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"The Phase 2a interim results also showed an unexpected apparent level of hearing benefit in the placebo group that did not occur in previous trials and exceeded well-established published standards, potentially suggesting bias due to trial design." I wrote here already a year ago that there...

It is interesting that they are stating right after their IPO that "FX-322 designed to enable hearing in higher frequencies". If they mean that it works for higher frequencies but not lower then it narrows down hugely the therapeutical range and market potential. I wonder if they disclosed that...

That is a good question. There is still a share price stabilisation mechanism (overallotment) ongoing following the IPO so current price probably does not yet fully reflect freely traded price. As the share price is at the lower end or below IPO price range it is likely that underwriters have...

I am surprised that so little has been commented here about the valuation. IPO valuation reflects what the founders, investors and advisors (Goldman, JP Morgan, etc) believe is the current status, upside and risks of development of FX-322 and also the rest of the pipeline. According to the...

I am not suggesting anything but just quoting a general definition of in vitro which is “happening outside the body in artificial conditions, often in a test tube”.

That is called “in vitro” not “in vivo”. In vitro is performed in a test tube or elsewhere outside a living organism. In vivo is taking place in a living organism for example living human. In the prospectus it states that they have tested human cells in vitro. From the IPO prospectus: “We...

It is proven to grow hair cells of living mice but not living humans. Pre-money valuation of USD 425 million is very attractive if you believe it will work. There is huge upside if they can prove efficacy. On the other hand it is a bit disappointing that they don't see more value in the business...

You are convinced that having Astellas as an investor guarantees success in curing hearing loss :) You should definitely buy Frequency Therapeutics stock. Just beware that the general statistical probability through clinical trials to approval is around 10%.

There was no change in audiogram so according to Occam’s razor the most obvious cause is something like bias. Bias is the intentional or unintentional adjustment in the design or conduct of a clinical trial that may affect the results. For example selection bias. The simplest solution is most...

After researching it for over 40 years you would think they have more than: “…may contribute to their speech comprehension and control”. It is very easy to test your theory with a home studio and a pair of Genelecs. Cut 250 – 8000 Hz just below your word comprehension threshold. Then boost...

Someone can check my math since I have not spent more than five minutes on this. 4 patients out of 15 treated with the drug got about 110% increase in word scores. Since the average increase for all 15 patients was 30% it means that the remaining 11 patients got no increase in word scores. The...

This is what it says in the IPO document: "The drug diffuses into the cochlea and is expected to create the greatest concentration of drug in the high frequency region of the cochlea." Frequency Therapeutics tested hearing up to 8000 Hz in the clinical trials. Some people on this site suggest...

You can think yourself how much would you be prepared to pay for Frequency Therapeutics share in two scenarios: 1) Drug is safe, 2) Drug is safe and effective at curing hearing loss. Scenario 1 is interesting and scenario 2 is one of the biggest breakthroughs ever in medicine. Like I said IPO...

The question is does Frequency Therapeutics truly believe in FX-322? The IPO value of the business would be at least 10 times higher after completion of successful phase 2 so from financial perspective it doesn’t make sense to IPO it on the verge of a presumed breakthrough. Current owners have...

What you are essentially saying is that safety is far from confirmed.

I don't think it is negativity to be disappointed when a hearing loss drug has no impact on audiogram. Your reasoning is pretty much based on that the dose used in the safety studies was "really really small". I thought that the purpose of phase 1 was to determine maximum dose with accepted...

You are not convincing if you are suggesting that word score results were due to improved hearing in ultra high frequencies. Why are you denying the situation? The fact is that there is no change in audiogram in their clinical trials. No one wanted this but it is better to accept the facts.

Or maybe the Japanese quarter is 25 years and they have more time to wait than us here suffering of tinnitus and hearing loss. There is always option value in the technology and no one is saying that it can not work after further development. It's just much more unlikely after their recent...

You joined a discussion chain in which it was claimed that frequencies up to 16000 Hz are needed to distinguish words like bike, Mike, hike, etc. It was also suggested that word scores in the clinical trials improved due to improved hearing in the frequencies that were not tested ie 10000-16000...

