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Yeah this is what I mean. We should be focusing on initial approval regardless of whether the current combo reaches all the frequencies we want. They will end up reformulating either way because the technology exists and multiple shots per ear is damn inconvenient for everyone. At that point...

@FGG I think I remember talking to you several months ago about how it would take a year of trials to approve a reformulation of an FDA approved drug. The context being that the delivery vehicle to treat the entire cochlea exists (I think pipeline is using it?), but this technology is not used...

I hope Woodcock takes it then! Less regulation is better in my book.

Considering that it was Trump who opened up Compassionate Use, I doubt Biden's new FDA head will be willing to break down bloated FDA regulations. It was also Trump's head of the FDA that said last year that regulation reform is needed. Of course haven't seen any action taken to backup that...

I don't think it's very likely. Someone on Reddit talked once about how he'd had over 30 or so ear injections and was fine afterwards. I mean some people have gone blind from LASIK; any procedure has a small amount of risk. Personally I would take the first of 4 injections of FX-322 in each ear...

While I agree with this chain of thinking and have posted as much before, I think it takes a certain amount of cynicism to believe that Frequency isn't genuinely looking at Expanded Access after Carl LeBel just said on the Tinnitus Talk Podcast that it was something that they are "certainly...

Done: FDA Rage Thread Feel free to make a post there ha.

Hey all, I and others have grievances with the FDA. In an effort to keep other threads from going being derailed, I have created this thread as a safe place to: 1.) Criticize the FDA 2.) Propose better solutions I'll follow up with a post explaining my personal points of concern below.

Carl LeBel on Expanded Use during the Tinnitus Talk Podcast: "[...]firstly and importantly our position on expanded access is due to really the fact that we don’t fully feel that we’ve been able to characterise the safety profile of the drug yet. And so loosening the philosophy of sharing...

Something that I haven't seen mentioned here (but I may have missed it) from the Tinnitus Talk Podcast is that LeBel more or less confirmed that Expanded Access is going to depend on phase 2A results. To me this is great news. All we knew before was from Frequency's website, which stated they...

@MrCrybaby I remember you saying you had similar fullness/popping symptoms to me and attributed it to middle ear muscles spasming. You expressed that you think FX-322 might remedy this. I was wondering if you could provide any additional insights - mine constantly pop when I swallow or move my...

Yeah, I think you and I have really different values here. As long as a company isn't selling straight up poison and calling it medicine, I don't see what the problem is. You mention "druggies" exploiting legal drugs for recreational use. So the people these drugs can help shouldn't get to use...

This is interesting, I thought damaged cells almost always enter apoptosis. I'd say maybe they were referring to synapse damage, but that's not what this drug is for...

Are you familiar with what it takes to get a drug after a sponsor allows for expanded access? There's a lengthy paperwork process involved for each individual. For something like FX-322, this means Frequency would have to devote a lot of resources to this "red tape" alone. If new legislation...

There's actually legislation that says the FDA can't take what happens with Right To Try cases into consideration when considering a drug for approval - only the cases in actual clinical trials. Also one of the requirements for compassionate use is that you don't qualify for a trial. I suppose...

This is why Right To Try isn't enough. We need provisional approval to let drugs actually hit the market earlier as opposed to a process that's riddled with red tape. I do think this will happen via legislation and the FDA will also improve via reform, but probably not until at least a few...

I hope so, for my sake and other's. The thing is the technology exists to regenerate inner/outer hair cells, and also to regenerate synapses. It exists right now. It's just a matter of waiting years for the FDA to either. - Approve the drugs - Go through reform so that drugs can be approved...

Hey, I just saw this! Didn't get a notification for some reason. I intended to come back around when @GlennS originally brought this up but never did. I'll do a write up when I'm back at my computer.

- They are giving 1, 2, and 4 doses to different test groups - The dose is the drug & the delivery vehicle (this is a gel) - Concentration is the same. Changing the concentration or delivery vehicle requires an additional FDA trial that takes a year before it is legally allowed to hit the...

Yeah both of mine feel full and pop/crack when I fully extend my jaw or swallow. I also get mild ear pain maybe once a day, for a few seconds. I guess that would make sense if the inner ear muscles are spasming and being overworked. Has to be related to hearing loss... I'm kind of scared that...

