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Why, you call him on his... shell phone, of course!

Maybe, because he was never heard of again!

You know you're flying very close to that raw sea anemone extract guy, with your seaweed theory here. Tread cautiously. You know what happened to him.

I know nothing about share trading in bio stocks, but I would suggest that Frequency Therapeutics isn't just about ears, it's about a specific type of technology called progenitor cell activation. It's a bio engineering tool that can be applied to a variety of the body's organs and nerves. It...

A fabulous opportunity for all US citizens on Tinnitus Talk, with demonstratable hearing loss, to get themselves into the trial.

Frustrating that some trials can progress so quickly, whilst others just drag on and on.

I agree with you on this. Delivery of the drug into the cochlea will be the crucial issue and I wonder if Frequency's hydrogel will be enough to do the job. If the results of the FX-322 experiment on the cochlea removed from a patient were deemed successful, but not necessarily as robust as...

Don't you guys in the US head down south to Mexico when wanting to access clandestine medical treatments?

This is going to be like watching paint dry and grass grow. I wonder if there are any Tinnitus Talk members participating in these trials.

Chinmoku was talking about Audion completing recruitment for Phase 2, not Frequency.

Did they suggest you apply for Phase 3 trials, if they go ahead, or is your hearing too 'good' to qualify?

They are looking for trial participants, if you're feeling game.

This may have been stated before, but I guess it helps to be mindful that Progenitor Cell Activation is a groundbreaking technology that is in its embryonic stages. Frequency Therapeutics has decided to choose hearing loss as its first target, but the technology is aimed at many different...

It's disappointing not to have more conclusive results of success at the first attempt. We'll need Phase 2b results to get a better handle on FX-322's efficacy, but even if it fails at that point, it may still not be over. I recall reading reports of research into nano particle delivery of...

It could get awfully crowded in there. I wonder about hearing quality and how 'natural' hearing will feel, with all these hair cells propagating all over the place.

Isn't it meant to be an extremely brief presentation? A few minutes? I can't see it mentioning tinnitus anyway. What could they say other than they're on track to positive results? Enough to keep investors happy perhaps.

They're preparing to initiate Phase 2a trials. Sigh! Does that infer a prospective 2b after that? It's all soooo slow!

So do you think that FX-322 would not be able to regrow hair cells, where they have been damaged by virus or ototoxic medications?

Next to FX-322 actually failing, this is the most frightening scenario of all. Buying out a new innovation to protect an old existing industry, especially in the realm of human health, is one of the most sinister and evil aspects of capitalism. It's really a human rights issue, but sadly, I...

Your audiogram, whilst not great, is not that bad either. Do you really need hearing aids or do you like wearing them to enhance perception of upper frequencies? Or do they actually help with tinnitus masking? I have read about Audicus aids. Have you tested them yet? How do you find them?

I wonder if getting treated with say Audion's REGAIN first, alters the inner ear in such a way, that you're not able to have FX-322 afterwards? And vice versa.

If they finish Phase 2 by the end of the year, that leaves another three years to get through Phase 3 and the approval process. That's if it's successful and there are no hold ups. That doesn't sound overly ambitious to me. But then again, anything can happen.

And if Audion is successful in Europe, perhaps four years, considering Europe's speedier approval process.

Not just Audion. If Frequency Therapeutics decided to launch from Europe, this could be out a year earlier than in the US. Unfortunately, they won't. Europe's drug approval process seems to be a little more streamlined than the FDA for some reason.

Interestingly, I have read researchers state that although drugs that regenerate hearing are readily available, the problem is getting them into the ear in sufficient quantity and long enough to take effect. No doubt this is the challenge for Frequency Therapeutics too...

I appreciate your summary here. I wonder if these sorts time scales would necessarily apply to a drug candidate such as FX-322, since it is not a systemic, regular or chronic use medication. FX-322 seems to be a very short term drug administered once, maybe twice, or even say three times and...

Fast Track Status would be nice.

David Lucchino is such a big cochlear tease!

Nothing is released to the market until it goes through the full three phase testing regime and is proved viable following peer review. Everything else is just talk!

Shouldn't Frequency Therapeutics actually put something out into the marketplace before they start receiving awards for their work?

No fear in this gang about anyone muscling in on their turf either. And I would've thought their industrial intelligence would be pretty good! https://www.prnewswire.com/news-releases/global-hearing-aids-market-forecast-2019-2027-300733841.html The other thing to remember is that Frequency...

It's frustrating to know that a room full of business execs and probably a few business journalists would have been given a prospectus and advised of some preliminary results in those conferences. How else are you going to get investors to hand over 42 million dollars? Yet we must wait for...

If I understand this correctly, the Phase I/II is still really an extended safety study. They may well have an eye on efficacy too, but the question is, will efficacy be actually reported on in the final results? If it is, then great, but if they don't, that means there'll be no efficacy...

I feel your urgency, but 2020 is a little keen, considering its 2019 and we still haven't seen one iota of evidence indicating any sort of clinical efficacy on human hearing or tinnitus. The tinnitus community actually needs an influential, paid lobbyist to work the halls and offices of...

A crucial question. If you can stand trawling through all of this thread or the Hearing Loss Regeneration thread, I recall that issue being discussed.

This is a genuine concern. In the world of diabetes research, I've read that one of the three main pharma companies that market insulin to the public has successfully bid for and purchased the technology called islet capsule transplantation. An innovation that promises diabetics freedom from...

Thanks for this. @lymebite, there's nothing like a bit of direct action, no matter how small, to make one feel even a fleeting sense of doing more than simply languishing helplessly. I hope maybe we can let Mr. Gottlieb know that one of the US government's biggest compensation costs are the...

Do you mean the needle actually hitting the fine bones of the middle ear and damaging them or that the chemical could actually alter the bones' functioning? Could they include you again for latter phases considering they found you an acceptable candidate for the first ones?

Tinnitus is pain. Physical and psychological. Just different in form to say, a toothache or a sore knee. It is not part of a properly functioning healthy human body. As such, those with moderate to severe forms of the condition, will leave claw marks on the doors of treatment centres, in an...

Don't tell me I have to be grateful to Trump for anything to do with Frequency Theraputics fixing our ears. I'm still knitting my 'pussy hat'.

For hair cell regeneration, if it works in humans and trials go well, about five years. Phase one starts in second half of 2018. Fingers, toes and eyes crossed!

Yes, I agree. Maybe it has something to do with the fact that Cochlear Limited, one of the three suppliers of cochlear implants to the US, is based in Australia and the trial will be performed on prospective adult CI recipients. A connection there somewhere.

I suspect most of us would kill for a 20db improvement. Especially if it somehow corresponds to an equivalent reduction in tinnitus annoyance.

Unless you're a military veteran. I can't see the government choosing to pay out over a billion a year, whilst a possible tinnitus treatment is out there, off label or not. Join the Army and save!

That's depressing. That means that hair cells completely wiped out along with their supporting cells in upper frequencies, causing profound deafness in those regions, may mean that tinnitus will not be eliminated, if loss in those frequencies is its cause.

@NatureHiker, are supporting cells frequency specific? If one has mild to moderate hearing loss up to 8khz, but likely more profound loss over 8khz, does that mean that only hair cells below 8khz may be able to be regenerated, but above that nothing will regenerate. Or will it mean that if one...