She asked. She went on to say, "That was the question I asked myself before I set out on this project. I stand with you all here today, accepting this Nobel Prize, feeling deeply satisfied with the way that I answered this question." She then jubilantly exclaimed with all of her might, knowing that all cured hyperacusis patients in the audience would be just fine.
In the Phase 1/2 trial, they only tested standard audiogram ranges, WIN, and WR in terms of hearing. The reason why people are cautiously optimistic is because WR and WIN are believed to be signs of improvements in the extended high-frequency (EHF), where many people also believe high pitched tinnitus can occur.
It won't solve issues. They only used one dose and yes you're right, only 4 people saw those gains. If FX-322 doesn't show larger gains in the Phase 2 trial then it's potentially a flop. Maybe not but word scores mean shit in my opinion. People need real gains in the audiogram to show FX-322 will help.
It's extremely likely there were bigger changes than 10 dB above 8 kHz. Hence, the word score increases. We should understand the effects of multiple dosing better soon with the 90 day readout (before end of March).
These results came from a trial that was mainly testing safety with one shot. If one single shot had those kind of results, I think there's much to be optimistic about. In the current Phase 2, they are doing up to 4 shots. They know FX-322 works, it's just a matter of getting it to the areas that it needs to go to.
I hope they release the full pharmacokinetic Phase 2 multi dose data because it would be interesting to know if the proprietary molecule goes deep and VPA doesn't and if it would be worthwhile to take oral VPA (or injectable) at the same time.
This doesn't surprise me at all, as there have been hints from LeBel in his various talks about examining reformulation/redosing.
Until you have evidence and certifiable proof that you can make such claims about your treatment, you simply cannot. Consequently this is why people like LeBel are very conservative and measured with the things that they say about the medicine. Most likely this could lead to them getting in a spot of trouble with various regulators and would actually end up jeopardising their progress.
We shall see what happens. Could be nothing but a major disappointment. I think they will show something but who knows. They said Anna Nicole married for love but that was definitely a lie. Lol.
Your intuition leads you correctly here I believe. It really says more about the pathetic standard of testing than anything else. So many secrets of the ear to uncover.
I imagine American citizens are going to take precedence over foreigners. Maybe I'm wrong but I don't see why they would recruit elsewhere being millions here have hearing loss.
Well, medical doctors apparently (re)discovered the Riemann integral (or better, the trapezoidal rule) in 1994, lol.
There is a compound in Phase 2 being investigated for OCD, named BHV-4157 or something, using Glutamate regulation as opposed to the typical SSRIs. There hasn't been a new drug for OCD for over 20 years and the ones that exist have just a 60% chance of success.
There is a paragraph in at least one official document stating that there will be a payout from Astellas (a financier/partner of Frequency Therapeutics) once the first patient is dosed in a Phase 2 trial in Europe. So there is definitely incentives for it.
According to Frequency Therapeutics' annual filing with the SEC, part of their agreement with Astellas is to conduct an international Phase 3 that includes EU, Asia, etc.
This is low key gold. Talk about shitting on mathematicians. It's like a mathematician thinking they invented the concept of a positive ion because they subtracted a negative number once.
I think that FX-322 will help repair hair cells, and that hair cells are related to tinnitus, so by virtue of fixing something that is related to tinnitus, it might help tinnitus. But the "phantom limb of the ear" hypothesis is not really a unifying explanation of tinnitus, unless you acknowledge the non-trivial percentage of brains that are perfectly adapted to lack of auditory signal input.
No offense but do you have to be so angry all the time? It really doesn't help matters, believe me.
There is a great organization called One Health where vets and MDs get together to share their knowledge and advance medicine but it sounds like they need to invite mathematicians, biochemists, engineers and maybe even throw in a few ethnobotanists as well.
Cochlear implant surgery is extremely destructive to adjacent frequencies from where the implant is inserted. They can actually further cochlear damage. The implants themselves can bypass the damage with the signal by directly stimulating the neurons, however, current CIs are crude and don't cover very many frequencies relatively. I suspect this will be less of an issue with the optical based CIs they are working on because those can span frequencies more continuously.
Maybe a better counter-example is a standard case of presbycusis. I personally have known people with profound hearing loss without tinnitus. Or if they did have it, they never mentioned it. Don't get me wrong, I still think tinnitus is fundamentally an ear pathology and would like to see more otology-pipelines than hacky get-used-to-it-machines.
I'm going to stop commenting on this, but that paper makes me so mad. It's total ignorance over the most basic part of math. Literally, the objective of the paper is the "ingenuity" of regurgitating a simple idea taught to even high school calculus students! She even names it after herself! My god, that's so wrong. I'm pretty sure they even asked her about it and she dismissed Riemann's method like it was so obvious. Lol everything is obvious today. Many people today fully understand calculus through real analysis, but coming up with it is simply unbelievable.
This is my personal favorite published paper:
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