Frequency Therapeutics — Hearing Loss Regeneration

I honestly don't see how it could fail. It restored hearing in mice, and the process worked in an explant human cochlea. It would be nice if someone could actually offer an argument as to how it could possible fail that they didn't find while dumpster diving at Taco Bell.

It may cause dysacusis however.
@JohnAdams ... Dysacusis / distortion is very plausible.

Cured mice heard something... they couldn't tell us if they heard garbled noise or crystal clear sound as before.

Let's keep our fingers crossed!

I still wonder why this feature is turned off by default in mammals system settings. What's the evolutionary logic for mammals?
 
@JohnAdams ... What's the evolutionary logic for mammals?
Where's the logic for evolution to begin with?



Besides, losing an ability would be devolution not evolution. I guess fish and birds were shooting guns in war and going to clubs for hundreds of millions of years before humans. We just need to catch up.
 
Depending on how many supporting cells are present, I don't think that the actual amount of hearing loss is relevant. If it can regenerate one cell then why not all of them? It may just take multiple treatments.

I'm not sure if we know the answer to this question. When the hearing cells die, what happens to the supporting cells? Do they also die in time? Do they remain intact? I thought the evidence pointed toward them dying once you reached the profound stage? I think that is why they don't want people that have profound hearing loss in this trial. The results wouldnt be as good as a person with moderate hearing loss that still has their cells intact. I'm in the profound range for high frequency range so I'm clinging to hope as well, but I'm staying realistic.

I'm agreed right now that it looks like this trial is going to come out with a positive outcome and I'm hopeful that this is the case. What could happen? Someone could die a week later due to other causes and the trial gets put on hold. One person could have a negative effect related or maybe not related to the trial and it gets put on hold. It could be determined that is does help, but not as much as originally suspected. We are a ways off from knowing the outcome. They are also guessing on the proper dosages. Right now, it looks like its going to do well though and we should all keep our fingers crossed that the trials go well.
 
I'm not sure if we know the answer to this question
Yes, we do. Go watch the Will McLean presentation and he answers this question at the Q and A at the end.
They are also guessing on the proper dosages.
I think they are making educated guesses from their preclinical tests on animals. I however have no exact info.
 
Scar tissue turns into supporting cells and hair cells. Also, once the hair cell regenerates, the nerves regrow and connect. Thanks Stanford university dude. @28:00

 
Scar tissue turns into supporting cells and hair cells. Also, once the hair cell regenerates, the nerves regrow and connect. Thanks Stanford university dude. @28:00



This is good to know.

I don't know if my SNHL in my left ear is hair cell or auditory nerve damage, there is a test to know but I didn't pursue it because it makes no difference at this moment in time. The ENT agreed.

If what you're saying is true then it could possibly hopefully mean this drug would hopefully be a cure for either cases.
 
Wow really good thinking which makes me think maybe they found success. Oddly I think I have some tinnitus in my left ear but I haven't been exposed to any sound recently. I have it in my right but now I'm feeling it in the left but I really can't be sure. No hearing loss over there but who knows.

Sometimes it transfers to the normal ear. I have normal hearing in my right ear but severe in the mid range frequencies in my left ear (moderate in the low and high). I've been tested for everything as well, right ear is totally normal hit still has tinnitus, happened some time after tinnitus in my left damaged ear.

It can be somatic.
 
Scar tissue turns into supporting cells and hair cells. Also, once the hair cell regenerates, the nerves regrow and connect. Thanks Stanford university dude. @28:00



Great video @JohnAdams . The whole story in 2012, still relevant today.

Finally, a scientist with presentation skills :-D A rare breed!
 
Sometimes it transfers to the normal ear. I have normal hearing in my right ear but severe in the mid range frequencies in my left ear (moderate in the low and high). I've been tested for everything as well, right ear is totally normal hit still has tinnitus, happened some time after tinnitus in my left damaged ear.

It can be somatic.
Did you take a hearing test that tests over 8 kHz?
 
Where's the logic for evolution to begin with?



