Member10 years is too long, especially since the technology appears to be already developed. 10 years for Phase 3 trial and time to roll out the product? I don't see how this would be acceptable to shareholders.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
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Thuan
Member
- Jul 5, 2020
- 221
- Tinnitus Since
- 05/2018
- Cause of Tinnitus
- Ear infection right ear 2018. Sound trauma left ear 2020.
Please discuss Hough Pill in the Hough Ear Institute thread.
@Justin De Moss I have made a post in the Hough's thread regarding @ajc and @tommyd87's interpretation at this post:
https://www.tinnitustalk.com/posts/543199/
@Justin De Moss I have made a post in the Hough's thread regarding @ajc and @tommyd87's interpretation at this post:
https://www.tinnitustalk.com/posts/543199/
I wouldn't take it too personally. I think your comment about venting is very apt, and I see people do that all the time in the open source world (software development). It's really annoying, especially when you're working for the benefit of others, but most people are appreciative. I think that's true here too. And even people who are critical probably are appreciative too, they're just letting off some steam. I wouldn't let a few negative comments discourage you from interacting with the community.
Also, as an aside, I actually haven't kept up much with the Hough Ear Pill. I see you have a podcast interview with Tinnitus Talk, I'll try and check that out later.
@Justin De Moss this is what @ACJ is referring to. Tommy said Hough said it. I can understand your frustration with the accusations being thrown around. I hope Hough manages to find funding for the trial.
I think a lot of the frustration on the forum comes from many members' inability to donate due to their circumstances and that frustration bleeds out to Hough. Would be nice if an established organization would step in for the rest, because at this point that's the only real way I see the funding happen. Even health related GoFundMes struggle to really get anywhere unless ran as a story for news media, then they'll take off. It might help to have the fundraiser directly linked to the Hough front page too.
Best of luck, Justin.
In addition to the PPO/non-PPO differences, apparently there are 36 independent BCBS companies that vary by state:
https://www.bcbs.com/bcbs-companies-and-licensees
Hough pill sidestepping traditional funding and trying to effectively crowdfund is, um, strange. We're not talking about kickstarting a back scratcher here. Has there ever been any other treatment that went that route, let alone one that did so AND was successful?
The market for hearing restoration is enormous. I don't really understand having to panhandle to those with shallow pockets unless there's something about Hough, either the technology or the people behind it, that makes it difficult for them to be taken seriously by the big fish investors. I'm sure I'm not the first to have expressed such sentiment.
But the contrast between Hough and Frequency Therapeutics is stark.
Having a rep from Hough camp out on the forum and insert himself in low-level drama is also not the best optics.
Probably the best thing Hough could do is follow Frequency's model and pursue industrial VC just like everyone else and if you hit a roadblock, take it as a sign that there's something that needs to be improved.
I mean, even Neuromod's corporate operation with its buttoned-down press-releases, etc... inspires more confidence.
The market for hearing restoration is enormous. I don't really understand having to panhandle to those with shallow pockets unless there's something about Hough, either the technology or the people behind it, that makes it difficult for them to be taken seriously by the big fish investors. I'm sure I'm not the first to have expressed such sentiment.
But the contrast between Hough and Frequency Therapeutics is stark.
Having a rep from Hough camp out on the forum and insert himself in low-level drama is also not the best optics.
Probably the best thing Hough could do is follow Frequency's model and pursue industrial VC just like everyone else and if you hit a roadblock, take it as a sign that there's something that needs to be improved.
I mean, even Neuromod's corporate operation with its buttoned-down press-releases, etc... inspires more confidence.
Agreed, ten years is longgggggg. If my symptoms get worse I may have to join Allan1967 on the other side... truly.
Naive question for everybody...
Is there anything we can do collectively to get access to this drug on compassionate grounds, in a few years' time?
All of us, many of us, who post here and follow this thread are in a bad way and need help ASAP.
is there anything we can do to get access to this drug?
