MemberI think the multiple doses statement could be a positive. If one dose gives you 10 dB, they probably want to see if 5 doses gives you 50 dB. I don't think there is any implication that a single dose won't do any good. The article also mentions the fast track so they must be onto something.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
I truly hope all that you have said is what happens, I know it's not for sure, but I hope something can help us out here. If not, I hope you see improvement with the injections you got and that may be our cure. I'm so sick of this chronic illness. I'm just tired...
https://www.wcvb.com/article/local-company-working-on-treatment-to-reverse-hearing-loss/26596728
Frequency Therapeutics's work mentioned by this news report. Things are looking pretty good!
Frequency Therapeutics's work mentioned by this news report. Things are looking pretty good!
Yeah, when they were testing gamma secretase inhibitors on rats, first they gave it to them orally before they tried eardrum injections. The rats regained their hearing but their hair fell out, their skin changed color, and they developed skin tumors. Messing with cell signaling in this manner is potentially very dangerous.
- Jan 25, 2013
- 3,573
- Tinnitus Since
- 2008
- Cause of Tinnitus
- TMJ disorder, airplane barotrauma, noise exposure.
Street Novelist
Member
- Apr 2, 2018
- 290
- Tinnitus Since
- February 2018
- Cause of Tinnitus
- Listening to loud music through headphones
richard.mitrano@frequencytx.com
He would probably know the answer as to when the next phase is beginning.
He would probably know the answer as to when the next phase is beginning.
I've had a CI for about 29 years so let me tell you it doesn't knock out the tinnitus at all. It might lessen it a bit but as far as eradicating tinnitus, no way! Constant hissing, humming for 38 years...
Ah ok, so there are some safety concerns even with injections at high doses after all?
The decibel scale doesn't work like that. For example, if one dose gives 10 dB improvement, a second dose would only amount to a 13 dB improvement, and 5x a little over 16 dB improvement. And that's only if the subsequent doses improved hearing by exactly the same amount as the first dose.
True, assuming a linear improvement. However, the effect might be exponential...
So you're saying that I can eat FX-322... Seems like a pretty small price to pay to get my hearing back and my tinnitus gone. No hair, I turn blue with skin tumors... hmmmmmm. I could start a new race of super beings. Maybe that's how we are all supposed to evolve...
Good points on the dB example I posted. Agreed with the guys who said that there would be diminishing returns. There is no good reason why it would be exponential, and linear like I mentioned doesn't make sense either.
Just an example:
Say it turns out you need the cochlea to be continuously exposed for 10 days for a hair cell to fully grow.
If an injection stays say two days in the cochlea, one injection would have zero effect as the hair cells would not develop within that time. Two injections would also have zero effect has well, but five would have "full effect".
(This example has no basis in any data posted by Frequency Therapeutics or other source)
I think once the cell is signaled the process just starts and finishes on its own. I really don't think it will need to to be continuously exposed while the hair cell grows to maturity.
This makes sense to me. As far as I know stem cells in the womb gets a command and then they fullfil it. It's not like someone needs to check in and refresh the memory of the cell about what it should become.
Coleoptere
Member
I'm curious what the impact of the Fast Track Status will actually mean for the availability of FX-322 in the market place. Any ideas? The FDA has 60 days to respond once Frequency Therapeutics has raised the request for getting that status. So that may explain the radio silence as we are in that 60 days time limit.
I'm pretty sure they want/need to conduct the phase 2 study (and phase 3?) before they ask for a fast-track?
I think there is no official word on when phase 2 will begin yet though, right? Or finish for that matter.
"Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition."
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
Deathtotinni
Member
- Dec 21, 2017
- 157
- Tinnitus Since
- 9/10/17
- Cause of Tinnitus
- Qtip and maybe a sound..who knows
Nice clip, thanks for posting! Fast tracking plans confirmed which is good. Does someone know why they would need to inject multiple doses? Not sure if it is a relevant question though.
How far is that ABC station broadcasted? Just 30 miles from Boston or does it cover all of New England?
Chestnut94
Member
Street Novelist
Member
- Apr 2, 2018
- 290
- Tinnitus Since
- February 2018
- Cause of Tinnitus
- Listening to loud music through headphones
Important news:
https://www.npr.org/sections/health...ioner-scott-gottlieb-announces-he-will-resign
Who ever the new FDA commissioner is could significantly affect the fast track status and when this could be approved.
https://www.npr.org/sections/health...ioner-scott-gottlieb-announces-he-will-resign
Who ever the new FDA commissioner is could significantly affect the fast track status and when this could be approved.
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