Frequency Therapeutics — Hearing Loss Regeneration

[tommyd87]

The timeline of up to 10 years before deployment was depressing for someone my age (just turned 50) but it's better than having nothing to look forward to.

I think @serendipity1996 has made a valid point about this being potentially the maximum timeframe for FX-322 to be released.

It appears as if Frequency Therapeutics is again being conservative with their estimates and it is not an actual indication of when the product might be released.

Not even Frequency Therapeutics know what might happen with certain factors which influence the drug development process like the FDA approval and also manufacturing. Then there are other issues which could be faced like drug reformulation.

Frequency Therapeutics have been very conservative and also very transparent throughout the process and I believe that this is simply another example of this.

 

[reeseth]

I'm 42 and feel this too.

Yeah 38 here, I believe regardless of age we feel the same. Some are just starting their lives, some are right in the middle and some are looking for a peaceful retirement. All different but still the same...

 

[Billy_Shears]

I think that it can benefit people positively and I also actually think that it is a positive sign observing Frequency Therapeutics engage with many stakeholders. Still I feel that just like I explain below why doctors might be initially unwilling to treat patients, I also feel that there might be the same sort of apathy also from doctors.

If it is successful (and I think it will be successful), I believe that there will still be problems with convincing many ENTs to treat patients with FX-322 initially. I reckon that there will be a mixture of skepticism and refusal from some. Others however will obviously be willing to treat.

The most likely obstacle patients may face is finding a doctor who would be willing to work with them for the duration of their course of treatment. FX-322 is inevitably going to be a treatment that requires a lot of investigatory and also trial work to get the treatment right, especially in the initial stages. Thus this will not be something that many doctors will want to take on because it will be time consuming and not necessarily simple for them like deciding to do ear tubes. Furthermore it may be less financially beneficial for them when compared to other treatment options they could provide.

Thus I believe that until doctors either

- recognise the benefit in providing FX-322 treatment to people

or

- there are improvements in the ease of delivering FX-322 to patients and these improvements clearly result in the treatment becoming simpler to administer to people

There will be quite a lot of apathy for doctors to administer FX-322 or even learn about it so they can actually administer it.

For example doctors in Australia consistently refuse or resist to learn new procedures until there is a demonstrable benefit to them or some other reason for doing so. I assume this happens in other places also. As a result I feel that until Frequency Therapeutics can lay the ground work and actually convince doctors to treat using FX-322 there will be a barrier for patients to be able to obtain treatment.

You have a good point as it relates to Australia and the same would be true for Canada and Great Britain as well, but I do not think this would be the case in the United States. There will be ENTs nationwide involved in Phase III treating a few thousand participants. These physicians are specialists and often treat an immense number of conditions that are routinely complex and they're good at it. They are just as encouraged with the prospect of FX-322 benefits as we are. The good news in the United States is that the government does not provide or is involved in providing health insurance in any way to working Americans. It is issued privately through the employer and finding an ENT to help treat mild-moderate sensorineural hearing loss with FX-322, when it comes to market, I can guarantee will not be a problem.

 

[FGG]

You have a good point as it relates to Australia and the same would be true for Canada and Great Britain as well, but I do not think this would be the case in the United States. There will be ENTs nationwide involved in Phase III treating a few thousand participants. These physicians are specialists and often treat an immense number of conditions that are routinely complex and they're good at it. They are just as encouraged with the prospect of FX-322 benefits as we are. The good news in the United States is that the government does not provide or is involved in providing health insurance in any way to working Americans. It is issued privately through the employer and finding an ENT to help treat mild-moderate sensorineural hearing loss with FX-322, when it comes to market, I can guarantee will not be a problem.

There is absolutely no roadblock in the US (other than something they could be sued for) to a doctor dispensing any drug on or off label if a patient is willing to pay for it when insurance doesn't (insurance doesn't cover hearing aids so it's probable they won't cover this either).

 

[tommyd87]

Any ideas, if FX-322 is successful, when will it be available on the market? I thought people were expecting 2023-2025 but is that hugely unrealistic?

It is impossible for Frequency Therapeutics or outsiders to exactly predict when FX-322 is going to be released because it is like trying to guess what bingo numbers will get drawn. Everyone knows Frequency Therapeutics has always been ultra conservative with their statements and are always very cautious in their approach.

I believe that there are two main factors that can be considered though when trying to evaluate this.

