I wish people would stop saying this. It's not going to take years. Frequency Therapeutics is moving very fast, tacking on another trial which is running concurrently with this one.So many years...
With the two clinical trials they are currently doing could mean a better chance at getting Breakthrough Therapy status and releasing it ASAP.I wish people would stop saying this. It's not going to take years. Frequency Therapeutics is moving very fast, tacking on another trial which is running concurrently with this one.
I wish people would stop saying this. It's not going to take years. Frequency Therapeutics is moving very fast, tacking on another trial which is running concurrently with this one.
I can't see Frequency Therapeutics slowing down things if the trials turn out successful. Seems that they are very keen to progress through the trials in the most effective but quickest manner they are able to.With the two clinical trials they are currently doing could mean a better chance at getting Breakthrough Therapy status and releasing it ASAP.
It is interesting that FX-322 clinical trial Phase 1b-112 and 113, which adds a much broader range of individuals to the study, is being rather condensed in an expeditious manner. Conceivably in doing so, it lessens the appeal or need of continuing with a lengthy, full-blown Phase III clinical trial.With the two clinical trials they are currently doing could mean a better chance at getting Breakthrough Therapy status and releasing it ASAP.
I agree that in an ideal world it would be 2022, but 2023 would still be a big win.It is interesting that FX-322 clinical trial Phase 1b-112 and 113, which adds a much broader range of individuals to the study, is being rather condensed in an expeditious manner. Conceivably in doing so, it lessens the appeal or need of continuing with a lengthy, full-blown Phase III clinical trial.
Unlike most other pharmaceutical and cellular clinical trials , FX-322 methodology inscribes itself only within the tiny world of the human ear with virtually zero effects on the physiology of the body as a whole. FX-322 has sent researchers a signal that in and of itself indicates a precious breakthrough in restoring clarity and normal hearing which could also eradicate tinnitus in many individuals.
My heart wants to believe that FX-322 means March, 2022 - introduction to world markets, and perhaps it is true it was an original goal on their behalf to aim for. Yet, in reality, the conclusive study from Frequency Therapeutics should begin to pay off sometime in 2023, in my opinion. That is still good news.
Why would they reformulate a drug that works? And the current trials underway use varying doses.Question: Won't FX-322 need to be reformulated or multiple doses proven to work to reach frequencies shown on an audiogram to really help tinnitus and hearing loss?
Just to make it more potent. So that it works stronger / quicker / lasts longer in the cochlea to reach more frequencies.Why would they reformulate a drug that works? And the current trials underway use varying doses.
I'd assume they'd release the regular formula to the market first and then tweak it later on.Just to make it more potent. So that it works stronger / quicker / lasts longer in the cochlea to reach more frequencies.
The below quote is what is much more likely to happen.Question: Won't FX-322 need to be reformulated or multiple doses proven to work to reach frequencies shown on an audiogram to really help tinnitus and hearing loss?
Having FX-322 reformulated now would mean more trials because they are going to need to take the new dose through things like the safety trials first with FDA.I'd assume they'd release the regular formula to the market first and then tweak it later on.
It is worth commenting that there's research which states that utilising multiple intratympanic injections is likely to lead to deeper and also better dosing.Just to make it more potent. So that it works stronger / quicker / lasts longer in the cochlea to reach more frequencies.
That's what they are planning to do.I'd assume they'd release the regular formula to the market first and then tweak it later on.
Yeah you can't reformulate something before it hits the market first, without going into trials again from scratch, but they can release it and then tweak it later on going thru express route.I'd assume they'd release the regular formula to the market first and then tweak it later on.
I think in the future they will have to focus on the delivery process and develop a way to get it deeper into the cochlea. It's not the formula, it's the depth of reaches.Why would they reformulate a drug that works? And the current trials underway use varying doses.
I don't think 2-3 years is pessimistic, though? It's rather optimistic, actually.I don't know why some of you keep saying it's going to take 2-3 years before it hits the market. In 2017 they injected it into people who were receiving cochlear implants to test for side effects. There weren't any.
In 2018 they used 1 injection and placebos on people in San Antonio to see if the drug actually worked. It must have worked because in October 2019 they used 4 injections.
When the results come out in May 2021, the only reason to have a Phase 3 would be to increase the amount of people who get 4 injections as opposed to a placebo. It's not like they would learn anything new.
That's why May 2021 is the big date. When they release the results, then we will truly know if the drug can restore full hearing. Having more trials wouldn't prove anything.
And if the drug works (as we all know it does), that changes everything. There would be no more waiting.
I don't know what is so hard to understand.
Why are some people on this board so pessimistic? 2022? 2023? Get the fuck out of here with that shit.
Frequency Therapeutics dosed their first patient with FX-322 in a clinical trial in 2017. Based on research I shared a few pages back, the average expectation of a drug gaining final FDA approval from first dosing is 9 years.Why are some people on this board so pessimistic? 2022? 2023?
