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I have no idea why they are doing a Phase 2B trial because I don't know what they know. Maybe they've figured something out and are on the verge of a breakthrough. Maybe they're posturing for their investors. Hopefully the former, not the latter.

It impacts the whole study. After all, the liars weren't just put in the placebo cohort, they're also in the drug cohort. Therefore, if the drug worked, the liars get doubly boosted: whatever boost they get from the drug on top of the boost they get from the lie. But that didn't happen. There's...

Phase 2A drug and placebo groups saw improvements, and the same improvements, because they were both equally benefiting from the same flawed trial design. If the drug worked, you would expect to see improvements above and beyond the improvement experienced by everyone. It's the fact that...

There's a great deal of conjecture in this thread about what that "improvement" actually was, and I'm not sure there's anything productive about diving down that rabbit hole again. Drug trials often show early promise only to flame out in later, more rigorous trials. That's where we are with...

Thread's like a car, bro. Got to start it up from time to time or the battery dies. :cool:

What you describe (what happened) is exactly a drug showing no signal at all. If there's no advantage for the group receiving the drug above and beyond the bias boost impacting everyone, the drug has shown no signal.

Because bias, and the word score boost attributed to bias, was equally distributed between participants who received the drug and participants who received the placebo, if the drug worked, the group that received the drug would still score higher than the group that didn't because their scores...

The Phase I results have been consistently overblown in this thread. Calling a handful of people "super responders" who appeared to do well in an initial safety test is meaningless in light of a rigorous Phase II evaluation of almost 100 people in which the drug showed no signal - no difference...

No - the troubles with the outcomes appear on face value to stem from the fact that the drug didn't work. Everything else is conjecture.

I believe they said there was no difference between placebo improvements and drug improvements. Since no one knew if they got placebo or drug, both groups were equally impacted by bias, and both groups showed similar "improvement." Unfortunately, that's not a meaningless result. It suggests...

Suggesting that someone has to "believe in it" in order to weigh in sounds more like religion than science. This thread is, in many ways, about hope as much as it's about anything else – the thread that people return to in the middle of the night when they can't get back to sleep. But for it...

That would be wonderful, agreed. But they have yet to credibly establish even that. (To respond in advance: 3 people who showed word score improvements during an initial safety trial followed by a larger, more rigorous Phase II trial of almost 100 people that showed no FX-322 benefit whatsoever...

I think you should be neither optimistic or pessimistic, but rather realistic. Realistically, right now, there's no compelling evidence that FX-322 works any better than a sprinkle of sugar. However, the company continues to research it, and maybe they'll surprise and delight us with future...

Phase II results, with almost 100 participants, were devastating. FX-322 showed no signal at all, with no difference between drug and placebo. FX-322 simply worked no better than sugar water. Phase I, with a handful of participants, had a few that responded positively. In drug development...

Sure. Still, yours is a common position, widely expressed. And it's not lost on Frequency Therapeutics that a thread about the potential ramifications for tinnitus with FX-322 has been viewed over 1.5 million times.

I disagree. The marketing team is searching for a name based on meaningful building blocks, which gives insight into their thinking, and the suggestions made so far in this thread seem pretty insightful: ACUFONIQ based on "acouphène,” French for tinnitus. ECOUSTIQ based on ''écouter,” French...

As a side note, Gacyclidine, the molecule in OTO-313, is similar to Ketamine.

Answer: I don't know. Do I have evidence? No, none of us do. Can I speculate? Sure. An enthusiastic audiologist artificially guided results in a way that would please his charismatic boss waxing poetic about building a one billion dollar company. Then, the company, flush with cash, purchased an...

Of course you're right that in those circumstances it is not possible to get up from a wheelchair regardless of determination, and I wasn't suggesting otherwise. But what FGG said was "concentrating doesn't help someone get out of a wheelchair." But there are, in fact, circumstances where...

That's absolutely right. The obvious systemic agenda is to push the vaccines in order to eliminate sickness and death caused by COVID-19, and enable return to normal life.

Performance boosts and placebos can do things that have historically not been possible. Concentrating can help someone get out of a wheelchair (maybe not for long, but possible? For some people? Sure). And I don't agree that there are only two possibilities, fraud or success. "Fraud" is a...

One explanation is that the drug worked. Another explanation is that other factors were responsible. I don't know. :dunno: However, given the lack of any signal whatsoever in Phase II, it's reasonable to tilt towards the latter UNTIL Frequency Therapeutics demonstrates a response with a...

We don't know that.

Great point, well said. The issue for Phase I, however, is that we're not sure if the 3 participants who scored well did so because their hearing loss was treated, or they simply experienced a test-taking performance boost. While focus and pep talks can't treat hearing loss, test performance...

You're mistaken. Ketamine has a short half-life, around 45 minutes, and has a history of broad, safe use as an anesthetic.

Fair enough. So how hard is it to double word scores in a small group? How many words were they given? What was the interaction like between audiologist and patient? What were the circumstances? What were the expectations? Patient: "You are one of the first people on Earth to receive a...

Regarding deflated word scores, my point is that I just don't see how that impacts results as much as they indicated, given that artificial deflations would be evenly distributed. You'd still expect a bump (above and beyond whatever artificial deflation gives you) among treated participants...