> Firstly no one knows whether there are going to be any unforeseen delays or hurdles that Frequency Therapeutics will face.

This could relate to a number of issues such as medicine manufacturing, the need to reformulate the medicine and any potential problems faced with gaining regulatory approval. Any one of these may delay progress with launching the treatment because it is obvious that these need to be completed first.

> What your definition of getting it on the market actually means.

If you are referring to getting FX-322 on the market with full FDA approval (meaning completing phase 3 trials, all other regulatory compliance requirements and completing manufacturing and distribution), then 2023-25 would be an accurate time frame if there are no roadblocks.

From what Frequency Therapeutics have indicated in their dialogue to stakeholders, it is possible that 2023-25 is around the time frame that FX-322 might be released with full approval not only in the USA but in other jurisdictions too. The clinical trials in Asia and Europe aren't slated to start until at least a year from now, noting what Frequency Therapeutics has said. Furthermore it would probably take a maximum of four years to complete the required trials that need to happen.

However this doesn't mean that there won't be scope to obtain FX-322 earlier. The ability to obtain medicine off-label well before the medicine is officially approved by the regulators is a completely different story. Therefore if this is what you are referring to when you say "on the market" then one can predict that it may happen sooner than 2023, as effectively Frequency Therapeutics are almost at the point where they can assess whether they apply for off-label use.

Thus I believe that it is inevitably going to take at least three or four years to get FX-322 delivered to market as a fully approved product. However I do believe that there will also be a significant likelihood that there will be scope to obtain FX-322 earlier.

 

[serendipity1996]

You have a good point as it relates to Australia and the same would be true for Canada and Great Britain as well, but I do not think this would be the case in the United States. There will be ENTs nationwide involved in Phase III treating a few thousand participants. These physicians are specialists and often treat an immense number of conditions that are routinely complex and they're good at it. They are just as encouraged with the prospect of FX-322 benefits as we are. The good news in the United States is that the government does not provide or is involved in providing health insurance in any way to working Americans. It is issued privately through the employer and finding an ENT to help treat mild-moderate sensorineural hearing loss with FX-322, when it comes to market, I can guarantee will not be a problem.

If this were initially only available in the United States, would it be possible for those of us from other countries (I'm from Great Britain) to receive treatment with an ENT in the United States? I know medical tourism is a thing but not really familiar with the ins and outs of it.

 

[FGG]

If this were initially only available in the United States, would it be possible for those of us from other countries (I'm from Great Britain) to receive treatment with an ENT in the United States? I know medical tourism is a thing but not really familiar with the ins and outs of it.

Yes. Foreigners can get drugs in the US by seeing a doctor in a US clinic.

 

[Rubenslash]

Of course he's conservative. Management from publicly listed companies is always conservative, they risk law suits if it turns that their predictions are too optimistic.

I think there's a possibility that FX-322 will be available within the next 5 years. Nevertheless still frustrating considering that the actual product has been "ready" since at least 2017... These trials take way too long when you are suffering and - at least in my opinion - it's pretty clear that the product is safe. Don't forget that somewhere in 2018, they already injected FX-322 in people that were getting a cochlear implant and as far as I know, no negative side effects have been reported more than 2 years after treatment. So just give me the damn product lol.

 

[Gb3]

There is absolutely no roadblock in the US (other than something they could be sued for) to a doctor dispensing any drug on or off label if a patient is willing to pay for it when insurance doesn't (insurance doesn't cover hearing aids so it's probable they won't cover this either).

My insurance covered my hearing aids.

 

[FGG]

My insurance covered my hearing aids.

What insurance do you have? When I tried them (they didn't work for me) I was told I would get zero coverage for them.

 

[Lucifer]

Of course he's conservative. Management from publicly listed companies is always conservative, they risk law suits if it turns that their predictions are too optimistic.

I think there's a possibility that FX-322 will be available within the next 5 years. Nevertheless still frustrating considering that the actual product has been "ready" since at least 2017... These trials take way too long when you are suffering and - at least in my opinion - it's pretty clear that the product is safe. Don't forget that somewhere in 2018, they already injected FX-322 in people that were getting a cochlear implant and as far as I know, no negative side effects have been reported more than 2 years after treatment. So just give me the damn product lol.

This is what sickens me that the product has been ready since 2018 but it won't be getting released in the market till after the clinical trials finish which will be in a few years time. I could be cured right now but I have to suffer until it comes out. This ain't fair at all.