It looks like you copied and pasted p-value definition from somewhere so I am still not sure you really understand it. Many statisticians view the small sample size (e.g. 20) is not large enough to test statistical assumptions. The deletion of a single patient’s data can reverse the...

You are suggesting that audiogram no longer is the standard method for measuring hearing loss. Extraordinary claims demand extraordinary proof. Where is the extraordinary proof?

Can you guess why Frequency Therapeutics completed the audiogram tests in the clinical study up to 8000 Hz and not up to 16000 Hz?

I am not missing anything. You did not not read what I just wrote. I only explained that there may be chance involved in word scores. You seem to have a deep belief in p-values. Can you explain what p-value means? What is your take on the sample size?

I was showing ways how word scores may be unreliable especially when you have low sample size. Some patients may move faster on the learning curve than others or maybe there is something else going on. There must be a reason why word scores improved but the reason can’t be improved hearing as...

This is what Wikipedia says about human speech frequency: “The voiced speech of a typical adult male will have a fundamental frequency from 85 to 180 Hz, and that of a typical adult female from 165 to 255 Hz. Thus, the fundamental frequency of most speech falls below the bottom of the "voice...

I am not sure exactly what kind of word score tests they used but I have completed them in the past and my experience is that there is a learning curve involved. At first you don’t answer unless you are totally certain what you hear. Then after multiple tests you start to figure out what type of...

That is not statistically significant. Most of the patients didn't get any impact on any of the tested frequencies. I wanted them to succeed as much as you do but the audiogram results don't lie. They are trying to hide this fact by diverting attention to word scores which is pathetic.

You are correct and it is very strange that so many people here are in denial about it. Hearing loss drug that has no impact on audiogram does not need "just some fine-tuning" but requires another 10+ years of development to make it work, if it will work at all.

Drug safety is dose-dependent. Think about for example paracetamol which is a safe pain killer with recommended doses but higher doses can cause fatal liver damage. It is kind of hard to see what is the point of safety trials if in the following trials they immediately increase the doses several...

What a terrible day this is really. This is a worst case scenario come true. For years people here have been begging that Frequency Therapeutics shares something about the efficacy of their drug. Now we know the reason why they have been quiet: there is nothing interesting to be told. No...

This is a major disappointment, there is no way around it. Majority got no improvement in audiogram and some got 10 dB which is far from curing hearing loss. 10 dB is not statistically significant but rather a typical fluctuation between audiograms over time for someone with at least moderate...

It is not only about Frequency Therapeutics and their publications. Discussing tinnitus and hearing loss is very therapeutic and it is a comforting feeling that you are not alone. I am grateful we have sites like this as nobody close to me has a clue about life with tinnitus and hearing loss.

If there is a will there's a way. We got nuclear submarines and a man on the moon... It is a question of resource allocation.

This is a bit off topic but it would be great to get similar imaging as above done on your own hearing hair cells. Does anyone know if that is possible? Then you could get confirmation that the problem is missing hair cells and maybe even find out which exact frequencies are gone instead of...

Coordinating hundreds of scientists, tendering and negotiating a global out-licensing deal at the same time takes a lot of resources as well.

I hope that this new licensing deal, $80M USD new capital and Astellas' contribution adds sufficient resources for the development of FX-322. Maybe they can speed up trials by adding Japanese and European facilities and patients. Somebody sent a link earlier stating Frequency Therapeutics has 14...

So Astellas has global rights for development and commercialisation except for the US for which Frequency Therapeutics is responsible. I hope it will be truly global effort and not just Japan. But very good news and a strong validation for the technology by a large pharma that has seen all the...

Maybe you’re right, maybe not. Breakthrough designation has to be for life-threatening disease. It does not mean that the treatment itself is a breakthrough so the name is very misleading. https://en.wikipedia.org/wiki/Breakthrough_therapy It has been used for cancer, fibrosis, HIV etc. It has...

So the breakthrough designation shortens the drug approval process in average about 3 years. I am wondering would it help to gain a breakthrough designation from FDA if there was a petition signed by a substantial number of people with hearing loss and tinnitus? I am just thinking if there is...