Thanks for clarifying. And if I may clarify, you are a "super responder" because your responses in this thread have been super! What I'm saying is this: far too many big conclusions have been drawn by the almost meaningless positive responses from Phase I. Lost in the language of "Phase I...

Agreed. I'm not sure it's helpful to vilify participants who joined the trial at real risk to themselves, or speculate that they're "liars." It's also possible other factors influenced improvements across both treated and placebo groups. It could be that after receiving the treatments, everyone...

You've mentioned "super responders" quite a bit, but I'm not sure they exist. During Phase I, a few participants who received FX-322 significantly improved word scores. There was a tremendous amount riding on them, and a great deal of hope, not only among participants but also audiologists...

"Early onset" might distinguish from age-related (vs duration). :dunno:

I don't know that that's true. I know an increasing number of people who've received Moderna without any problems. At worst they feel crappy and their temperature goes up for a day or so. I've also talked to people who received Pfizer and also felt out of sorts following the 1st or 2nd shot...

We've created the narrative that FX-322 "cures tinnitus," and hopefully it does, but at this point, that's the theory. In practice, it doesn't even exist yet in the marketplace. More likely is that FX-322 helps some people some of the time to some extent, which is what the overwhelming majority...

I doubt it. There are currently no drugs that treat tinnitus. Assuming a drug emerges that does treat it, for example, FX-322, there is still lots of room in the market for other drugs that also treat it, treat it differently, work better with different people or under different circumstances...

I'm referring to dual purpose hearing aids that can provide relief from both amplification and white noise. Interestingly, tinnitus relief from amplification, at least to some extent, can be instantaneous. The idea is that by amplifying higher frequencies that have been damaged, the brain...

Unless I'm misunderstanding, I didn't read @Poseidon65's comment as referring to earbuds. Rather, I read it as referring to hearing aids which are commonly used to simultaneously amplify sound and generate white noise in treating tinnitus.

My understanding is that this is common and prescribed by audiologists using hearing aids to both amplify higher frequency sound (attempting to saturate lost frequencies), combined with white noise, milking every bit of relief possible from both sources.

My admittedly uninformed speculation is that a single anything doesn't matter, whether it's a single hair cell, a single cancer cell, or a single virus. Things only matter when they start to add up. I would therefore guess that we tolerate the loss of individual hair cells, but it only impacts...

Good that you're home. Take it easy and get better soon!

Scientists who study pandemics and warned about it for years.

Because we'll take the help from wherever we can get it. :dunno: If a drug provides a partial solution and a hearing aid helps on top of that, then I'm happy to pay for both. Happy to pay for any treatment that helps in any way.

How does a drug like Otividex show positive results in Phase II and negative results in Phase III? Hope that doesn't happen with FX-322.

The stock has tinnitus! :eek:

No it's not. No they're not.

I appreciate your honesty. If you don’t experience something personally, it doesn’t exist. Got it.

Could be that one of the executive's kids told them they need to do more social media :dunno:

Is it fair to say that if you personally experienced severe COVID-19, but did not personally experience severe tinnitus, your opinion would be that COVID-19 is real and tinnitus is a hoax?

From what I can gather, there's a lot of "green flags" suggesting it's moving in the right direction. However, when I ask that very question to someone in the field, they shrug their shoulders and say it could absolutely fail, as many drugs do. Truth is, while there's very real cause for...

Phase I was 9 people with severe to profound hearing loss. That first toe in the water let them proceed, but hardly shows that FX-322 is well tolerated and safe across a broader population.

Wow... sorry to hear this. Hope you and your family recover soon!

What competition? None of these drugs yet exist in the market. I honestly don't think speculative potential competition years down the line concerns them as much as the challenge of getting their own drugs out the door. By "refining study protocol" perhaps they realized they needed to tweak...

It may be that people with good experiences aren't here in the first place. Also, given the financial and logistical challenges of HBOT, it's probably not all that common. Hard to say. In my situation, my ENT prescribed it immediately, and I'm grateful for that. The research tells us that...

ASSUMING... FX-322 works, is safe, is approved, AND... ASSUMING... You invest in FREQ and make a bunch of money... ... you should use your profits to pay for the treatment. There's just a sweet logic to that. :rolleyes:

I can't speak to the specifics, and none of us are experts in any of this because it's all so new, but my own opinion, for whatever it's worth, is that the risk of worsening my tinnitus through COVID-19 is so much greater than the risk of worsening it through the vaccine, that I wouldn't...

For some, Nortriptyline and Amitriptyline do just that.

That's over 200%. Congrats! :beeranimation:

It's an exciting drug and an exciting stock once people discover it. It will likely go up and up, or crash and burn, based on subsequent reports.

ASAP: steroids, HBOT.

I'm not sure what trial you're talking about but I recall reading about a completed trial that poured Ketamine into peoples' ears through a tube for many hours that helped with tinnitus, although it was crazily impractical. Both Keyzilen (AM-101) and Otonomy's OTO-313 use molecules that are...

There seems to be a fundamental misunderstanding in much of this thread. Post after post says “when FX-322 is approved…” and “since we know it’s safe…” and “since we know it works….” We don’t. Clinical trials are literal experiments and no one, including Frequency Therapeutics, knows the...