 

[tommyd87]

Of course he's conservative. Management from publicly listed companies is always conservative, they risk law suits if it turns that their predictions are too optimistic.

I think there's a possibility that FX-322 will be available within the next 5 years. Nevertheless still frustrating considering that the actual product has been "ready" since at least 2017... These trials take way too long when you are suffering and - at least in my opinion - it's pretty clear that the product is safe. Don't forget that somewhere in 2018, they already injected FX-322 in people that were getting a cochlear implant and as far as I know, no negative side effects have been reported more than 2 years after treatment. So just give me the damn product lol.

There is also the fact that FX-322 needs to be "approved" and approved for use by the FDA.

"Approved" means that the treatment can now be used off label by people.

Approved means that Frequency Therapeutics has been granted complete FDA approval to distribute FX-322.

It is obvious that Frequency Therapeutics is being conservative and there will be no disagreements from anyone about this. Though the types of comments that Frequency Therapeutics are making also seem clearly geared towards reflecting the FDA timeline and requirements. These are far more prolonged when compared to the time it might take to be able to obtain FX-322 off-label.

 

[GlennS]

just give me the damn product

Visuals required.

 

[Born To Slay]

There is absolutely no roadblock in the US (other than something they could be sued for) to a doctor dispensing any drug on or off label if a patient is willing to pay for it when insurance doesn't (insurance doesn't cover hearing aids so it's probable they won't cover this either).

My insurance covers hearing aids, I think quality insurance plans do. Although Medicare doesn't.

 

[weab00]

What's the estimated cost for FX-322 once it hits the market? >$10,000? I'm willing to pay a loooot to eliminate tinnitus, but I also don't want to be super in debt. I will probably get it regardless, just curious.

 

[Diesel]

Of course he's conservative. Management from publicly listed companies is always conservative, they risk law suits if it turns that their predictions are too optimistic.

I think there's a possibility that FX-322 will be available within the next 5 years. Nevertheless still frustrating considering that the actual product has been "ready" since at least 2017... These trials take way too long when you are suffering and - at least in my opinion - it's pretty clear that the product is safe. Don't forget that somewhere in 2018, they already injected FX-322 in people that were getting a cochlear implant and as far as I know, no negative side effects have been reported more than 2 years after treatment. So just give me the damn product lol.

In all of the few hundred thousand years of thousands of generations of humans or human-like beings existing on earth, none have ever had hearing that could be regenerated. Now, we're all alive with the first ever treatment to restore hearing may be 5 years away. I'm willing to wait.

 

[Piney]

Not all insurance covers hearing aids though, most don't. Not all ENTs will take your appointment unless you have American insurance. That being said the US is big and has a lot of ENTs, shouldn't be a problem to pay cash somewhere.

 

[FGG]

My insurance covers hearing aids, I think quality insurance plans do. Although Medicare doesn't.

I have BCBS but it's not a PPO. Hearing aids are not covered.

 

[tommyd87]

There is absolutely no roadblock in the US (other than something they could be sued for) to a doctor dispensing any drug on or off label if a patient is willing to pay for it when insurance doesn't (insurance doesn't cover hearing aids so it's probable they won't cover this either).

In theory could a doctor be sued for negligence if they prescribed a medication off-label to treat a condition that it hadn't been approved for by FDA?

I ask this because Frequency Therapeutics approach to FX-322 being used off-label and Hough's approach to its pill being used off-label are completely contrary to each other. This is despite both Frequency Therapeutics' and Hough's medicines being theoretically able to treat other conditions to those that they will be FDA trialled and also approved for. Thus both would be candidates for off-label prescription.

Frequency Therapeutics stated that while they won't allow FX-322 to be used off-label (including early access) at this time, there also do not appear to be any barriers present which may prevent off-label use being granted in the future.

On the other hand:

Hough won't allow their pill to be used off-label in any form and has said that a FDA compliant tinnitus study must take place prior to its use. This is because doctors could potentially lose their licence and potentially be sued due to negative outcomes stemming from using its pill to treat conditions it isn't FDA trialled for. Hough has also stated that this is why they need to fund a tinnitus study/trial.

I see Hough's reasons why they can't allow off-label use as being quite far-fetched from a legal perspective.

