Frequency Therapeutics — Hearing Loss Regeneration

That @Toby1972 guy was pretty much jumped on when he tried to warn us about fishy stock movements a month before results.

It really doesn't matter and is human nature to defend your only hopes for a normal future.

I always wish there was good news when I visit the research threads.
The reason why he was jumped on is because he said stuff like "I have a rich gf" and stuff like that. He comes across as a snob.
 
It's a silly thing to be arguing over really but anyone who's been here for a long time can remember people being stomped on for being too 'negative'. The greatest stomper of course was JohnAdams. Don't ask me to trawl through 600 pages to find examples.
 
The marketing was different back then than it is now.

Stanford Cure for Hearing Loss... A cure for hearing loss in 5 years. Then it became a cure for hearing loss in 10 years. Then everyone came out and said, hey this is a lot harder than we thought. Then the trials GenVec started and everyone started getting optimistic. Then they failed.

Then the FX-322 trial started and everyone got optimistic again. And the outcome is still not clear. Now most of the people that were positive have turned negative after years of promising lab studies turning into nothing. Doing searches now, the word "cure" is no longer used anywhere as it relates to hearing loss.
 
It's a silly thing to be arguing over really but anyone who's been here for a long time can remember people being stomped on for being too 'negative'. The greatest stomper of course was JohnAdams. Don't ask me to trawl through 600 pages to find examples.
At the same time, I can't really blame people on here looking to get their hopes up instead of information.

Treatment for inner ear hearing loss still consists of hearing aids and CIs, basically technologies that have been around for 50-60 years that do nothing for the underlying problem. It's like aspirin for migraine. People are pissed off about that, and with good reason.
 
The marketing was different back then than it is now.

Stanford Cure for Hearing Loss... A cure for hearing loss in 5 years. Then it became a cure for hearing loss in 10 years. Then everyone came out and said, hey this is a lot harder than we thought. Then the trials GenVec started and everyone started getting optimistic. Then they failed.

Then the FX-322 trial started and everyone got optimistic again. And the outcome is still not clear. Now most of the people that were positive have turned negative after years of promising lab studies turning into nothing. Doing searches now, the word "cure" is no longer used anywhere as it relates to hearing loss.
And yet here we are with a better understanding of how the inner ear works every day and multiple companies pursuing treatments. Maybe we'll get hearing protection drugs first - of which the regeneration field will benefit tremendously in terms of drug delivery - but if we can believe the scientists hearing regeneration will become a reality someday.
 
The marketing was different back then than it is now.

Stanford Cure for Hearing Loss... A cure for hearing loss in 5 years. Then it became a cure for hearing loss in 10 years. Then everyone came out and said, hey this is a lot harder than we thought. Then the trials GenVec started and everyone started getting optimistic. Then they failed.

Then the FX-322 trial started and everyone got optimistic again. And the outcome is still not clear. Now, most of the people that were positive have turned negative after years of promising lab studies turning into nothing. Doing searches now, the word "cure" is no longer used anywhere as it relates to hearing loss.
The irony here of course is that we've come full circle. Back then we were trying to keep people's expectations to a realistic and probabilistic level because the talk of a cure being imminent (or terms that inferred that) were happening far too frequently based on the in vitro and animal studies.

Now some are wondering why expectations are so high? It's the complete opposite of how it used to be, but at least the discussions are based on reality and not fantasy. Some of the stuff that was discussed was way out there and demonstrated a complete lack of knowledge of how the pharmaceutical industry works, and how the world works, for that matter.
 
The reason why he was jumped on is because he said stuff like "I have a rich gf" and stuff like that. He comes across as a snob.
I can't remember talking about my girlfriend, especially not about a rich girlfriend. My girlfriend is rich, yes, enough in kindness and love in spite of my health misery.

And I'm certainly not a snob. I have already done a lot of voluntary work for clubs, I am helpful, my friends describe me as committed and infinitely patient. Although I am an ambitious boss, my employees are loyal and almost ALL 13 of them are friends with me.

I'm not a snob, just a poor guy who wants to get back to his 4/10 tinnitus when he was one of the most relaxed people on this planet here. I just want to banish my 9/10 tinnitus, which haunts me all day.

When some mocked me when I warned that the share price was about to fall, which came shortly afterwards, I didn't mock anyone. No, I'm not a snob. I myself was a damaged investor from the tech stock market bubble 2000, which is why I am more than cautious about daring increases in weak facts.

I would only have saved a few from financial loss if I had been listened to. No, I'm not a snob.
 
