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Because it is based off another drug that was apparently quite effective for tinnitus but unfortunately had too many side effects and had to be pulled. The idea is that they have tweaked it enough to ditch the side effects but remain effective against tinnitus. I think...

Didn't Trobalt pass a safety test, only to reveal major side affects later on?

Has anyone heard how this thing went?

Yeah you're absolutely right. It's just that if you had the type of blood cancer the new drug didn't help, it would be personally disappointing. However, if you were just an impartial observer, any progress is incredible. Everyone was hoping FX-322 would fix all the hair cells it touched and...

I agree. There was a lot of emotion riding on good results. All I'm saying is that people need to recognize when emotion is in the driver's seat.

Yeah, possibly! Again, remember when he showed up and so many people jumped down his throat and aggressively mocked him?

Wow, I feel dumb. You are right. I read it as "previously undisclosed". This got less exciting. Now it sounds like they're just trying to salvage the lackluster results of one of those old studies.

Without investing too much emotion, this seems like a good sign. Basically a secret trial that if it had bad results, would be swept under rug. I know people will point out the possible sketchiness of the scenario but this is promising!

"The greater good" is exactly why they did it. That is why they are known as the "greatest generation". They knew the risks but also knew what had to be accomplished. You couldn't get most 18-24-year-olds today to delete their TikTok accounts. Anyway, let's not derail this thread lol.

Imagine if the soldiers on D-Day were like "I'm not storming the beach on the first day! I'm not one of those suckers who are possibly gonna get shot! I'm just gonna wait until it gets all cleared".

I can't be bothered to bring up the exact numbers and percentages but I remember that if you really looked at the numbers, there was only a small percentage of people that had the room to get better by an amount that could be classified as statistically meaningful. So it actually was a decent...

Agreed. At least prior to the Phase 2a results, all the available evidence looked very favorable. Coming out against it was more based in pessimism. Now they have single dose studies that can't live up to the assumptions set by the safety study.

I am on the side that thinks restoring input to the brain can lessen/stop tinnitus, at least sometimes. However, I do appreciate your scrutiny as I agree with the "echo-chamberish" comments. I've seen people in the thread repeat blatantly false information that sounds promising and these same...

Ahh ok, cool. Thank you very much for the explanation!

Sorry, so what's the take away from this? Thanks!

I've honestly never been super optimistic about the multi dosing hitting lower frequencies, it just never made sense to me. Full disclosure, I do not have any qualifications to even warrant an opinion that challenges the beliefs of the brilliant minds who are working on this drug.

After seeing this post, I bought a pair and I really like them. I can wear them all day and still talk to people with no issues. They take the edge of loud noises for sure while barely losing any speech. I wouldn't replace more generic silicone earplugs with these in places like concerts, loud...

Thanks for the breakdown. I subscribe to the idea that the drug, in its current delivery form, does repair hearing to a limited but still remarkable extent. At least relative to what's currently available. Phase 2a wasn't a failure of the drug, just a failure of a trial.

I think this is positive. Everything pointed at single dosing giving limited but solid results and they kind of jumped the gun with their Phase 2. Better they prove a drug works half decently and gets released, as for the first time people have a possible repair. I think they really thought...

Same. I also noticed that the popular understanding of IHC and OHC changed. Until the Phase 2 results were released, everyone was saying that the OHC were for higher frequencies while the IHC were for lower frequencies and found deeper in the cochlea. The theory was the OHC were reached while...

Completely agree. It's the idea of it getting worse that I worry about. If it was frozen or whatever so it never gets any worse, that would be good enough for me. Though of course, a reduction or elimination would be amazing.

So wait, is this kind of like Lenire or whatever in that it tries to reset a part of your brain, except by using some sort of pink noise input plus an already existing/approved drug? And if it works, they'll know in 6 months and be able to commercialize it soon afterwards to some capacity?

I think the progress was that they learned some new things that gives them a good foundation to go further.

