This is such great news. Id love to think that in 12-18 months we have at least a treatment or some kind of assurance we will all be saved one day. This is a great day.
I appreciate your summary here. I wonder if these sorts time scales would necessarily apply to a drug candidate such as FX-322, since it is not a systemic, regular or chronic use medication.
Awesome idea... everybody should do this... everybody on this forum.
If the linings in our stomach regenerate every 4 days, I wonder if this is something that can be used not only more than once, but maybe even on a long term basis. Maybe a shot a month for a year... to get your hearing back. I'm speculating too. Maybe a shot every few years to keep people at perfect hearing so that tinnitus goes away.
Thanks! My "analysis" was just a statistical estimation based on a median of wide variety of drugs approved and should be read only in that context. Key message is that a breakthrough designation speeds up the process by several years -> median to approval from 8 years to 4.8 years.
Interestingly, I have read researchers state that although drugs that regenerate hearing are readily available, the problem is getting them into the ear in sufficient quantity and long enough to take effect. No doubt this is the challenge for Frequency Therapeutics too!
From my experience, it takes months.
I think that what you have said here is exactly correct. It could even be a shot a week for several weeks or months.
I agreed with what you are saying, but they noted improved word scores... I'm guessing that has to be good for at least 10 to 20 dB improvement across the higher frequencies (2 kHz to 8 kHz and beyond...). Hopefully they concentrate on dosage and not schedule, because that could take a long time. It might also be different for different people. I'd be happy with a 15 dB on the first shot, then 10, then 5, then 2 etc etc. If it can take someone at close to CI level and take them back to hearing aides, that would be good enough for me.
You just don't understand clinical trials I don't think. They don't rush anything and they don't just go at it like amateurs. They review everything down to the tiniest detail so they can provide clear solid evidence. Stop being so negative about it, it takes time to go through the process and do it properly. They are not bothered about trying to sort it out as quickly as possible, they will sit around and talk about and plan the next move until the cows come home and move on from there. They are driving in the dark, trying to avoid the ditch at the side of the road and have a long and rocky journey ahead of them. Stepping on the gas peddle is just not how you do things if you want to be sure you get to your destination.
You think wrong.
Absolutely nothing about my comment was negative.
Right, that's why I said it may take a long time. It also unnecessarily takes more time because the FDA system is definitely broken.
Did you even read my comment? I said it may take a long time to get the dosing right. Frequency Therapeutics wants to move as quickly as they can, even if that means moving slowly.
Well, I think that if they don't realize that this is one of the most urgent medical needs in the world currently, and that it needs to be maximally sped up, than they are bunch of freaking retards. No need for petitions, there are hundreds of millions of people with hearing loss and if they don't realize that most of those people need a cure as soon as possible they should just straight up close FDA, it is a freaking useless organization and a drain in the budget.
And even if everything runs fast, I can imagine that marketing and pricing, deals with insurances will take additional time.
It's easy. The chemical diffuses through the round window of the cochlea and comes into contact with dormant stem cells. They wedge into notches on the outside of the cell called signalling pathways, this in turn starts a chain of events that prevents a compound called beta catenin from being destroyed. When enough beta catenin builds up inside the cell, it enters the nucleus. Once in the nucleus it triggers a process called proliferation which basically wakes it up and then through a process called paracrine, the stem cell morphs into a cell like the ones near it, which in this case are sensory hair cells.
That's very insulting towards the many high-ranking people in the FDA who have dedicated THEIR LIVES into the making of the FDA. Take David Kessler, for instance, former commissioner chief of the FDA. "It's the fastest and most efficient drug-review program in the world!" he said in 2017.
Dude, why don't you just go and straight up work for Frequency Therapeutics. You're living encyclopedia on the field
Maybe you're right, maybe not.
"I believe the clinical trial system is broken," said Janet Woodcock, who has worked at the agency for more than three decades, at an industry panel on Nov. 14. "I do not believe it serves the interests of patients."
It really did come across that way, I apologise as I was slightly irritable at the time and it was unjustified but really it was a fairly negative view point. They achieved exactly what they set out to do, it's safe and it works. Nothing to do with not getting good enough results and so they will test it with more doses. That's just not the case IMO.
My pending concerns are:
FX-322 causes the supporting cell to divide first.
I don't know, maybe someone else does.
I have sent my resume.Dude, why don't you just go and straight up work for Frequency Therapeutics. You're living encyclopedia on the field
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