I can't remember talking about my girlfriend, especially not about a rich girlfriend. My girlfriend is rich, yes, enough in kindness and love in spite of my health misery.

And I'm certainly not a snob. I have already done a lot of voluntary work for clubs, I am helpful, my friends describe me as committed and infinitely patient. Although I am an ambitious boss, my employees are loyal and almost ALL 13 of them are friends with me.

I'm not a snob, just a poor guy who wants to get back to his 4/10 tinnitus when he was one of the most relaxed people on this planet here. I just want to banish my 9/10 tinnitus, which haunts me all day.

When some mocked me when I warned that the share price was about to fall, which came shortly afterwards, I didn't mock anyone. No, I'm not a snob. I myself was a damaged investor from the tech stock market bubble 2000, which is why I am more than cautious about daring increases in weak facts.

I would only have saved a few from financial loss if I had been listened to. No, I'm not a snob.
Point proven.
 
I can't remember talking about my girlfriend, especially not about a rich girlfriend. My girlfriend is rich, yes, enough in kindness and love in spite of my health misery.

And I'm certainly not a snob. I have already done a lot of voluntary work for clubs, I am helpful, my friends describe me as committed and infinitely patient. Although I am an ambitious boss, my employees are loyal and almost ALL 13 of them are friends with me.

I'm not a snob, just a poor guy who wants to get back to his 4/10 tinnitus when he was one of the most relaxed people on this planet here. I just want to banish my 9/10 tinnitus, which haunts me all day.

When some mocked me when I warned that the share price was about to fall, which came shortly afterwards, I didn't mock anyone. No, I'm not a snob. I myself was a damaged investor from the tech stock market bubble 2000, which is why I am more than cautious about daring increases in weak facts.

I would only have saved a few from financial loss if I had been listened to. No, I'm not a snob.
Okay, but can we call you The Bobb from now on?
 
Point proven.
Communicating on a message board has its advantages and disadvantages. An advantage is that you can calm down, gather your thoughts and punch them keys. A disadvantage is that you can't see the person that you're communicating with.

So you could be well-advanced in years and experience and have deep feelings about class and station in society or you could be a teenie-bopper who has little experience of the markets -- or something in between.

But point 1]. When people load up on a risky speculative stock, the stock price rises and the profits begin to look mouth-drooling. But they are only paper profits at this stage. Once the first punter (let's say Bobb) gets cold feet and decides to sell out the stock price begins to tumble. It's understandable or maybe only human that his actions fill the remaining stock-holders with buyers' remorse. But that's the market. But what did you want him to do? Lose along with all the other m.of.o.s (members of ordinary society). He read the tea-leaves right and came out with his ass clean.

2]. I very nearly got in myself and now that I look back, I was being tempted by greed -- and also a sense of duty and solidarity to my fellow cell-mates in the tinnitus community. We all want to break free of this. But the lock-down here made it difficult to locate and converse with a broker about the ramifications of investing ii the US and mask-wearing etc. and to sum the guy up.

3]. The enthusiasm and expert knowledge of some of the posters had me enthralled at how medical technology had progressed. Playing the market looked to me more like a slam-dunk rather than a pump-and-dump. $16 to $55? Sign me in immediately. I'm hoping still that it's something more like the first. We'll all be wiser in a year or two.

4] It's good that someone market savvy is at least talking about other models of investing, such as crowd-funding.

5] There have been some little-noticed but great posts of late. I'll have to look back over for them. But long story short: The notion that reconstructing the inner-ear/cochlea will alleviate tinnitus/hearing loss certainly looks plausible, but it's one big assumption.

It could be that the cochlea takes the first hit from noise/virus/ototoxic agents. But like a billiard ball or snooker ball it travels along the table and hits the next one which hits the next one etc. until finally you've got not only a damaged cochlea, but also a ringing somewhere inside.

What could this snooker ball be? Maybe inflammation, another article today suggests it's to do with declining blood-flow to the brain. It might be progress that some of the scientific community are looking elsewhere.
 
Exclusion Criteria:

1. Subject has previously been randomized in a FX-322 clinical trial.

Conflicting information?
Didn't they say in their press release that they have already given someone a dose? So yeah, they were contacting people before the trial was posted.
 
