Memberdude, this drug is been proven safe per phase 1. We should be pushing for this to be easily accessible for T sufferers. Your pushback really makes me wonder about conspiracy theories.
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get onboard with the activism bruh. you already agree that NIHL causes T. wtf homeboy??
They are currently safety testing FX 322 with 24 people. Am I missing something? Phase IIa is where the real clinical data will come in, until then, this drug is unproven and is more likely to fail than succeed. I hope it doesn't, but I'm trying to give you a reality check here. You're talking like it's already clinically proven and ready to be rolled out. Be patient and see how it unfolds (will take a few years).
As far as advocacy goes, I have no idea what your goal is? What are you trying to achieve? I literally can't figure out what you want people to do and I'm all for proactiveness.
If you could explain what it is you're trying to do it would help a lot.
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
Can't argue with that. Poor poor Danny. He went through years of total shit in what should of been the best years of his life.
Have you even read my posts?
They are giving the actual drug. Do you honestly believe that just because the official endpoint of the trial is safety that the subjects wont report IF IT WORKS?
They are going to know if it works by the end of this trial. Think about it. And if it is safe, which the first trial already showed, and they seemed to suggest that to @Deathtotinni down at the clinic.
My idea is that, if it is safe, and IF IF IF IF IF IF it works, which they will definitely know by the end of this trial then they should be allowed to hurry up and expedite the release of this drug. There is no good reason whatsoever why it should take years like you say.
I have clearly defined what we need to do so if you're still unsure the here.
1. They will know if it is safe and if it works by the end of December
2. We need a rep from the ATA to reach out to FrequencyTX to find this out
3. We need to then turn to the FDA to ask them to cut the red tape and approve it ASAP.
And your assertion that it probably wont work is based off what? The failed keyzilen trial? This drug is absolutely nothing like keyzilen, and this technology works in living mice, so you're wrong, it has a better chance of succeeding than failing.
FounderNot arguing with that, me having spoken with him personally as well, but it's worth noting that there is no conclusive evidence of him taking his own life.
The initial coroner report found cause of death as inconclusive. They are carrying out more tests as we speak and we should know more any week now.
Had it been self-harm, finding the cause of death would likely not be this difficult.
John, I love your passion, but it's clear you have no idea how drug development works. It takes over 10 years on average to get new drugs out into the public, and Frequency have literally just started. They haven't even completed any efficacy trials yet, so until this happens, nobody knows if this drug will work or not, including Frequency.
You will not get much data from 24 people. This phase is primarily to test the safety profile of the drug.
It's based off the facts. The percentage of experimental drugs that get past phase II (or IIa) is around 30%.
It's a long road ahead and they will need to gradually roll this out onto larger sample sizes. By December they will know if they can continue to phase IIa or not.
Again, I love your enthusiasm and I'm not trying to piss on your parade, but you have to be realistic.
Its clear you dont know how fast drugs CAN get to the market when the FDA cuts red tape!
Novartis' imatinib (Gleevec) for CML -- Phase 1 trials began in June 1998, drug was approved 3 years later in May 2001 (FDA granted fast track and priority review; FDA review was a record 2.5 months)
It's also clear that you dont understand logic.
IF they are giving the actual drug to patients with SNHL,
THEN IF IT WORKS they will know it, this year. FACT.
Do you seriously think they wont ask their subjects if the drug affected their hearing? Are you seriously right now?
John, it's apples and oranges. Imatinib is a cancer drug and would have been fast-tracked due to the fact that cancer kills people. I don't make the rules, but a drug for hearingloss restoration will not be given the same treatment.
Me: we should get our advocates to plead to the FDA to fast track a drug that may help us.
My detractors: no we shouldnt because the FDA process takes a long time.
Me: they are testing the drug in human patients right now and they will know if it works soon.
My detractors: no they wont because this is a safety trial.
My mind is blown.
My detractors: no we shouldnt because the FDA process takes a long time.
Me: they are testing the drug in human patients right now and they will know if it works soon.
My detractors: no they wont because this is a safety trial.
My mind is blown.
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
Sadly true. There is zero urgency to cure T. It's a non issue for 99% of the population......myself not included.
Yeah and this liar at the ATA said she would watch the Will McLean presentation and email me by the end of the week and let me know what she thought about it. We are totally on our own. People on this forum are beyond apathetic to their own suffering as well. I genuinely wonder if some of these people arent really just trolls keeping us subdued. If you really had tinnitus wouldnt you want to get fx322 out as fast as possible and do whatever it takes within your ability to advocate this?
