You can book the ticket now then. Big question is regarding efficacy though.
That's a long time for a drug that's going to be in phase 2 in a couple of months. 5 years is even high. Drugs that move quickly it's normally a 5-year thing if they have a new phase of the study every 18 months. Their first in human study was less than a year ago I believe and they are already on a 1.5 phase and planning phase 2. This is moving really fast. All the other drugs I'm waiting come out haven't had clinical data posted in 2-3 years which is normal. This drug has the potential to cure other things other than hearing loss. This is barely a drug and basically just a jump start to a normal biological function. Almost every drug that's ever been produced had a side effect and this one has not... because it's not really a drug.
Lol I've been saying this and literally just wrote it. People are loooking up the wrong statistics, Frequency Therapeutics is rolling through the clinical phases. The drug is going to cure a lot of other illnesses. This guy's thinking 5-10 years for the drug to come out and I'm thinking the company will have changed its name entirely by then to Immortal Therapeutics.
It sounds very optimistic. I hope you're right.
The hearing loss cure legitimizes curing hair loss which is going to make them billions on top of the billions they make from hearing loss. Have you not watched the videos where they talk about all the applications they are researching? They made it sound like they are testing the drug on a few diseases. It's a pretty easy concept to understand. They have a stem cell/progenitors cell activator.What an exciting time to be a bald man with hearing loss and tinnitus
Those drugs that cause long term side effects are from chronic use. This drug leaves the body in a couple of days. Now Decibel's gene therapy is different because that's going to permanently change you... not something I'm interested in. Frequency's just emulates what happens when you're in the womb and leaves the body in a couple of days. They also don't keep track of the study participants after the study is over. They would just have a longer study. It's just not how it works. Once the study is over they don't really care or keep track of you. But just because you are no longer getting dosed doesn't mean the study is over. A study could last a year or more but it doesn't sound like that's something they're going to do. Most of the time they do that to monitor people that have diseases that are chronic and can kill you. I worked at Parexel for a year when I first got out of college... I know how this stuff works bud.
It's worked on mice and regrown hair cells in human donated hair cells. They know it restored hearing in the mice because they responded to sound when before they didn't. You haven't read if it works on humans because the information hasn't been posted yet and won't till the start of next year. So maybe December, January, February.
The large scale trials don't start till phase 2-3. They have a process to this and if you're curious about it you should read up on the criteria for the different phases. 1. Safety 2. Efficiency 3. Large scale efficiency. And that's it and the drug goes to the FDA. The FDA approval isn't what takes time, it's the the time it takes to study the effects of the drug and by the way they are pumping out studies, the drug will be out in 3-5 years depending on how long it's at the FDA.
That's what they are literally testing right now. It functions in mice so the assumption is that it will work in humans. Why it was so important to John. He wanted to know so badly and he got a little carried away.
I realize safety and side effects may take years to determine but will we at least know soon whether or not FX-322 is growing cochlear hair cells in humans? Or will these results be kept private until much later?
We won't truly know the long-term effects of FX-322 until we have data that extends beyond phase III if it gets that far. It's interesting to note that tinnitus is listed as a treatment-emergent concern, and this is likely due to the delivery method.
Yeah the drug will already be out by then. You can't keep track of those people for 5 years after they've been given the drug. It doesn't happen in studies like this. They also don't study for long term effects bud. That's something that they figure out while the drugs been out. I think a lot of you guys are making false assumptions. And I think people are assuming this could possibly cause cancer.
Exactly. That's what I'm saying. Even when drugs are released to market, the risks and side-effects are still not fully understood. We can learn far more about the real-world effects of a drug when there is data covering a broad demographic. In fact, it's sometimes the case that drugs get pulled after release for precisely this reason.
I agree. Frequency Therapeutics will want to get this right and will not cut corners. We can only speculate about what the outcomes to the trials might be, but I am cautiously optimistic. If they can get fast-track status after phase II (if it gets to this stage) it could bring the timescale down to around five years or so.
That would be the best case scenario. But it means everything would have to happen in 1 year (2019) and by everything I mean phase 2 + phase 3 + paperwork. Hard to believe since phase 1 is still running and was started in 2016 (a year and a half ago).
I'm going to take a look at that project. Is there a thread on this forum to follow-up with this project?
The management of Tinnitus Talk will have a Q & A with Neuromod on 3 December. Today is the final day to submit questions.
I was thinking:
No you will know at the start of the new year. In just a couple of months we will know if it in fact works on humans. If it works on mice, maybe it'll work on my deaf dog lol
No this is something I believe would be covered by most insurance companies. I imagine it will be much cheaper than paying a couple thousand dollars for someone's hearing aid. Hearing loss is also more disabling than being a little near sighted.
It's simple math man. The rate at which they are having studies can predict when the drug will come out.
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