I agree. They already tried to fly too close to the sun with their gamble on multi-dosing for their Phase 2 and it cost them. Stick to what seems to work, get it to market and then start messing around with improvements after.

I definitely understand your disdain for information silos, echo chamber etc and I can definitely see it happening in this thread from time to time. At the same time, I do think there is good reason to be optimistic about a limited benefit that FX-322 may provide. No, it won't give everyone...

Exactly. It should still benefit mild hearing loss and that is displayed in the detailed Phase 1/2 results. It's just that the ceiling doesn't allow for the definition of "clinically meaningful" etc to be achieved and that's nothing to be concerned about. If you consistently score 46 out of 50...

Yeah the thing about mRNA, from my understanding, is that it's relatively simple to program your desired result. This means that the process of trial and error can be greatly expedited. This means zeroing in on medical fixes can occur much much faster.

I probably don't know what I'm talking about, but it seems like they are suggesting that a therapy for tinnitus can be created by introducing specific RNA, which may fill a void which is responsible for the tinnitus reaction some people have?

Honestly, any improvement is great for the not-severely compromised person. It may give lots of people a second chance who maybe went to a few too many concerts unprotected or used a table saw a couple too many times. Anything that makes having hearing issues go from "sorry, nothing can be...

So you're saying it's kind of like a "slow and steady wins the race" kind of thing? Like "get good, then go fast?". Couldn't they just have done pretty much the same thing and call it Phase 2 and if it works out, they get another Phase out of the way and if it doesn't, they're at the same spot...

How does this speed up clinical study process? Legit question because to my uneducated brain, it seems like a redo of a previously favorable Phase is just taking up more time.

Yeah but that's basically just saying that the new hair cells regrow completely. A hair cell without a synapse is like having a cell phone without a network connection. Hair cells need that synapse to work properly. Without it, the new regrown hair cells wouldn't be very useful. What can often...

Yeah exactly. It seems like they are quietly walking back on the benefits of FX-322. If the Phase 1/2 results are truly indicative of what it does in its current form, that's great but I'm worried those results were inflated for whatever reason. My fear is fuelled by the omission of details on...

That's all very cool and promising stuff! Seems like every week, we are receiving more and more news that how the science world is starting to bring hearing issues out of the medical stone age! The changes and advancements made in the last few years are insane. There was basically no movement...

I think it depends on what your issues are. For me, I have no issues until the end of the audiogram and even then, it's not a crazy dip, just enough to identify as hearing loss. The dip likely continues in the extended range. This long, continuous moderate loss in the extended frequencies is...

Alright, cool. Glad we are on the same page haha.

Sure, here are some screenshots from the previous page. Maybe this is also a case of everyone misunderstanding everyone. But these are some of the posts that indicate people thought there were audiogram improvements from Phase 1b-111. As long as everyone is aware that there is no...

People were saying that the audiogram of the Phase 1b-111 also had 10 dB improvement at 8,000 Hz. All I want is for people to know that is false, so that expectations are tempered. Apparently this information was stuff everyone knew for 2 months. That sounds like a lot of misinformation for a...

OK. This isn't providing any details that I'm trying to get at. Maybe those details don't exist yet? Fine. I'm just saying be cautious if there are no details. Also, where are the audiogram improvements that so many people have been parroting? Why has nobody addressed this?

I'm talking about the Phase 1b study that everyone has been quoting as "successful" because it replicated the same results as Phase 1/2, which apparently is the 111 study. Still, nobody has provided audiograms, despite constantly saying people's audiograms improved. They keep referring to the...

So can anyone provide the audiogram data from Phase 1b? Or do we now admit that people were just repeating completely false information?

Yeah. I mean, maybe since it looked at "mild to severe hearing loss", they actually did replicate the same results as Phase 1/2, when broken down by the status of each individual's hearing. When looked at vaguely, Phase 1/2 isn't that impressive. It's only when you look at the broken down data...