Thanks! My “analysis” was just a statistical estimation based on a median of wide variety of drugs approved and should be read only in that context. Key message is that a breakthrough designation speeds up the process by several years -> median to approval from 8 years to 4.8 years. I have also...

Here is my most humble effort to try to estimate how long it would take statistically to FDA approval and how the “fast lane” speeds it up: Of drugs approved between 2012 and 2016, candidate medications with standard approval processes took between 6.5 and 10 years to proceed from the start of...

Could you clarify what you mean by "The articles I have been seeing are now saying 12 to 18 months... We will see if that happens, but that is fast."? My understanding is that when granted a fast track status a drug developer still needs to complete ordinary phase II and III studies but the...

If "improvement" means 2 dB then it is scientifically interesting, if it means 20 dB then the founders will become multi millionaires and get a Nobel Prize ;)

While this is very positive news I get a feeling that Frequency Therapeutics is falling behind in schedule compared to REGAIN. They stated this a couple of months ago: "We can share that we have successfully completed the Phase I safety study and will start the Phase II efficacy study within the...

How does one know what is the ultimate cause of their hearing loss? Is it possible to find out if the cause is nerve related or loss of auditory hair cells? I have wondered why is it so hard to take images of the hair cells and conclude what is left and what is gone. I mean it's possible to...

In addition, improvements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients. “While the focus of this study was safety, we are excited to see initial results in sensorineural hearing restoration as there are currently no treatments to...

That clip can be found on YouTube and has a date August 23rd, 2017 so it's not new.

Isn't this clip from 2017? He sounds like the cure is just around the corner and makes wonder what have they really achieved since? Did they ever publish formally the phase I results with details? I thought it was due early this year.

Nice clip, thanks for posting! Fast tracking plans confirmed which is good. Does someone know why they would need to inject multiple doses? Not sure if it is a relevant question though.

Frequency Therapeutics must maximise profits and value from the technology as they have already raised some 90MUSD from external professional investors. Owners of these investors look to get max profits back as is common sense. Drug development is very very risky and failure ratios from phase 1...

Good points. What I was trying to say is that the big news is that they got an external new investor who has seen all the data and after analysis decided to invest into Frequency Therapeutics. In general, when looking at early stage medtech companies it is best to look at third party validation...

I am not sure what kind of results people are expecting as it's only safety trials that are being completed. I doubt that much more is said than that it has proven to be the well tolerated, safe, etc. The important news is that they managed to get 42MUSD new funding from investors who have had...

A financing round like this is always a validation for the technology/drug development in a way that the venture cap investors get full disclosure of all the available data to date. It is great that Frequency Therapeutics is now fully funded but the selection of investors leaves a bit puzzled...

That is really great news! For sure those investors have had access to a lot more data than has been published and they decided to invest so the data must be convincing. Frequency Therapeutics has many venture cap investors as owners currently and it is very likely that if successful FX-322 will...

If we only knew what is considered by them "significant"... 10 dB or 40 dB... ;)

I am not too familiar with FDA processes but I read that a drug development company might get fast tracked if it is for a life threatening condition or if the drug addresses an unmet medical need which currently does not have available treatment. It sounds logical that solutions for life...

That is great news!!! Did they get already an EU approval for the completed safety trials? I guess that is the assumption if they are already recruiting for phase II. It would be really interesting to get just any information on how many decibels Frequency Therapeutics and Regain have managed...

It is really interesting that two completely unrelated entities are using small molecules trying to cure hearing loss and it's almost like a validation that this is the way to do it. Regain's development is moving ahead about the same pace with Frequency Therapeutics with both expected to end...

Current trials are to evaluate the safety of FX-322. I agree with you and hope there are no negative effects but that is what Frequency Therapeutics has to evaluate to get FDA clearance for Phase 2a. And to evaluate safety they need to set up the trials so that potential negative effects are...

My understanding is that the reason for excluding people with a hearing loss of greater than 70 dB is that they want to measure both the positive and negative effects on patient's hearing. And if the hearing loss is severe (>70 dB) to begin with then it will be difficult to measure the potential...