Ohh, so say something goes wrong with this next trial and it doesnt show efficiancy, could they tweak/fix it and then they would have to restart from the beginning again like preclinical rats--then to phase 1-2-3 again?
Autifony Therapeutics Phase I Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter Hudson
- Start date
MemberI have no idea about that
Guess it depends on what they decide - its not uncommon to give up after failures.
Ken219
Member
Lets get it to market!
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Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
- Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
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2015 sounds fantastic.
I would add that pressure from Dept of Veterinary Affairs will be enormous for early access.
12,000 million dollars spent on compensation since 2004.
2017 alone is estimated by congress to exceed 3,000 million dollars. Yes, staggering.
If Autifony delivers it will be rolled out at lightning speed.
Now would be the time to publicise this growing financial pressure for early access.
Anybody here good at PR?
So true. If this shows efficiancy in phase 2, the u.s government might try and get it earlier for veterans cause of the 1 billion dollars a year in dissability. And those veterans do complain alot and want a "cure" treatment or whatever, and for serving our country they should at least be able to do that for them if this "works" and does magic. Land of the free--- freeee the T!!!!!
That's Dept. of Veterans Affairs - not Veterinary. 
- unless cows also have their own tinnitus association.
- unless cows also have their own tinnitus association.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Autifony already has a PR agency in the UK - with a business/finance 'City of London' (equivalent of Wall Street) angle, ie targeting the money. I work in marketing/PR and I have no doubt that if this works it will gather momentum so fast it will barely need PR. It would be a PR's dream to work on
Update on Autifony site in case no one has yet seen it =
Tinnitus Study - Information
Autifony is sponsoring a Phase IIa clinical study, with the University of Nottingham (Prof. Deborah Hall) as lead academic collaborator. This "proof-of-concept" study will explore the potential of Autifony's lead Kv3 modulator, AUT00063, to reduce symptoms of tinnitus in people who have subjective tinnitus.
The study will be conducted at a number of sites across the UK and is anticipated to start in September this year. More details of these sites, information about how to enrol in the study, and study eligibility will be available via this web page towards the end of the summer.
Rhea x
Tinnitus Study - Information
Autifony is sponsoring a Phase IIa clinical study, with the University of Nottingham (Prof. Deborah Hall) as lead academic collaborator. This "proof-of-concept" study will explore the potential of Autifony's lead Kv3 modulator, AUT00063, to reduce symptoms of tinnitus in people who have subjective tinnitus.
The study will be conducted at a number of sites across the UK and is anticipated to start in September this year. More details of these sites, information about how to enrol in the study, and study eligibility will be available via this web page towards the end of the summer.
Rhea x
Ken219
Member
I guess stop giving your money to a government that doesn't do anything for the people?
Yess do it! You can come back here and tell us how your T is no more, or close to it
The day this happens, I will write "good bye T." with shots & then drink it.
FREE VOUCHER: to the first person who goes to the trial & comes here with good news, I pledge to send no matter where you are in the world the finest Maple Syrup I can find (I am from canada
)Please make me send this syrup
Isnt it for patients with tinnitus up to 1 year only? I think the subject was under discussion a few pages back.
This is the case for the AM 101 (for acute T.), not the AUT00063 I think (Chronic T.).
You profile tag...
Are Autifony using our TT forum profiles then to clarify our medical background?.... I think not
Yeah Hudson said that, but with no source to back it up and he didnt answer when people asked where he got that from so nobody knows if it's true.
Hopefully not. I don't understand why they would limit this in any trial? Wouldn't you want to try and cover as big of a range as possible in terms of everything from loudness, frequency, duration of T, etc, to pinpoint better how/when a method potentially works? I can see the reasoning behind maybe separating medicine-induced, decease-induce, noise-induced T etc, but within each category, why not make it as broad as possible?
Are Autifony using our TT forum profiles then to clarify our medical background?.... I think not
You evil, I like dat
I received that information from someone who went to see a neuro-otologist near Nottingham who was familiar with the trial. As always, it's hearsay but often times that's how we can find some of this information out.
In my experience study design are very likely to change, and I believe they might have updated it and I believe it would not make sense to limit chronic to less than a year -__-'
After the acute phase of Tinnitus that is now abitrary set at 3 months, I never read any scientific paper giving me evidence of time having an impact on T. (except that it reduces a bit because of brain plasiticity)
So it can be 3, 10, or 20 years, it should be the same I guess.
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