Can you elaborate on express route?Yeah you can't reformulate something before it hits the market first, without going into trials again from scratch, but they can release it and then tweak it later on going thru express route.
That's because ENTs and audiologists are stuck in the 1990s when Jastreboff reigned.I don't think 2-3 years is pessimistic, though? It's rather optimistic, actually.
Rather than trying to guesstimate when FX-322 will be released to market, I'm just happy there's a continued stream of positive news.
Most of the ENTs and audiologists I've spoken to don't believe there'll ever be any cure or relief at all, so the fact that FX-322 exists at all gives me a lot of hope.
In the meantime, I'm just trying to cope the best I can. And this thread certainly helps to keep me motivated.
ENTs don't want a cure. They want you repeatedly coming back to them to line their pockets. A couple of injections brings them in a lot less money than selling you hearing aids and bullshit TRT protocols. Healthy people don't make doctors money.Most of the ENTs and audiologists I've spoken to don't believe there'll ever be any cure or relief at all, so the fact that FX-322 exists at all gives me a lot of hope.
I don't think all ENTs think that way, or I'd hope not. Seeing a lot of the ones I've seen seem to have tinnitus themselves, surely they'd want a cure if only for themselves?ENTs don't want a cure. They want you repeatedly coming back to them to line their pockets. A couple of injections brings them in a lot less money than selling you hearing aids and bullshit TRT protocols. Healthy people don't make doctors money.
Most/many ENTs and audiologists actually still think that it is not possible to get medicine into the cochlea or you cannot regrow the hair cells consequently which is incredibly indicative of how not up to date they are with what companies are doing. This has already been proven to be possible so it demonstrates their claims are not necessarily accurate. Furthermore a lot of this has got to do with the fact that there has been something worked out which has never been done before so I think some in the industry are being critical for no other reason than maintaining the status quo.I don't think 2-3 years is pessimistic, though? It's rather optimistic, actually.
Rather than trying to guesstimate when FX-322 will be released to market, I'm just happy there's a continued stream of positive news.
Most of the ENTs and audiologists I've spoken to don't believe there'll ever be any cure or relief at all, so the fact that FX-322 exists at all gives me a lot of hope.
In the meantime, I'm just trying to cope the best I can. And this thread certainly helps to keep me motivated.
This is partially true though I think the audiologists are actually the ones who don't want these treatments. The thing is that even if hypothetically FX-322 restored only the very high frequencies it is going to mean a big reduction in the type and the volume of hearing aids which could potentially be sold. This is why I think there have been examples of audiologists criticising medicines and also making unsupported or incorrect claims about why the medicine won't work because there are some who simply don't want it to work.ENTs don't want a cure. They want you repeatedly coming back to them to line their pockets. A couple of injections brings them in a lot less money than selling you hearing aids and bullshit TRT protocols. Healthy people don't make doctors money.
I am with you on this. There are three things that we know when it comes to moving forward with the clinical trials:If they do have a Phase 3 trial, I hope they do it in 2021 and not make us wait a year. I don't know how much more waiting I can do. And I'm sure there are others who feel the same.
I created my account here 3 days after this thread was started, it has been a dream since then. Good thing is, when I started reading about hair cell regeneration early 2016, they were still saying it's "decades away", unbelievable the progress that has been made since then.Anyone else dreaming of the day when we can move this thread into the Treatments category?
Forgive me for asking but phase 1b is the FX-322 trial for severe hearing loss, right? I have my eyes on that one now as I'm mostly in the severe range. I hope the efficacy results of that are also out in 2021 and not far from the May one.1. The current phase 1b and phase 2a trials should be done by mid-2021. The results need to be submitted to the FDA and there also is a lag time which the FDA has to respond
ENTs dont sell hearing aids and TRT protocols - audiologists do.ENTs don't want a cure. They want you repeatedly coming back to them to line their pockets. A couple of injections brings them in a lot less money than selling you hearing aids and bullshit TRT protocols. Healthy people don't make doctors money.
There are actually a few ENTs I have come across who support treatment. There tends to be a few who are playing it very safe though by not saying anything in public because it is incredibly likely that they are going to inflame debate and also actually create rifts with those who they have to work productively with now.I don't think all ENTs think that way, or I'd hope not. Seeing a lot of the ones I've seen seem to have tinnitus themselves, surely they'd want a cure if only for themselves?
In my country it is really certain that ENTs would jump on this treatment because it is a high return for little effort procedure. I'm pretty positive most people wouldn't whinge about getting to charge $120 to do an injection in the ear and also a small amount of consulting too before they administer the medicine. Most importantly it is illegal for ENTs to get kickbacks for pushing specific hearing aids or sending people to get certain medicines/treatments and as a result I can't see any of this compromising the ability to get treatment.ENTs dont sell hearing aids and TRT protocols - audiologists do.
ENTs dont like the word "tinnitus", they like words like ear infection, tonsils, adenoids, deviated septum, pharynx, larynx stuff like that.