- Jun 18, 2019
- 294
- Tinnitus Since
- 05/24/2019
- Cause of Tinnitus
- Chronic headphones use and acute noise induced trauma.
I haven't seen any of the initial trial outcomes for this drug. Is this even successful at all?Stick around for SPI-1005.
I haven't seen any of the initial trial outcomes for this drug. Is this even successful at all?Stick around for SPI-1005.
I completely understand. There was a lot at stake.In that case, it could be a misunderstanding. I thought by ever, he meant of the main people deep diving recently, which is true. We were doing all sorts of analysis and looking at the pharmacology graphs, the statistics, the preclinicals, etc. I don't think anyone who deep dived expected a miracle. I would even go as far as say that no changes for multiple doses was something people were prepared for.
I don't think most people expected this. If they did, they wouldn't have invested on their own free will.
Pretty much. 4/15 responders on audiogram at 8 kHz isn't anything to write home about, neither is 6/15 responders on WR score.Do you mean to say the bear thesis was born out of group data?
Yes, it lowered tinnitus in Meniere's patients.I haven't seen any of the initial trial outcomes for this drug. Is this even successful at all?
If we're doing play by play as a form of therapy, I'll add lol. I'm speaking for my own opinions only.Pretty much. 4/15 responders on audiogram at 8 kHz isn't anything to write home about, neither is 6/15 responders on WR score.
I can't reconcile this though. Abysmal word scores were not a requirement for Phase 1, so why would people lie?If we're doing play by play as a form of therapy, I'll add lol. I'm speaking for my own opinions only.
Obviously, I saw the 4/15 and 6/15 numbers. What I just couldn't shake, really at all, was the insane unlikelihood of seeing those huge WR responders. I still can't. Then there was the fact that the <= 90% word ceiling reduced the WR to 4/6. Of the 2/6 non-WR responders, 1 was close and the other wasn't, but they just happened to be the person in the group with the shortest duration. For the same criteria, the placebos looked exactly like placebo data: 2 insignificant improvements and 2 insignificant decreases.
Really, my bull thesis was three fold, and I almost worked under the assumption that I didn't care about multiple dosing.
1) Placebos cannot improve in WR to the level that we saw from a few people in Phase 1. I didn't consider that someone could start low from a bias to get in. Never crossed my mind.
2) Recruiters would be close enough to the hardcore responders that even though the data wouldn't be perfect, obvious group level improvements would occur. Conservatively, the results for 1x, 2x, 4x combined vs placebo would be plenty strong enough so that even if statistically significant stratification didn't occur, we would all take a deep breath and see amazing >= 1 dose results.
3) Even if we say the 4/15 >10 dB improvement at 8 kHz compared to 0/8 for placebo isn't statistically significant (it wasn't, but the p-value wasn't too bad), surely the EHF would make it based on the pharmacology study.
Really, I was the most wrong about 1) and 3) and we don't know about 2). What we do know about 2) is that even if they applied a filter and theoretically had a good, quadruple blinded process, there's just rough, unforeseen issues with study design.
I am shocked that all 3 of my thesis points were destroyed.
Other way around. Lower are deeper.Also, aren't the higher frequencies deeper inside the cochlea, which they are currently having issues getting the drug to?
You make a fair point. The WR data from Phase 1 looked like about what you would expect.I can't reconcile this though. Abysmal word scores were not a requirement for Phase 1, so why would people lie?
It makes sense to do it for Phase 2 (it's shitty but it makes sense) but not Phase 1.
Could be synapses.How is it even possible to have better word scores and no improvement in the extended audiogram? That's like having no increase in strength, but being able to lift heavier objects anyway.
If you're younger than 75, don't do it. I've been dealing with this shit for 20 years now, and for every worsening that I didn't think I could bounce back from, I did. It has sometimes taken months, and for others years, but you will wake up one day and go "huh, I actually didn't think about my tinnitus almost all day today".FX-322 was my only hope. I have waited over 2 years, tortured to no end by tinnitus, only to learn this drug doesn't do anything or work at all, with no proper candidate to alleviate my suffering anytime soon.
I will now start putting my things in order and put an end to my suffering. It is sad it has come to this but I can't live like this.
I have heard Pegasos does accept tinnitus sufferers as potential candidates.
Please share the screenshots of your friend that had his/her tinnitus improve.So did anyone find out what's next?
They'll do the seven month read out next quarter, then the read out of the two remaining Phase 1/2 trials (age related hearing loss and severe hearing loss). What's next is anyone's guess. I won't be surprised if they go back to the drawing board.So did anyone find out what's next?
