022.
There's already a trademark for that by an earplug company.I vote Eargasm
What's the point of speculating? It's not going to be exorbitantly expensive, otherwise not many are going to be able to afford it and they want normal people to be able to afford it. I'm sure the treatment costs less than $5,000.In all seriousness, how much would a treatment per ear cost?
Then when they reformulate to reach all frequencies: "ultimate eargasm".On a lighter note, what do you think FX-322's name will be? I vote Eargasm.
In all seriousness, how much would a treatment per ear cost?
I'm a huge Elon Musk fan, and I also believe 3 things are necessary for quality:Space X found a way to get around the handful of people wasting time and money at NASA. Looks to me FDA has the same type of people, a small group of spoon fed people calling all the shots.
One idea is go to a university and collect a very smart crew to do an IRB and do a PMA but without the FDA submission. Do your own studies as you do anyway. Then you evaluate yourself or even better pay a bunch of independent PhDs to evaluate for you. Once a high level of agreement is achieved with these highly-educated doctors then you're good, start injecting all these suffering people.
The amount of time will be less to complete. Cost for the studies will be about the same. You indicate the risks in evaluations just as you would do for the FDA but you don't submit. Then you state when you sell the product that it has not been submitted to the FDA but we did evaluations with top university graduates from school(s) that follow a strict protocol. You indicate the side effects, go deaf, death, etc... that could occur the same way and you sell from your clinical evaluation.
Anybody who is educated can view the studies and take part in the risk to try.
If someone dies while taking a FDA approved drug guess whose fault it is? The FDA directs the business that created it! That's why the FDA is careful with wordings. When they approve a drug, they never say it's approved. It's simply 'cleared for use' so they release liability. What that means the FDA won't bother you when you are cleared for use. They never say they 'approve' you. They use the word cleared for use. It's a law thing. The FDA is a spoon fed entity of overrated ****.
Again, Elon Musk, Space X. He reduced those NASA peer review people and look how much more gets done compared to NASA. We're back in space again!
The proof is there. The FDA is an obstruction. But I do believe you need to have a regulatory type of system. I don't believe there should be one entity to control it like the FDA. The FDA is a type of monopoly that needs to be changed.
Another huge problem I have with the FDA is they created an environment where the bogus companies dupe investors to invest in their bogus treatments that take 10 years of FDA nonsense to finally bring the scam to light. It's a scam going on that gives us false hope and we put up with it all for who knows what reason.
If I've upset anyone with what I have written it was not my intention. I wish for all of us to end this suffering. I know there's a better way. Maybe I have it figured out, maybe I don't. Please, protect your ears.
We shouldn't force anyone to sell anything, that wouldn't be ethical.Yes, I'm well aware of it and their policy has been shared as well:
https://www.frequencytx.com/expanded-access-policy/
Right-to-try laws are U.S. state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA).
But this only works if the pharma company in question works along with it. Is there no legal way to force a company to share its drug via compassionate use/expanded access? Otherwise this act is so useless. Because you can't push for your right to try, it's up to the pharma. Right to wait act. I'm just flaming over here, with probably zero success rate.
Only thing that might raise the price is that you don't need to keep using it to keep your hair cells. It's four injections. Maybe more with severe hearing loss, but ultimately you're probably done within 4-8 weeks.There's already a trademark for that by an earplug company.
What's the point of speculating? It's not going to be exorbitantly expensive, otherwise not many are going to be able to afford it and they want normal people to be able to afford it. I'm sure the treatment costs less than $5,000.
Cochleum HF - $1000 per single injection (HF for High-Frequency).On a lighter note, what do you think FX-322's name will be? I vote Eargasm.
In all seriousness, how much would a treatment per ear cost?
Not exactly. Just because the hair cells are replaced doesn't make them invincible. They'll keep wearing like everyone else. So, there will be people that will someday come back for a second round from new damage/wear; it is inevitable.Only thing that might raise the price is that you don't need to keep using it to keep your hair cells. It's four injections. Maybe more with severe hearing loss, but ultimately you're probably done within 4-8 weeks.
Yeah I can see this being the case, but that's still better than no one being able to get their issues fixed...Not exactly. Just because the hair cells are replaced doesn't make them invincible. They'll keep wearing like everyone else. So, there will be people that will someday come back for a second round from new damage/wear; it is inevitable.
This treatment will create a whole new class of people who don't change their perspective, unfortunately. Where they come in to the ENT with issues like we have, but get it fixed right away, and go back to abusing their hearing again because the lesson wasn't sustained.