Clinical Study Sites
New York, New York
New York, New York (Actually NJ)
Albany, New York
Amherst, New York
Richmond, Virginia
Norfolk, Virginia
Winston Salem, North Carolina
Novi, Michigan
Cincinnati, Ohio
Orangeburg, South Carolina
Charleston, South Carolina
Milwaukee, Wisconsin
St. Louis, Missouri
Tampa, Florida
Sarasota, Florida
Omaha, Nebraska
New Orleans, Louisiana
Oklahoma City, Oklahoma
Dallas, Texas
Fort Worth, Texas
San Antonio, Texas
Colorado Springs, Colorado
Tuscon, Arizona
St. George, Utah
Fresno, California
Palo Alto, California

Seems like a lot of testing sites for 124 subjects.
 
Seems like a lot of testing sites for 124 subjects.
I speculate it is for 2 reasons.

One is that it is another way to mitigate bias by diversifying across more testing sites and the second reason being they are probably looking to make up for lost ground due to the last failed phase 2 trial and speed things up by only needing each site to enroll no more than 5 patients each.
 
Clinical Study Sites
New York, New York
New York, New York (Actually NJ)
Albany, New York
Amherst, New York
Richmond, Virginia
Norfolk, Virginia
Winston Salem, North Carolina
Novi, Michigan
Cincinnati, Ohio
Orangeburg, South Carolina
Charleston, South Carolina
Milwaukee, Wisconsin
St. Louis, Missouri
Tampa, Florida
Sarasota, Florida
Omaha, Nebraska
New Orleans, Louisiana
Oklahoma City, Oklahoma
Dallas, Texas
Fort Worth, Texas
San Antonio, Texas
Colorado Springs, Colorado
Tuscon, Arizona
St. George, Utah
Fresno, California
Palo Alto, California

Seems like a lot of testing sites for 124 subjects.
Where did you get that list from? I only see the 3 sites on the ClinicalTrials website.
 
Well this looks like there might be some new information in this one.

"At the event, Frequency's clinical leaders will provide a detailed review of data from nearly 170 subjects dosed with FX-322. A rigorous statistical analysis of these clinical data uncovered the patient populations most likely to benefit from FX-322"

Also are they referencing a new drug or just a different protocol?
  • A new candidate to treat sensorineural hearing loss that delivers a regenerative therapeutic that may provide greater coverage and increased potency at the site of action within the inner ear, that may enable the treatment of different SNHL patient populations at varying dose levels
https://frequencytx.gcs-web.com/new...utics-virtual-rd-event-detail-fx-322-clinical
 
Where did you get that list from? I only see the 3 sites on the ClinicalTrials website.
More information --> Additional information link

https://www.clarahealth.com/studies/hearing-study

Another thing

Exclusion Criteria: Evidence of or previous diagnosis of auditory neuropathy, traumatic brain injury, "central" hearing loss, or "genetic hearing loss".

Is that not incredibly vague? How can you even confirm if you have genetic hearing loss? Pretty much all of us have probably been exposed to loud music/noise, probably certain drugs, or just the effect of aging on hearing.
 
Frequency Therapeutics Virtual R&D Event to Detail FX-322 Clinical Advances, a New Program for Hearing Restoration and In Vivo Data from its MS Remyelination Program

https://investors.frequencytx.com/n...utics-virtual-rd-event-detail-fx-322-clinical

"Company to Introduce a Second Hearing Restoration Program with a Differentiated Biological Profile and Greater Coverage into the Cochlea, Providing Potential to Expand Addressable SNHL Patient Populations"

Sounds like they have their next generation version of FX-322.
 
More information --> Additional information link

https://www.clarahealth.com/studies/hearing-study

Another thing

Exclusion Criteria: Evidence of or previous diagnosis of auditory neuropathy, traumatic brain injury, "central" hearing loss, or "genetic hearing loss".

Is that not incredibly vague? How can you even confirm if you have genetic hearing loss? Pretty much all of us have probably been exposed to loud music/noise, probably certain drugs, or just the effect of aging on hearing.
I suppose you can draw the same conclusion as if your grandma was not able to have children, then your mother was not able to have children and now it's you in the same situation, well this is clearly genetic. The same goes for hearing. If your grandma was deaf, ...
 
Is that why Frequency Therapeutics had successful outcomes/measures from both in vivo and their single dose trials then?

That doesn't flat out demonstrate that the drug did not work.
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 from placebo.

On the face of it (your term), the reason a drug doesn't show any signal is because it doesn't work.

Everything else, all the poetic explanations (over-watering the grass, participant bias, etc) is speculation, theory, marketing, spin. And maybe one of these speculative explanations might turn out to be true, wouldn't that be great!

But let's be honest. The drug didn't work.

And where we are now is simply hoping that this very talented team of drug developers can develop something real, something that does work, from their early promising leads.
 

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