Maybe for you. It doesn't mean it's the same for everybody else. For me it simply is not doable.If you're younger than 75, don't do it. I've been dealing with this shit for 20 years now, and for every worsening that I didn't think I could bounce back from, I did. It has sometimes taken months, and for others years, but you will wake up one day and go "huh, I actually didn't think about my tinnitus almost all day today".
And my tinnitus is constantly about a 7/10 on good days, and hyperacusis is 6/10 on good days. Both are 10/10 on bad days. It's still doable.
I actually fear I might have been unknowingly complicit in the whole fraud thing, if that turns out to be truly legitimate. Most people were not given the reason for their rejection from the Phase 2a trial, but I was.I can't reconcile this though. Abysmal word scores were not a requirement for Phase 1, so why would people lie?
It makes sense to do it for Phase 2 (it's shitty but it makes sense) but not Phase 1.
It's either the unblinded individual data in Phase 2 will look a lot better (and they can compare long term medical records to see who was lying about word scores in Phase 2) for certain individuals or the patients in Phase 1 *were* somehow literally plants like Toby said but I don't see how that could have managed that without bribing testing centers and don't believe Frequency Therapeutics is a fraudulent company given the reputations of the people involved.You make a fair point. The WR data from Phase 1 looked like about what you would expect.
I'm not going to point fingers here, nor do I hold a grudge. The people who suck are those who went and purposely deflated their baseline scores. You weren't to know that.I actually fear I might have been unknowingly complicit in the whole fraud thing, if that turns out to be truly legitimate. Most people were not given the reason for their rejection from the Phase 2a trial, but I was.
They point blank told me that although my audiogram qualified me, my WR scores did not, and I shared that here on the forums... my intention was to save people the hassle, money, and mental stamina of getting a HF audiogram if they (like me) had no WR issues. Because it ultimately wouldn't matter even if you had measurable notches.
But now I see why most testing sites would not disclose the reason why people were rejected... because if you knew that the WR scores were the lynch pin you could more easily lie your way into the trial.
God I feel like I really fucked up.
There is much that happened. They found out from the second Phase 1/2 study (published today) that improvements in extended high frequency scores are absent in patients that improved their word scores. This drug doesn't do anything for the audiogram. And even in the patients that do improve (around 30% of patients), it's only around a 10% increase in word recognition.They have people from one shot studies that have improved. Why wouldn't they give those people another shot to see if they get further improvement? Does everything have to happen inside the study? Can't they help designing the study by doing some experimenting on side?
Unless one shot studies were fraud which I don't believe, than FX-322 still works but as the latest study showed, four weekly consecutive shots don't work. There was just an expectation that more shots would work better than one. As they said there was no way for them to test multiple shots on animals so they did on humans and it didn't work out.
Other than craze around stocks, there isn't really much that happened. They just need to refocus to one shot or multiple shots over longer period of time.
No chance of day 210 analysis being fundamentally different, in my opinion.I'm beginning to wonder whether a positive 210 day readout is possible. We don't actually need to see anyone in the treatment group improve further. We just need to see the placebo group go back to where the fuck they should be - baseline. But apparently that baseline was inflated due to trial design. Is there any universe in which the placebo group don't do as well second time round? I guess not if they're being "normal", right?
It's a tough spot and certainly not your fault.I actually fear I might have been unknowingly complicit in the whole fraud thing, if that turns out to be truly legitimate. Most people were not given the reason for their rejection from the Phase 2a trial, but I was.
They point blank told me that although my audiogram qualified me, my WR scores did not, and I shared that here on the forums... my intention was to save people the hassle, money, and mental stamina of getting a HF audiogram if they (like me) had no WR issues. Because it ultimately wouldn't matter even if you had measurable notches.
But now I see why most testing sites would not disclose the reason why people were rejected... because if you knew that the WR scores were the lynch pin you could more easily lie your way into the trial.
God I feel like I really fucked up.
I remember when I was a kid hearing medical professionals warning us about protecting our ears. When we were getting one of those required hearing tests at school, one of them warned that anything close to a cure for hearing loss won't be seen in our lifetimes or even in our grandkids' lifetimes and that hearing aids would be the only treatment.Does anyone else figure this thread will sizzle out and die like the Lenire and Audion Therapeutics ones if day 210 results are just as bad? The only drugs I remain hopeful for are Ebselen and the reformulated Trobalt.
Now I understand why veterans are so jaded towards miracle cures. It just doesn't work like that.