This is because:

- if the medicine is safe (FDA requires this to be demonstrated before it can even be prescribed off-label)

and

- there is evidence to show that the medicine is effective to treat the condition it is being prescribed for (even if it hasn't obtained final FDA approval)

I cannot fathom how a doctor could get sued for negligently prescribing Hough's pill off-label.

Even a report into testing the pill's effect on tinnitus as a secondary measure (like what Frequency Therapeutics is purportedly doing with tinnitus in phase 2) which shows favourable results would surely be enough to absolve a doctor from being deemed negligent in prescribing Hough's pill off-label. This is because they can reasonably and fairly rely on this information to support their decision to prescribe it.

Thus I would like to know do companies and doctors actually require sound evidence such as completed FDA trials to demonstrate that it is acceptable to prescribe a medicine off-label to someone for a specific condition to avoid getting sued?

or

Can a medicine be prescribed off-label to treat a condition providing a doctor knows it is safe and is actually unlikely to have any adverse outcomes?

I just find it incredibly interesting that there are two approaches being applied to off-label use here with one entity claiming that the off-label use requirements are a lot more stringent then they actually appear to be.

 

[Billy_Shears]

There is absolutely no roadblock in the US (other than something they could be sued for) to a doctor dispensing any drug on or off label if a patient is willing to pay for it when insurance doesn't (insurance doesn't cover hearing aids so it's probable they won't cover this either).

Your statement in and of itself is absolutely true and there are physicians you may find who will just sign off on it with or without insurance. However, many if not most primary care physicians require that you have health insurance just to get an appointment and then be diagnosed to get the medication. Sensorineural hearing loss that would involve non-invasive treatment to the cochlea would require a referral to a specialist (ENT physician) who would for sure require that you have adequate health insurance before providing any care and receiving FX-322.

Most often, private employer-paid insurance plans cover, in part, disorders of the ear that may include surgery or in-office non-invasive treatment. Some individuals are fortunate enough that their insurance plan covers hearing aids especially if the hearing loss is severe. Most often, however, health insurance companies do not recognize hearing aids as a legitimate 'treatment' for hearing loss and that is very unfortunate but true.

It is only in my opinion that socialized medicine like that in Australia, Canada, and Great Britain, for example, may have some issues with FX-322 in the early years with providing this at any level of magnitude. Of course, I may be wrong.

 

[FGG]

In theory could a doctor be sued for negligence if they prescribed a medication off-label to treat a condition that it hadn't been approved for by FDA?

I ask this because Frequency Therapeutics approach to FX-322 being used off-label and Hough's approach to its pill being used off-label are completely contrary to each other. This is despite both Frequency Therapeutics' and Hough's medicines being theoretically able to treat other conditions to those that they will be FDA trialled and also approved for. Thus both would be candidates for off-label prescription.

Frequency Therapeutics stated that while they won't allow FX-322 to be used off-label (including early access) at this time, there also do not appear to be any barriers present which may prevent off-label use being granted in the future.

On the other hand:

Hough won't allow their pill to be used off-label in any form and has said that a FDA compliant tinnitus study must take place prior to its use. This is because doctors could potentially lose their licence and potentially be sued due to negative outcomes stemming from using its pill to treat conditions it isn't FDA trialled for. Hough has also stated that this is why they need to fund a tinnitus study/trial.

I see Hough's reasons why they can't allow off-label use as being quite far-fetched from a legal perspective.

This is because:

- if the medicine is safe (FDA requires this to be demonstrated before it can even be prescribed off-label)

and

- there is evidence to show that the medicine is effective to treat the condition it is being prescribed for (even if it hasn't obtained final FDA approval)

I cannot fathom how a doctor could get sued for negligently prescribing Hough's pill off-label.

Even a report into testing the pill's effect on tinnitus as a secondary measure (like what Frequency Therapeutics is purportedly doing with tinnitus in phase 2) which shows favourable results would surely be enough to absolve a doctor from being deemed negligent in prescribing Hough's pill off-label. This is because they can reasonably and fairly rely on this information to support their decision to prescribe it.

Thus I would like to know do companies and doctors actually require sound evidence such as completed FDA trials to demonstrate that it is acceptable to prescribe a medicine off-label to someone for a specific condition to avoid getting sued?

or

Can a medicine be prescribed off-label to treat a condition providing a doctor knows it is safe and is actually unlikely to have any adverse outcomes?

