MemberIn the dream scenario where FX-322 is successful and gets approval for compassionate use right after this Phase 2a, I wonder if people outside the US could also apply for it and then travel to the US to get it? Or do we need to wait for Astellas to get involved in other countries? I am from Italy by the way.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
- Apr 6, 2020
- 1,031
- Tinnitus Since
- 2016
- Cause of Tinnitus
- 2016: headphones, 2020: worsened thanks to Rammstein
Hi @Pharz.
Well, according to the procedures of the EMA (Europe's FDA), there are two conditions that need to be fulfilled in order to receive compassionate use:
The first condition concerns EMA (Europe's FDA): According to their guidelines, compassionate use is allowed if the treatment is in clinical test phase in Europe + that the said treatment has a chance to help a patient who has a debilitating or life threatening illness. So that may not be a big problem, as FX-322 will be tested in Europe in the nearby future and the big IF that results from Phase 2A point to tinnitus alleviation.
The second condition is Astellas (that has bought the license from Frequency Therapeutics for future commercialisation of FX-322 in Asia & Europe): are they willing to offer compassionate use to those who are in dire need of a fix? So basically, it's really up to them to fill in a request at the EMA for compassionate use if they want to help tinnitus sufferers.
- Aug 5, 2019
- 1,852
- Tinnitus Since
- 05/2019
- Cause of Tinnitus
- Autoimmune hyperacusis from Sjogren's Syndrome
I have never checked a forum thread this much for someone checking their email for a press release update from a certain company.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Is there a way to get email updates from Frequency Therapeutics? I know Otonomy's site has such a feature, but I haven't seen one on Frequency Therapeutics' site.
EDIT: Just found it, it's on the "Contact" page. Kind of an odd place, but cool that they have this feature!
In my opinion, there's no way results are out later than this Wednesday; due to the Future of Hearing Health Conference.
- Apr 23, 2019
- 364
- Tinnitus Since
- 04/2019
- Cause of Tinnitus
- Slap to the ear / Leading to more issues after ear surgery
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
- Aug 5, 2019
- 1,852
- Tinnitus Since
- 05/2019
- Cause of Tinnitus
- Autoimmune hyperacusis from Sjogren's Syndrome
I mostly agree with you. If they have been sitting there for a long time just waiting for the right time, it makes sense to release before the conference.
However, a lot of detail goes into these reports. It's really easy to catch something small. They are going to prioritize accuracy far more than making it by then.
I don't see it as some huge political hit if they don't have them out by then. Everyone knows that science is slow; I don't think anyone at the conference is going to think they are failing or something. Plus, their pre-clinicals and Phase 1 stuff is plenty strong enough for now.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
I partially wonder if they're waiting for top-line data from the Age-Related trial, which is set to close any day now... They filled that trial up in record time.
Is there an unwritten rule about releasing news on St. Paddy's day that I'm unaware of?
It is incredibly possible that they conduct the conference and talk about things such as actions and treatments generically or from a broad approach and don't actually discuss the treatment outcomes.
Either scenario is entirely plausible IMO.
- Aug 5, 2019
- 1,852
- Tinnitus Since
- 05/2019
- Cause of Tinnitus
- Autoimmune hyperacusis from Sjogren's Syndrome
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
AfroSnowman
Member
- Jul 23, 2019
- 1,075
- Tinnitus Since
- 04/2019
- Cause of Tinnitus
- Nonnatural energy source
It could also be released pre-market (i.e. before 9:30 am). The news for OTO-413 was released pre-market, at around 7 am.
I think most people expect it to be released either after hours tomorrow (after 4 pm) or pre-market Wednesday.
That's what I was going to say. The week we are probably getting the data also marks 500 pages of discussion.
Keith Handy
Member
- Jan 5, 2021
- 302
- Tinnitus Since
- 11/2020
- Cause of Tinnitus
- Stress + sleep deprivation + noise
If you turn out to be right, I'm going to try to commission a tarot reading...
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