Would the reformulation be Cochleum AF (AF for All-Frequencies)? It's also the common abbreviation for "As Fuck", lol.Cochleum HF - $1000 per single injection (HF for High-Frequency).
Sure, but I mean it's not the same as insulin or anti-psychotic drugs.Not exactly. Just because the hair cells are replaced doesn't make them invincible. They'll keep wearing like everyone else. So, there will be people that will someday come back for a second round from new damage/wear; it is inevitable.
This treatment will create a whole new class of people who don't change their perspective, unfortunately. Where they come in to the ENT with issues like we have, but get it fixed right away, and go back to abusing their hearing again because the lesson wasn't sustained.
Their first presentation had the drug in 20000-3500 Hz.In the June presentation I see they enlarge slightly the area of potential restoring from 8000-20000 Hz (back in January or so) to 6500-20000 Hz (p15 in this presentation). So maybe the 4 doses are actually having an enhanced effect.
I saw some opinions here that they hope to address frequencies from 3500 upwards, but I didn't see any source.
Anyone has a better idea on the range they hope to heal? And from what losses onward in dB ranges? Mid/severe don't speak to me a lot in terms of actual numbers.
In terms of timeline, I think 2023 is still a bit optimistic to reach mass production and distribution. Plus they will have to advocate this a lot to the doctors so that patients can actually get it. But it's a good breakthrough!!! Keep the faith people!
20,000Hz , so are we going to hear like a baby?Their first presentation had the drug in 20000-3500 Hz.
Mild hearing loss = 20/25-40 dB PTA
Moderate = 40-55 dB
Moderately severe = 55-70 dB
Severe = 70-90 dB
Profound = 90 dB and upwards
PTA = pure tone average
Probably our ears are not that of a newborn after treatment. But as far as I understood it inner and outer hair cells are regenerated in the high frequencies. So in theory this should quieten high frequency tinnitus. Hopefully they are working to reach all frequencies. But if tinnitus is due to some nerve IHC connection problem, FX-322 won't help since the hair cell is still alive. There are some drugs in development that address this problem OTO-413, Hough Pill, Pipeline, but I am wondering whether it is also possible to take some targeted ototoxic drug, which just brings these disconnected but still alive IHCs over the edge.20,000Hz , so are we going to hear like a baby?
Sounds extreme - I think OTO-413 or the Hough pill will become available before any drug that deliberately "finishes" off hair cells.Probably our ears are not that of a newborn after treatment. But as far as I understood it inner and outer hair cells are regenerated in the high frequencies. So in theory this should quieten high frequency tinnitus. Hopefully they are working to reach all frequencies. But if tinnitus is due to some nerve IHC connection problem, FX-322 won't help since the hair cell is still alive. There are some drugs in development that address this problem OTO-413, Hough Pill, Pipeline, but I am wondering whether it is also possible to take some targeted ototoxic drug, which just brings these disconnected but still alive IHCs over the edge.
You normally lose the high frequencies first, which is why tinnitus is usually high pitched.Long time lurker here. This is the first I've checked this thread in about a year, but I must say 6500 Hz-20000 Hz seems pretty disappointing to me. I tested that range with various audio files on my computer with high-end speakers and I guess I'm not seeing how improving that range is really going to help much. I mean, anything is better than nothing, however, when you have to pay thousands or tens of thousands for it, I'm not sure it will be worth it.
Have they ever released any data on how many decibels recovered in the test subjects? If it's only a couple, I just don't see how this will make much of a difference. If it's substantial, I'd also worry about everything potentially sounding too high-fi in comparison to other frequencies, making everything sound like it's coming from an iPhone speaker.
Any data thus far is only on a single small safety test dose. There should be very different results reported at the end of the current trial. No one has those results yet but they used a higher dose given 4 times instead of a single injection.Long time lurker here. This is the first I've checked this thread in about a year, but I must say 6500 Hz-20000 Hz seems pretty disappointing to me. I tested that range with various audio files on my computer with high-end speakers and I guess I'm not seeing how improving that range is really going to help much. I mean, anything is better than nothing, however, when you have to pay thousands or tens of thousands for it, I'm not sure it will be worth it.
Have they ever released any data on how many decibels recovered in the test subjects? If it's only a couple, I just don't see how this will make much of a difference. If it's substantial, I'd also worry about everything potentially sounding too high-fi in comparison to other frequencies, making everything sound like it's coming from an iPhone speaker.