I did read the slide. Unless I'm totally off, it seems to refer to Phase 1/2. Where does this 2 month old information that audiograms improved in the recent Phase 1b study come from?

That's Phase 1/2. I'm talking about Phase 1b. I know Phase 1/2 was successful and in my opinion, it was great. I'm concerned about this second "successful" Phase, mainly because the first one had tons of data that when broken down, shows how good it was. Phase 1b simply says "34 percent had 10...

Where do you see them mentioning any kind of audiogram improvement? They only mention some word score improvements. I'm all for the theory that multiple dosing neutralizes the benefit but we have to be realistic with the second single dose study, which so far to me seems not nearly as...

So I 100% think the Phase 1/2 results are very promising because when you look at the data, the people who had room to improve a lot, all improved a lot and the people who had room to improve a little, improved a little. I think it looked amazing. The only thing unfortunately missing was that...

Sorry, I must have missed something. What are the two successful single dose trials? I only know of the Phase 1 safety trial from a couple of years ago. What are the Coles Notes of this second trial?

Your synapses are likely damaged. You have also lost hair cells. Both drugs that regenerate either synapses or hair cells will give you some benefit. It is argued that synapses are even more fragile than hair cells and may play a larger roll in hearing than they are credited for. Point is...

I think it is safe to assume that most people with tinnitus have a few issues wrong and fixing one issue can provide at least partial relief. So even if you have significant hair cell loss plus synapse damage, fixing one issue could provide a decent amount of relief. In some people, even fixing...

Yeah, without going down the rabbit hole of wishful thinking theories, that's what it sounds like. However, the fact that now this massive company is pursuing hearing loss is awesome. As @Lukee mentioned, this is a sign of a whole new attitude towards hearing loss. The door has been cracked...

Success is NOT a straight line. Several tests and experiments showed that one dose works to a certain degree. One test showed that multiple doses doesn't work. Ok cool, 1 dose it is. To write it off because an ambitious experiment didn't result in overall success is pessimistic. If the results...

Yeah the way I see this, is that multiple dosing is likely the reason for the fail, assuming the first phase wasn't a scam. I think the chances that fakers could have tanked the test so badly is very small. So I think that they will pursue the 1 shot dose, confirm that the first phase wasn't...

From what I've read, shocks from headphones are just static shocks due to a variety of reasons. But just in case a shock did damage your hair cells, I'd assume that the hair cells affected would benefit. If the reason for auditory issues is related to the hair cells, this should help.

It cant hurt to try. The more people who contact them, the more attention it gets. The more attention it gets, the better. Squeaky wheel gets the grease!

I hope you are able to get this done! Your story and situation sounds horrible. I'm confident that this drug can at least make a significant increase in people's daily lives.

Yes they are doing multiple dosing on humans. I do not think this is a concern. It only explains why they didn't maybe do multiple dosing on animals before humans? Either way, a tiny mouse ear is likely more physically fragile than a human ear, so maybe they determined that. In my opinion, it's...

I personally believe that you are actually going to be ok. As people have pointed out, you had some protection right away and quickly got doubled up. As correctly pointed out, that doesn't mean 45 dB protection, probably closer to 25 to 30 dB. I think the "subtract 7 and divide by 2" is more of...

Based on the definition of what constitutes "significant" and "measurable" in a clinical setting, milder cases simply do not have enough room to improve in order to be classified as "significant" or "meaningful". Imagine they are at 90 percent but in order to be "significant", the patients have...

Found the thread she talked about it in: https://www.tinnitustalk.com/threads/silence-after-4-5-years-medications-from-company-called-decola.43227/

I wouldn't let that concern you much. His statements have to be conservative in order to avoid legal trouble. Assuming everything goes smooth, it looks like 2023 to 2025 for a FX-322 release. "Within 5 years" leaves no wiggle room but "within the decade" is uncontroversial. It generates...