If it works I'm definetly flying. Not going to wait any longer than necessary with this horrendous tinnitus. And if the doses need be done in a period of 4 weeks, I will stay as long as needed and possible.
I talked to an audiologist about FX-322 phase 1 results and she said the word score results were "completely unheard of" and "remarkable." I think you are really downplaying what they were able to achieve with a single shot of their phase 1 dosing (which is less than phase 2 per shot).
So you're saying that all the people who received the placebo had these issues, and the ones who got the real dose didn't?
Interesting. It is quite counter-intuitive. In my experience, when one perceives sounds in frequencies that are normal, healthy, and specially in the lower range, the sound is perceived quite balanced. With mild hearing loss in high frequencies (20 - 30 dB) the sound is perceived enhanced once the sound hits that frequency above the hearing threshold. This is maybe due to recruitment.
It's too bad Frequency took down the presentations because they took a phrase ("Oh say can you see") and broke it down by frequency and you can see some parts had quite a lot of speech information extend into the ultra high frequencies even if the bulk of that information was lower.
Sorry I meant the audio that went with the slides but yes, you are right, the slides should still show that without the commentary.
That's what statistical tests are for. To sort out what's significant and what's random.
It's all in here. We still don't know what happened to him as his family decided to keep it private.
Thanks. Just double checking and making sure I understood correctly what that part meant.
This sounds like they are definitely planning a phase 2b and 3 then because Astellas has agreed to pay them for it, no? Or am I reading too much into it?
No mention of Canadian trials? Or would that be included in further trials with the U.S.?
It is certainly possible that EMA (Europe's FDA) could grant a ''prime'' (breakthrough therapy status) if it is proven that the medicine has proven to make a complete difference for patients in a clinical trial elsewhere, such as the US.
Sounds like a great plan @BBakkers. ! I will hold you to that. Maybe if we can go over there with a larger group of tinnitus suffering Dutchies, we could get a group discount at the local clinic. Two ears for the price of one perhaps
You may be in luck @hans799, because Astellas also has facilities in Budapest. I really do hope for you that they also decide to start trials in your country.
I think, based on the Frequency Therapeutics presentation, they will get money if Astellas' clinical trials in Europe and Asia for Phase 2b and Phase 3 are successful. That's how I interpreted it as.
I work in a noisy place where I have to understand sounds that totally overlap or partially overlap, so basically this is like a daily speech in noise test. I have also been submitted to speech in noise tests at several different ENTs. The performance can vary from one day to another for no reason we know. It is just like some days your ears interpret sound better depending on many things, like how you slept, if you are a morning person and the test is in the morning, and many small variables. Sometimes one hears loud but not very clear and suddenly words sound clearer, this just happens for no reason.
Sorry, but that's not improbable, it is just the most common thing, and can tell you first hand after 10 years of hearing tests. It happens all the time with audiometric tests, even the ones performed with the same audiometer. There are usually slight differences in hearing performance, and 10 dB is a very small difference, particularly in a high frequency.
Nope, I think there's just one authority for the entire EU, called the EMA. So it's just one process, not 27.
Sounds like a plan. I was already planning to do some when the time comes. I know a few people with some bad tinnitus, so we should be good for that group discount. Haha.Sounds like a great plan @BBakkers. ! I will hold you to that. Maybe if we can go over there with a larger group of tinnitus suffering Dutchies, we could get a group discount at the local clinic. Two ears for the price of one perhaps
But I am really thinking about partaking into the trial at Astellas (if they decide to continue trial 2B and 3). They have facilities in many European countries. Leiden (Leyden) also has one. So there's the possibility that they start a trail there. If you're from the other part of the country, you can also rest at my place in The Hague if you're also interested.
. Don't want to spam this thread too much.
Does that mean I can get the treatment in Europe rather than the United States? May be my home country, the UK?
I also found it confusing as well. From what the presentation stated I assume it may be possible for the EU and Asia to skip the earlier trials and start from Phase 2b since they would have data from the previous trials in the US.
That makes sense, and I hope it's correct.
Probably next important date is October this year. Then we know if this drug can lower tinnitus. If this turns out to be the case and they have optimised their dosing they may be open up for compassionate use as FGG said. So you may get your shot earlier. What I find a bit unfortunate is that they have not listed hyperacusis as an outcome measure of the trial. But probably out of 96 participants with hearing loss it is quite unlikely that someone has hyperacusis.
I think that Astellas and Frequency would be happy to save that money and go right to market (they won't turn a profit until then). They need a plan to make it through the full regulatory process, banking on breakthrough status would be poor form.
Member