Besides, losing an ability would be devolution not evolution. I guess fish and birds were shooting guns in war and going to clubs for hundreds of millions of years before humans. We just need to catch up.

Sometimes it transfers to the normal ear. I have normal hearing in my right ear but severe in the mid range frequencies in my left ear (moderate in the low and high). I've been tested for everything as well, right ear is totally normal hit still has tinnitus, happened some time after tinnitus in my left damaged ear.

It can be somatic.
It has since stopped since I wrote this. The tinnitus in my right is still there.
 
Based on my recent research into growth factors and stem cells, it looks like they figured all of this out years ago and FX-322 is just the best way to achieve this while making the most money and keeping it proprietary. That being said I also think FX-322 will work very well.
 
Some time ago I wrote to the FDA about this and today I received this email.

Thank you for writing to the Food and Drug Administration (FDA). Your e-mail of November 12, 2018, to FDA Commissioner Dr. Scott Gottlieb, regarding whether the investigational treatment FX-322 will be accepted as a Fast Track designation, was forwarded to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research for a response.

Ultimately, Fast Track designation must be requested by the sponsor or drug company. In this case, Frequency Therapeutics is the sponsor of the investigational treatment FX-322. Due to Federal confidentiality laws, the FDA is only permitted to comment on products that have received final FDA approval for marketing within the United States. Therefore, you may wish to contact the sponsor to determine if they have pursued a Fast Track designation with the FDA.

If the Division of Drug Information can be of further help or, if you have drug related questions or concerns in the future, please feel free to call us -
 
Some time ago I wrote to the FDA about this and today I received this email.

Thank you for writing to the Food and Drug Administration (FDA). Your e-mail of November 12, 2018, to FDA Commissioner Dr. Scott Gottlieb, regarding whether the investigational treatment FX-322 will be accepted as a Fast Track designation, was forwarded to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research for a response.

Ultimately, Fast Track designation must be requested by the sponsor or drug company. In this case, Frequency Therapeutics is the sponsor of the investigational treatment FX-322. Due to Federal confidentiality laws, the FDA is only permitted to comment on products that have received final FDA approval for marketing within the United States. Therefore, you may wish to contact the sponsor to determine if they have pursued a Fast Track designation with the FDA.

If the Division of Drug Information can be of further help or, if you have drug related questions or concerns in the future, please feel free to call us -
Nice work. Sadly we are plebeians and they don't discuss this stuff with us. They have already announced that they will request fast track status if they see the results they expect. If I were the FDA commissioner or the President I would form a special committee to look at this and get it out ASAP.

JohnAdams for president 2024!
 
I assume Frequency Therapeutics will do everything possible to speed this up and go for fast track at least. Though they have received financial resources in the past they are limited as far as their ambitions is concerned and they are not backed by a big pharma player. So FX-322 - hearing loss - is crucial to them to keep the rest of the portfolio they envisaged funded. Remember that research is expensive.
 
I assume Frequency Therapeutics will do everything possible to speed this up and go for fast track at least.
I have no indication yet that they arent pliable human beings like 90% of us that would take kickbacks from competing corporations to slow down or even not proceed.
 
I have no indication yet that they arent pliable human beings like 90% of us that would take kickbacks from competing corporations to slow down or even not proceed.

Do you have any indication that they have?

This sort of knee-jerk conspiratorial cynicism really isn't useful.
 
Do you have any indication that they have?

This sort of knee-jerk conspiratorial cynicism really isn't useful.
Conspiratorial? Haha what!! That's business as usual in America! Like how GM delayed the recall on their ignition switches because they didn't want to pay for it which would have prevented many deaths. Or how about how Apple got busted slowing down older phones to try and push people to buy new ones? Or how about Volkswagen got busted using special software to cheat emissions testing? Or how about the CEO of ITT Tech defrauding the federal government with lousy student loans? Yeah it's knee jerk conspiratorial thinking to assume biotech firms that are going to disrupt huge markets aren"t being approached by their competitors to make deals to soften the blow.
 

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