I just find it incredibly interesting that there are two approaches being applied to off-label use here with one entity claiming that the off-label use requirements are a lot more stringent then they actually appear to be.

Off label use is very common and routine. This is a partial list from Wikipedia:

https://en.wikipedia.org/wiki/List_of_drugs_known_for_off-label_use

Viagra was originally not labelled for ED (but commonly given anyway)

Xifaxin was originally only labelled for hepatic encephalopathy (but more commonly given for IBD).

Rogaine was given orally for hair loss dispute being labelled as a blood pressure medicine and made into a topical later (and never labelled for this indication).

I get a strong impression (because of how extremely routine this is) that doctors don't get successfully sued for this if the treatment is safe or at least the benefits outweigh the risks and they keep good notes.

 

[FGG]

Your statement in and of itself is absolutely true and there are physicians you may find who will just sign off on it with or without insurance. However, many if not most primary care physicians require that you have health insurance just to get an appointment and then be diagnosed to get the medication. Sensorineural hearing loss that would involve non-invasive treatment to the cochlea would require a referral to a specialist (ENT physician) who would for sure require that you have adequate health insurance before providing any care and receiving FX-322.

Most often, private employer-paid insurance plans cover, in part, disorders of the ear that may include surgery or in-office non-invasive treatment. Some individuals are fortunate enough that their insurance plan covers hearing aids especially if the hearing loss is severe. Most often, however, health insurance companies do not recognize hearing aids as a legitimate 'treatment' for hearing loss and that is very unfortunate but true.

It is only in my opinion that socialized medicine like that in Australia, Canada, and Great Britain, for example, may have some issues with FX-322 in the early years with providing this at any level of magnitude. Of course, I may be wrong.

As a counter example, in the few years right before being eligible for Medicare, my mom didn't have health insurance. She was able to see specialists and pay for her (cardiac) care out of pocket including at Mayo. She did wait to have her ablation surgery done until after she got Medicare, though.

I realize you weren't saying all doctors but she didn't have any difficulty.

 

[ajc]

Hough won't allow their pill to be used off-label in any form and has said that a FDA compliant tinnitus study must take place prior to its use. This is because doctors could potentially lose their licence and potentially be sued due to negative outcomes stemming from using its pill to treat conditions it isn't FDA trialled for. Hough has also stated that this is why they need to fund a tinnitus study/trial.

Hough Ear Institute are a bunch of liars!

They are saying that in a desperate bid to get funding for their tinnitus study, which they should have been able to get from elsewhere, a long time ago!

Hough CANNOT DICTATE off-label usage. If a physician is willing to prescribe it off-label, they can.

@Justin De Moss maybe you can share why you're giving such awful information?

It's either @tommyd87 has misunderstood, or @Justin De Moss is spreading misinformation.

Frequency Therapeutics is correct with their statements regarding the off-label usage of FX-322 in the future.

 

[tommyd87]

Off label use is very common and routine. This is a partial list from Wikipedia:

https://en.wikipedia.org/wiki/List_of_drugs_known_for_off-label_use

Viagra was originally not labelled for ED (but commonly given anyway)

Xifaxin was originally only labelled for hepatic encephalopathy (but more commonly given for IBD).

Rogaine was given orally for hair loss dispute being labelled as a blood pressure medicine and made into a topical later (and never labelled for this indication).

I get a strong impression (because of how extremely routine this is) that doctors don't get successfully sued for this if the treatment is safe or at least the benefits outweigh the risks and they keep good notes.

This tends to make sense. So really it seems that providing a treatment is approved for use it can be utilised for a multitude of other treatments outside of its original purpose. That is as long as it is shown to work and also there is no obvious risk to the patient from taking the medicine.

Hough Ear Institute are a bunch of liars!

They are saying that in a desperate bid to get funding for their tinnitus study, which they should have been able to get from elsewhere, a long time ago!

Hough CANNOT DICTATE off-label usage. If a physician is willing to prescribe it off-label, they can.

@Justin De Moss maybe you can share why you're giving such awful information?

It's either @tommyd87 has misunderstood, or @Justin De Moss is spreading misinformation.

Frequency Therapeutics is correct with their statements regarding the off-label usage of FX-322 in the future.

Your point is clearly helpful, however I might raise this one in the thread about Hough Pill. Pretty sure someone is going to be compiling a list of questions and sending them through to have these answered. Apparently Hough is wanting to assist by providing accurate information. I could have have misinterpreted the response from Hough, however I am pretty sure I interpreted it accurately.

