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Does anyone know the status? Has the clinical trial started yet or will it be later this year?

All testing locations in Korea, so the best we'll be able to do is monitor their progress.

I can't get excited about studies with mice. When they actually inject humans and get the same results, let me know.

I so badly want to believe in this, but every time I get my hopes up, it always fails. What they say in the press release sure does sound promising. Here's to hoping this one works!

No one has any reports? What happened at the event?

It says he plans to test two drugs. Does anyone know which drugs those are?

No updates on the 3rd Inner Ear Disorders Therapeutics Summit just held in Boston several days ago?

Has anyone heard of this? https://www.browardentaesthetics.com/services/ent/stem-cell-for-hearing-loss-and-tinnitus/

Has anyone heard of this? https://www.browardentaesthetics.com/services/ent/stem-cell-for-hearing-loss-and-tinnitus/

Are you absolutely sure about that?

So, they are testing the hearing in some of the patients?

So, we're gonna have to wait a year just to see if there are any side effects from FX-345, but they won't be measuring effectiveness?

So they probably won't be adding more sites then?

It says they're enrolling only 36 people for the trial. Damn that's low!

I hope they add more sites because none of them are near me. Otherwise, this is very exciting.

If FX-345 can reach far down the cochlea, is there any way it can reach the vestibular system? Does anyone know how that works?

Would the technique used by FX-322 also be able to regrow vestibular hairs?

God, the anticipation is killing me. I wonder when they start trials. January? February? March?

Just wanna say I love you guys...and I hope FX-345 works ❤

I went on ClinicalTrials.gov and couldn't find it. I wonder when they plan on rolling out trials.

Man if these drugs turn out to be a bust. It looks like they are going to wait until they release the results of the FX-322 trial before they start the FX-345 one.

Well, they've got all their heavy hitters on the card. But what I really want to know is when is the FX-345 trial going to start. Because I don't know why else they would hold a conference now before the results of the current trial are known.

Has anyone heard any update about FX-345?

I guess no news for October. I didn't think they generally started trials during the holiday season, so I'm not sure what to expect for November and December.

This is Q4 bro. I'm hoping something happens this month.

Are Frequency Therapeutics still planning on starting the FX-345 trial this year? Has anyone heard anything? Starting to get worried...

I wish they would tell us when the FX-345 trial will begin.

Here's their response: Hi ..., It was a pleasure speaking with you this afternoon. I received confirmation from our clinical team that we received a two-year extension to file results for this trial, so results may not be posted until 2024. Best regards, Alesha

It says the study is done on ClinicalTrials.gov. I don't see any mention of an extension. I'll call next week and see if I can get an update.

Any new information? Do they say when the FX-345 trial will begin?

I talked to the receptionist at Pipeline Therapeutics today and they said they are releasing the results at the end of June on ClinicalTrials.gov.

Just 1 more month!

I wonder how long we'll have to wait for this therapy; years, a decade?

It says age-related heay loss. Would it also work for sudden hearing loss due to loud noise?

Just 2 more months.

Just as long as they stick to the timetable. These delays prolong my depression. Just imagine if they actually start injecting people with this stuff in the fall. It's not that far away.

The IND for FX-345 should be filed soon, correct? I don't want anything derailing the first trial beginning in the fall.

God, I hope so. We really need some good news. I am so tired of this s*^!

@Diesel, can you take a look at my audiogram? https://www.tinnitustalk.com/posts/629802

That's why I am asking. If the exclusion criteria is the same for FX-345, we are fucked. I am hoping they will open it up for people with more hearing loss and not just base it off of word scores. Or else, I am never going to be accepted into any of their trials. My word scores are just too...

Are they going to have for FX-345 the same exclusion criteria as FX-322? If your word scores are too good, will you be rejected from the FX-345 trial as well? If this FX-345 meant for people with more hearing loss, you would think they would ease up so more people could get into the trial.

@Diesel, @Contrast, and others: Could someone tell me if I have any conductive hearing loss? And is my loss mild or moderate? Thanks.

Can you take a look at my audiogram in the FX-322 thread and tell me what's what? My audiologist is basically useless and just says I have mild hearing loss. Can you tell if I have any conductive hearing loss? Is it just mild?

Their exclusion criteria makes my head hurt. If you have mild to moderate hearing loss, FX-322 should be able to use your progenitor cells to regrow completely new hair cells, theoretically restoring hearing. I noticed on their exclusion criteria, they list: "Any conductive hearing loss of...

Does FX-322 regrow both inner and outer hair cells, or just inner? What if you have outer hair cell damage, but not inner? Would this drug still work for you?

So if my synapse is fine but the hair cell is dead, does this mean Pipe-505 won't help me? Is Frequency my only chance?

Can someone answer me this: if I am ineligible to be in their trial due to having too good word scores, does that mean I'll have to wait until it's released to the open market, or would I still be ineligible?

I know this has been talked about before, but with their supposedly unique delivery system that can reach all the way to the end of the cochlea, I think this drug should fully repair hearing due to sudden noise exposure. A direct quote from their July 2020 press release: "The dual mechanism of...

They won't. The first one won't be for another year, in late 2022. It will probably take almost another year to run the trial and release the results, sometime in late 2023.

Not too encouraged by the results... 4 out of 31 is a very small subset.

Rejected from the new FX-322 trial because, get this, my hearing is too good..when will the suffering end?

Apparently, they are basing eligibility on word scores.

Shit, I was denied. Because my word scores were 100%, they said I wasn't eligible; even though I have hearing loss. This shit is so aggravating.

Has anyone been able to get into the new FX-322 trial?

Anyone get into the new FX-322 trial?

Did anybody get into the new FX-322 trial?

It looks like the summer of 2022 is when we will have the results to all of these studies; PIPE-505, FX-322 severe trial and now OTO-413. I don't know how much longer I can wait. Every day just drags on, knowing we might be so close to a cure.

It says quarter 2 of 2022 for the clinical study. That's very soon. Maybe I should hold off trying to get into the current trial for FX-322. This new drug sounds much better. EDIT: Oh wait, it says IND in Q2. So, I guess the clinical trial is not until later in the year. Fuck.