Yep, I did have an acoustic trauma about a month before all my symptoms showed up. Feeling a lot better now that I know I should be able to get this fixed within the next year or two. Don't know what I'd do without you guys... probably tons more time spent worrying and researching instead of...

Maybe it isn't ETD as per @MrCrybaby. I assumed it was ETD after doing some research on my symptoms, but he nailed what my symptoms are and it makes more sense, given when they arose.

Those are exactly my symptoms. Thanks so much! Sometimes I can get the fullness to go away after popping them, but normally only for a few seconds, and a few minutes at the most. I've never had these issues before, it's just too much of a coincidence to not be related. Just one more reason to...

I've had pretty much the same thing happen. For me the solution is pretty much always rain sounds, cricket sounds, or other similar sounds. Tinnitus sucks but honestly I'm glad I discovered these ambient noises. Some of them really breathe life into an environment and I find them stimulating...

Do you guys think that hearing restoration could also curb or possibly erase ETD symptoms? Mine started shortly after my tinnitus did, and at times it's more annoying than the tinnitus itself. I'm not very well versed on what causes ETD but I can't help but think it's related to hearing loss...

Agreed. Also, it might not be very useful as far as FX-322 goes, but it seems like it could help us access things like the Hough Pill or OTO-413 faster. As I understand it, if you have noise-induced hearing loss, you likely not only have inner/outer hair cell loss, but synapse damage as well.

Really exciting. This is what we need to see more of.

3 years of profits is a massive amount of money, I doubt they'd leave that on the table. Frequency does have competition, there are other biotech labs that aren't far behind. Even things like hearing aids (we use these to speculate on what the cost of FX-322 will be) and upcoming synaptopathy...

Individuals in the FDA probably are interested in getting it approved. I'm just saying there's a big difference between - A biotech (Frequency) that has to work to survive, has competition, has accountability to shareholders, and a vested interest in FX-322. - A government agency (FDA) that...

So I think there's 3 things going on here. 1.) COVID-19 has slowed things down in general 2.) Frequency is looking for a very specific level of hearing loss where FX-322 will shine 3.) The older you are, the more likely you have hearing issues. Older people are more at risk with covid so this...

What do you all think about how FX-322 will be administered? Do you think they'll charge per dose, or give everyone the same amount once they sort out whether or not 4 doses is more effective than 1 or 2? I guess I'm bored and just want to muse about it... Part of me feels like if 4 doses...

I believe @HootOwl mentioned a couple of other drugs that are in trials hit the full frequency range. So it is possible, but the timeline & FDA current regs mean that the current formulation has to stay the same until Frequency does another special FDA trial to prove a new formulation reaches...

Pretty terrible analogies though. You compare productive things vs being homeless or imprisoned and call it a comparison of two evils? Republicans vs Democrats is more like being homeless or being homeless with a tent, depending on your demographic. You also go to jail with either party. Maybe...

I feel like we agree more than we disagree. That being said, republicans overwhelmingly voted for the Firearms Owner's Protection Act of 1986, which is the reason civilians are limited to automatic weapons created prior to 1986, effectively labeling them "rich people only". The bill was also...

Police unions condemning an officer's actions... I think it is far more likely the sun will explode tomorrow.

You don't have to believe in top-down governance as an absolute to get elected as president. The Libertarian party for example often advocates for state's rights. But both of the main two parties pretty much adapt a certain ideology and want to force everyone else to live by it. Republicans do...

Most liberals & conservatives I know both have the same narrative for their candidate of choice: "I don't like the guy, but he's not as bad as the other one." Third-party candidates are considered a joke in America, and there is clearly an agenda to keep them that way. However, if people took...

Haha ok good to hear, that take makes way more sense. Honestly, I think anyone who thinks they can take office and change things with some swooping program or a new set of laws is either insane or disingenuous. There are 350+ million Americans, how could one man in Washington (or even the few...

Or maybe it's simply not supporting either of the two parties that don't care about you. Trump & Biden are both cut from the same cloth. Creepy narcissists who would be in retirement homes screaming at their pudding cups by now if they weren't so rich & powerful. If you stand 100% behind...