I want to take part in the clinical trials, as this is the only chance of getting the drug early, and I will start working to get the necessary support to get recommended... this is no easy task as I don't have a doctor, but I'm committed to getting the ball rolling with the few contacts I do have.
Did Mr. LeBel or anybody mention if the next clinical trials will be done internationally?
I apologize for my disjointed post. My brain is feeling fried... eeeeeeeeeeee.
Thuan
Member
- Jul 5, 2020
- 221
- Tinnitus Since
- 05/2018
- Cause of Tinnitus
- Ear infection right ear 2018. Sound trauma left ear 2020.
It's not 10 years. It's frustrating that many either don't listen correctly or just join the bandwagon train from a fellow Tinnitus Talk member's post. The video never said 10 years. It said the most conservative estimate - the worst case - is 5 years for phase 3 but Carl says FX-322's phase 3 is likely to take less than 5 years.
Phase 2a is almost done. I'm not sure if they'll do phase 2b but if they do it'll be another 2 years plus phase 3's less than 5 years. That does not sum up to 10 years.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Dr. LeBel said they would revisit compassionate use after the phase 2A trial after they have more data. If that turns out to be the case, this could be as early as next year.
But that aside, if you listened to the interview, he didn't say it would take a decade. He said it would "definitely be within this decade" no matter what. But then he also said you could get a better estimate if you look at Phase 3 cardiac drug studies that take 5 years but recruit thousands of patients and contrast that to Frequency Therapeutics who won't have a problem with placebo effect and can recruit and test hundreds instead which will take much less time.
In other words, if FX-322 was a cardiac drug, it would take finishing this trial and then recruiting and then phase 3 (so to about the end of this decade), but LeBel specifically said they would be much faster than a cardiac drug because they are recruiting much less.
I felt this was his way of not giving a date (which would not be a good idea in a publically traded company) but giving an extremely conservative guarantee and then providing a hint for people to get a better estimate.
As far as the trials though, they are still recruiting for this trial if you can get a US doctor but international trials should correspond with phase 3.
ajc
Member
- Feb 6, 2018
- 1,170
- Tinnitus Since
- 11/2002; spike 2009; worse 2017-18
- Cause of Tinnitus
- Loud music - noise damage
How out of the loop can you be.
@Allan1967 committed suicide. Daniel meant joining him in death.
In Loving Memory of Allan1967
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
Agreed. It's also worth noting that LeBel has mentioned in both the Tinnitus Talk Podcast and the recent discussion that they are in the "mid-phase" of development. I don't anticipate him saying this if he truly expected it to take up to 10 years to get it out onto the market.
And this is all assuming phase 3 has to happen before it goes to market. Depending on the results from the phase 2a , it could come out before phase 3. This article from the WSJ says a lot of drugs that are fast tracked end up doing that.
https://www.wsj.com/articles/fast-t...ed-for-emergencies-is-now-routine-11562337924
Theoretically FX-322 could be released next year providing there are positive phase 2 results and also expanded/compassionate access is allowed. However, I think that with the planned end date of the trial being mid 2021, Frequency Therapeutics needing to meet with the FDA and then the process of getting the drug out, it is probably going to be some time in 2022.
It is certainly not going to be 10 years and it is probably not going to even be 5 years. Full FDA approval and release (so completing phase 3 and associated requirements) might take 5 years but I feel that will also be completed sooner.
I agree with this sentiment. If compassionate use is granted, we could have access late next year or early 2022. If full FDA approval is indeed required, the process will be a bit lengthy, but no way it extends past 3-5 years. I would even go as far as to say the process would be on the shorter end of this timeframe.
I felt good about the way Dr. LeBel described Frequency Therapeutics' approach toward revisiting their compassionate use policy. After this next data set comes in from Phase 2a, we will have a verdict. Help may be on the way sooner than we think.
