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Anything getting in the way of hearing can cause tinnitus.

They were wrong, fixing the issue fixes the symptoms.

While I agree that synaptogenesis and hair cell regeneration will be the "cures" for a lot of tinnitus sufferers (most likely NIHL and SNHL), OTO-313 is a powerful NMDA receptor antagonist that actually binds, so there is a pretty good chance it could help a lot of people.

By vehicle I mean their slow release gel, since it's proprietary. I think they are injecting that + some unknown substance that may look similar to the actual drug. I agree, having a sustained release placebo is kind of dangerous but it's the only way to do it. I don't know if they can even...

It's probably the vehicle + something else. They can't use saline since it would compromise the blinding of the trials.

Too many fancy words! Drugs either work or don't work, period. Stop trying to woo us with your science talk.

Dude you have to stop. You didn't get in the trial. I'm sorry but we told you so. Even if you did get in, there was a good chance you would have gotten placebo. Move on.

If anything, strict exclusion criteria makes the chances for the drug to be successful so much better.

How's that our fault? Also, we already went through this, you can re-read the old responses.

The line between chronic tinnitus and acute tinnitus is still somewhat unclear. We don't know how it can help us. We can't "think" about this stuff. We have to wait and see the clinical trial results.

It could still help us very very much, even if not a cure, if it reduces the intensity/severity, we could cope better.

@Frequency Therapeutics. There are now 2 Pharmaceutical Companies that have identified multiple injections as detrimental to the therapy itself. @FGG, @Diesel, what do you make of this?

So Frequency Therapeutics is sitting on some $200M, how much does Otonomy have?

Does the 2023 date take into account the recent sale of shares that @Pero1234 talked about?

Do you know why? Auris Medical states on their website that they are still working on it.

Good thing Otonomy is being very selective. Did AM-101 trials do as well as OTO-313 trials have?

Correct me if I'm wrong but doesn't this one have a very good chance of approval? They don't need to regenerate anything, they just need to prove it relieves tinnitus above placebo.

So the worse your tinnitus is, the better a responder you are? That's great.

Yeah that's not how it works.

Whatever they are doing to it, it's causing problems. Poor Chris.

Probably the vehicle in my opinion, intratympanic injection don't usually worsen tinnitus. Is this a confirmation that @ChrisBoyMonkey got placebo?

Yes, that's what they submitted to the FDA, there's no secret criteria. And not that it's any of your business but I have been in 2 clinical trials.

I hope those people read this message and re-evaluate trying to sign up for the trial, especially when they clearly don't fit the criteria.

You don't get it at all, do you? I won't waste my time anymore trying to explain it, just know that if you do get in the trial you're screwing everyone here.

Every trial needs parameters. Even if they suspect the drug helps with chronic tinnitus, they can't just say "everyone is welcome to come and try it". They need to establish windows and effectiveness and a whole lot of other things. It's easier to prove your drug does X in Y time than saying it...

Well typically tinnitus can only be dealt with on a pre-clinical setting as acute, since they're giving it to animals and trying to revert it. I don't think we should write off any drug, even if the drug itself is marketed as for "acute tinnitus only" since we don't really know the mechanism of...

Absolutely not, stick to the trial parameters. Don't lie about your tinnitus duration.

Please do not enroll. Look at the FX-322 fiasco, you're way out of the recruitment parameter.

So is this dead?

Why wouldn't it work for chronic tinnitus?

@FGG, what are the cons of OTO-313? Does it deplete support cells?