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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....

@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...

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....

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...

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...

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

Carl LeBel on Expanded Use during the Tinnitus Talk Podcast: "[...]firstly and importantly our position on expanded access is due to really the...

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...

@MrCrybaby I remember you saying you had similar fullness/popping symptoms to me and attributed it to middle ear muscles spasming. You expressed...

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...

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...

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...

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...

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...

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...

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...

- 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...

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...

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...

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...

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...

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....

Do you guys think that hearing restoration could also curb or possibly erase ETD symptoms? Mine started shortly after my tinnitus did, and at...

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...

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...

Individuals in the FDA probably are interested in getting it approved. I'm just saying there's a big difference between - A biotech (Frequency)...

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...

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...

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...

Pretty terrible analogies though. You compare productive things vs being homeless or imprisoned and call it a comparison of two evils?...

I feel like we agree more than we disagree. That being said, republicans overwhelmingly voted for the Firearms Owner's Protection Act of 1986,...

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...

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...

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...

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...

"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...

You normally lose the high frequencies first, which is why tinnitus is usually high pitched. If you can regenerate them, the tinnitus could go...

Sounds extreme - I think OTO-413 or the Hough pill will become available before any drug that deliberately "finishes" off hair cells. Although,...

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...

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...

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...

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...

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...

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...

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...

Yeah, I know it could definitely be worse and genuinely appreciate your reply. This drug, and other upcoming drugs are extremely promising. They...

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...

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...

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...

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....

That's if expanded access or breakthrough status doesn't happen, right? It seems like either of those two things could potentially make it...

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 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...

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...