They know the demand for their product is enormous and people are anxious to get it. If they said 2 years and took 2 and a half years, people would be angry. If they said by the end of the decade and took 2 and a half years patients and investors would be thrilled.
His cardiac study analogy was a huge hint he does not think this will come close to 10 years.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Hi Paul,
Allan took his life. I think you were taking a break from the forum when this happened. Very sad and a reality many of us battle with as you know.
Thanks for the hugs fellow sufferers and FX-322 enthusiasts, your warm wishes and love helps. Sending love and good vibes right back at you.
What frustrates me is that FX-322 will be more safer than a COVID-19 vaccine but it will take FX-322 longer to come out. This is not fair at all. There will most likely be more side effects with a COVID-19 vaccine than a FX-322 shot.
FX-322 has already shown to be safe and effective with no side effects. I just want them to release it now.
I agree to a large extent but as terrible as tinnitus/hyperacusis and hearing loss is, it didn't crash the world economy. Until this vaccine comes out, the world essentially can't go back to normal. That means it'd be harder to get stuff like FX-322 out.
That's true. It just makes me so pissed that COVID-19 vaccine gets to come out first where there may be side effects which haven't popped up yet due to not testing the drug for years whereas FX-322 has been ready since 2018 which has shown to be safe and effective for a couple of years now.
Not true! The arrival of FX-332 onto the market is nearly right on course as planned despite the economic downturn during 2020. It will not be harder to get FX-322 because of this virus - that's pure BS. There is much to be hopeful for within the next two years when Phase III will be completed IF there is a Phase III. The U.S. economy is rebounding and the stock market is once again reaching record highs - this has a huge impact on the world economy as a whole. Frequency Therapeutics has made the needed adjustments during the current phase and are very enthusiastic about getting this treatment to the market and COVID-19 has done little to slow the process - help is on the way!
A lot to unpack here.
First of all, the release of FX-322 has already been delayed because of COVID-19. The phase 2a data was supposed to be released next month and is now being released next year, so it's not BS, that's one hell of a delay. If they were to skip phase 3, the drug would probably be coming early next year if not for COVID-19. It has delayed things and it can delay them again.
Second of all, the US economy is not rebounding. Our unemployment rate is still higher than during the Great Recession, millions are at risk of eviction, millions of people are food insecure and millions have lost their health insurance. Just because the wealthy are doing well does not mean the economy is doing well.
That all said, I'm very optimistic for FX-322 and personally believe we'll see it by 2022. That doesn't mean COVID-19 wasn't very unhelpful in this process and nothing I said was BS. I agree though that help is on the way!
- Jun 15, 2019
- 157
- Tinnitus Since
- May 2019
- Cause of Tinnitus
- Likely infection/ear stress after walking pneumonia
Just jumping in here quick before I get to the end of the thread--in the U.S. it's very unusual for health insurance to cover all the cost of a hearing aid (the high end of standard aids can go up to $7000) and many plans don't cover it even partially. My own good plan covers up to $2000 or so every three years.
As for the drug-in-10-years discussion, I'm with those who say that's being super conservative and I'm confident that barring any surprises it'll be available in at least half that time. But I *totally* understand and share the frustration and dread attached to this subject.
Please don't make these kinds of statements.
First of all, there is no single COVID-19 vaccine, dozens are being tested. I also don't think I need to explain the difference between a pandemic and tinnitus.
Vaccines and FX-322 are currently in clinical trials. Phase 1 results were positive but that's not enough.
I know it's hard, really, but be patient. We don't want an accident with FX-322 delaying it for years.
The only thing that matters as far as COVID-19 vaccine vs. FX-322 are regulatory procedures. If the powers that be think COVID-19 is a more pressing problem (and it is) then they will cut corners and get something out faster. See an extreme case with Russia's "Sputnik" vaccine. It's unrealistic to expect them to handle FX-322 the same way they handle COVID-19.
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