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
In fairness to @Ed209 i suspect that he would be the most vocal of all (except you John) if any drug was proven to work in getting it to the most needy and desperate of us as quickly as possible.
But we do really need to get some proof of efficacy on something before we start demanding it as we'll have major egg on face if we raise hell for some drug that doesn't do jack shit for our plight. And perhaps hinder future efforts to get hold of something that does actually work.
@JohnAdams I'd like to apologize for being rude to you, I'm guilty of the same thing.
You are just a bit too presumptuous about Frequency Therapeutics, I do believe treating hearing loss should treat tinnitus but we don't know for a fact Frequency will succeed or how well it will work, the 2A trial in later 2019 will give us the answers to our burning questions.
I get anxiety about it as well but I can't predict the future and claim it's a cure guaranteed to work!
You are just a bit too presumptuous about Frequency Therapeutics, I do believe treating hearing loss should treat tinnitus but we don't know for a fact Frequency will succeed or how well it will work, the 2A trial in later 2019 will give us the answers to our burning questions.
I get anxiety about it as well but I can't predict the future and claim it's a cure guaranteed to work!
If it were this easy, John, I'd have flown over there myself and brokered a deal for a few cases of this stuff, and I'd be handing it out to everyone.
Unfortunately, back in reality we still have no idea about it's safety profile; we have no idea if it works for Tinnitus or Hyperacusis (noxacusis), and we have idea if it works for hearing loss. For all we know, there might be a side effect that increases tinnitus or hyperacusis, or some other unpleasant side effect that renders it unusable.
I'd already be singing from the rooftops if there was good data that suggested FX322 could help tinnitus/hyperacusis sufferers. A trial of 24 people (I think 8 or maybe 12 who will actually take the drug) will not tell us this, and it will take a few years to find out.
Will they even be looking for people with tinnitus and/or hyperacusis to see how well it performs for this purpose? We may only see secondary data that alludes to a possible effect unless they plan on testing it's efficacy for tinnitus? I haven't seen anything mentioned. Does anybody know?
They're going to know in December. All they have to do is give audiograms to the 16 that got the drug. Theres your efficacy data. I'm sure they're going to do that anyway. But then the FDA is going to make them do an official efficacy trial, which is bullshit.
I think I am being dreadfully misunderstood. I'm not claiming it will work. I'm saying
they will know in December.
Ok, I'll give you a hypothetical situation. Let's say in December that 4 people's audiograms improve (that's if they release this kind of data in December). What would you take from this? How will you interpret what FX322 will do for tinnitus from that?
It also depends by what margin someone's audiogram improves as they aren't exactly the greatest for taking accurate measurements in the first place. I'd say anything that shows a gain greater than 15dB on multiple frequencies would be quite promising. It may be that the people who are doing the safety phase don't respond as well as others do when they trial it across 1000 people or so, and they will also have a chance to study different dosages (if it gets that far). All this takes years to accomplish.
A lot of questions need to be answered at this stage. All I'm saying is to not get carried away. We saw all this hype with AM-101 and AUT00063 and both showed no clinical efficacy after years of work. At the time people were convinced they would work and would save everyone who is suffering from tinnitus.
wow guys I think I have finally, after years of searching, found a true cure for this.
https://www.amazon.com/Tonaki-Tinni...-fkmrnull&tag=googhydr-20&ref=sr_1_fkmrnull_1
https://www.amazon.com/Tonaki-Tinni...-fkmrnull&tag=googhydr-20&ref=sr_1_fkmrnull_1
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
@Contrast thoroughly exposed this scam. If the ATA werent useless they would be warning sufferers against this stuff. They suck. I talked to a woman with the ATA last week and she didnt know about fx322, then claimed they keep a close eye on research, but was seemingly offended when I pointed out that she wasnt up on research because I had to tell her about fx322. These people are completely useless. Completely. Just like the rest of the human race.
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
Don't despair John. I admire your tenacity and I know you genuinely want to help others and move the whole shit show on from the same old same old. Stay strong my friend and who knows one day you may be proved right.
MPP needs to have a gameplan, and I don't think advocating frequency in an early stage is a good start.
Wait till a successful stage 2 trial.
Right now let's just focus on stripping Jastreboff of his credibility, we need to let the ATA/BTA know he sucks.
Wait till a successful stage 2 trial.
Right now let's just focus on stripping Jastreboff of his credibility, we need to let the ATA/BTA know he sucks.
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
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