 

[DebInAustralia]

It's a great idea, certainly not new to us though. We've been wanting to do this for years, but it requires some serious dedication and resources to put together something truly useful and informative, not to mention easy to follow and understand.

We've tried many times to recruit volunteers to work on resources like this and invariably they will produce a little bit and then disappear (sorry if I sound cynical, but this is our experience).

You will be happy to hear though that I am working on something together with two PhD students, you can read more about it here. I am confident we'll get something good and publishable in a few months or so, but the students and myself are doing this in our spare time, so please be patient.

Hazel,

Can I help in anyway?

 

[d'Wooluf]

In the Q&A to the video, the question was asked: Would you advise patients to have a cochlear implant or wait for FX-322? The answer given by the two clinicians was basically don't wait.

Again from LeBel:

Frequency Therapeutics maintain full separation from the clinical trials.
As they progress through the trials the criteria for inclusion will become broader with each trial.

They were asked who would do the it injection. The answer given was an ENT. Not necessarily a sub-specialist in the field, but an ENT. Definitely not an audiologist.

There was a question put about volume versus clarity. The audiologist on the panel seemed to imply that increased clarity was something they deduced from the improved word recognition scores in phase 1b without fully understanding what it is. LeBel came down on the side of improvements in higher frequencies.

Asked about high vs. low frequencies, LeBel said that FX-322 targets high frequencies because of drug-delivery issues and also 'because that's the way we designed it'. He did say that he thought that some day there would be a drug that would help with lower frequencies but stopped short of say that drug was FX-322. "There are some pretty clever drug delivery folks out there"

 

[Adaś]

I'm 42 and feel this too.

I am 41 and in the same boat with you.

 

[Justin De Moss]

Hough Ear Institute are a bunch of liars!

They are saying that in a desperate bid to get funding for their tinnitus study, which they should have been able to get from elsewhere, a long time ago!

Hough CANNOT DICTATE off-label usage. If a physician is willing to prescribe it off-label, they can.

@Justin De Moss maybe you can share why you're giving such awful information?

It's either @tommyd87 has misunderstood, or @Justin De Moss is spreading misinformation.

Frequency Therapeutics is correct with their statements regarding the off-label usage of FX-322 in the future.

When I first started commenting here - nearly everyone was very welcoming and appreciated that I actually engaged rather than share stock answers and not respond at all. Many of them mentioned that very few research institutes or bio orgs would engage, and none like we did. Maybe the reason for it can be found right here.

Social media and forums are often a place for people to vent, but they do so with vile and to soothe themselves and wrap themselves in a cloth of righteousness.

@ajc - I will give you the benefit of the doubt that you didn't give me. I am assuming that you are just frustrated and tired and that is why you lashed out at me.

I challenge you to find where I said Hough would not allow off label us. When you find it - send me an @mention so I get notified. I'll wait.

Maybe I did communicate poorly. Maybe those who are suffering lost their critical thinking skills and read into the message what they wanted to hear? Let's find out.

Waiting...

 

[Justin De Moss]

This tends to make sense. So really it seems that providing a treatment is approved for use it can be utilised for a multitude of other treatments outside of its original purpose. That is as long as it is shown to work and also there is no obvious risk to the patient from taking the medicine.

Your point is clearly helpful, however I might raise this one in the thread about Hough Pill. Pretty sure someone is going to be compiling a list of questions and sending them through to have these answered. Apparently Hough is wanting to assist by providing accurate information. I could have have misinterpreted the response from Hough, however I am pretty sure I interpreted it accurately.

@tommyd87 Thank you for being more gracious about this than @ajc.

I really have no idea what you are referring to. I challenged ajc to find where I said Hough would not allow off label use. Maybe you can help him?

 

[Tanni]

Hough Ear Institute are a bunch of liars!

They are saying that in a desperate bid to get funding for their tinnitus study, which they should have been able to get from elsewhere, a long time ago!

Hough CANNOT DICTATE off-label usage. If a physician is willing to prescribe it off-label, they can.

@Justin De Moss maybe you can share why you're giving such awful information?

It's either @tommyd87 has misunderstood, or @Justin De Moss is spreading misinformation.

Frequency Therapeutics is correct with their statements regarding the off-label usage of FX-322 in the future.

Yeah, this is embarrassing.