"White people need to be reeducated" is also a blantantly racist statement. It's just as ridiculous as a blanket statement such as "latinos need to work harder" or "blacks need to stop being criminals". MLK said judge a person by their character, not by their skin color. This seems all but...

You normally lose the high frequencies first, which is why tinnitus is usually high pitched. If you can regenerate them, the tinnitus could go away. Also Frequency Therapeutics is planning to reformulate and hit all frequencies, not just the ones that it currently reaches. We'll know more...

Sounds extreme - I think OTO-413 or the Hough pill will become available before any drug that deliberately "finishes" off hair cells. Although, I've wondered the same thing. If we see FDA reform or the system changed entirely, we could see shortened timelines for all these things.

Would the reformulation be Cochleum AF (AF for All-Frequencies)? It's also the common abbreviation for "As Fuck", lol.

Yeah I can see this being the case, but that's still better than no one being able to get their issues fixed... Personally I'll take care of my ears regardless. Not only will the treatment be pricey, but I don't want to gradually lose hearing until the point that I need an injection again...

We shouldn't force anyone to sell anything, that wouldn't be ethical. However if we reframed the system to allow drugs to hit the market labeled as non-approved/non-vetted, companies like Frequency might then have incentive to ramp up manufacturing & sell it to healthcare providers sooner than...

I'm a huge Elon Musk fan, and I also believe 3 things are necessary for quality: Competition, accountability, & incentives. The FDA as it stands has none of these. I've made similar arguments as yours & I'm happy to see you on this forum. We should, as a people, absolutely push for a better...

Then when they reformulate to reach all frequencies: "ultimate eargasm".

Frequency has to consent to sell & also manufacture the drug. Normally it would be in a company's best interest to sell their product, but the way things are set up Frequency has more incentive to focus & prioritize resources on FDA trials instead. It's maddening, I know. I would gladly spend...

If there were some unforeseen side effect for the COVID-19 vaccine, millions in the country could suffer from it. However the Government more or less decides that we should have the freedom to take that risk because COVID-19 is detrimental and makes the vaccine available asap. They'll also pour...

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...

You can't fully analyze long term effects unless you watch trial patients until they die. That's sort of my point, we're always going to be taking a certain amount of risk regardless of how policies are set up.

Yeah, I know it could definitely be worse and genuinely appreciate your reply. This drug, and other upcoming drugs are extremely promising. They could not have existed at all or been delayed that much further. I don't want to come off as ungrateful for the possibilities here. It simply angers...

All things considered, we'd be lucky to see it hit the market in 2023. Here's to hoping for expanded use before that point... It's not only our soonest chance for relief, but is also the only part of this whole thing that doesn't seem insane. The thing is Frequency's main focus is going to be...

Super informative & reassuring! Now the only questions I have left for Frequency are: 1.) Expanded Use, yes or no? 2.) What's the plan for reaching lower frequencies? Since they've implied that is their goal. 3.) How long will this "pivotal" trial go on for? Of course I suspect all of these...

Also it's been mentioned in this thread that Frequency is measuring tinnitus levels as a part of their phase 2a study. Most agree that tinnitus is associated with hearing loss in the majority of individuals who have it... I really don't think getting FX-322 via expanded use for debilitating...

Jesus Christ, these numbers are insane. 7 years of waiting for a potentially life changing drug, after it's already been fast tracked, is asinine. FDA reform needs to happen today, not tomorrow.

That's if expanded access or breakthrough status doesn't happen, right? It seems like either of those two things could potentially make it available in 2021. I'm trying not to put too much emotion into it but sooner is definitely better than later!

In this video, his tone seems almost reversed from the last one on the subject. This makes me wonder why in this one he tells viewers to check out the previous video, but I guess it's just him being a YouTuber & wanting as many views as possible... He's gone from being almost completely...

The waiting game sucks, but we're lucky to be seeing this stuff happen in our lifetime. I believe many of us will have better hearing than we were ever supposed to at our respective ages when this is said and done. I've started to refocus on things I have control over, but check this forum...

You don't have to prove it's life threatening, only that it seriously impacts your life. As I understand it this is a simple matter of telling your physician that it seriously impacts your life. There are no other existing therapies that actually treat hearing loss, so I don't think you'd have...