Separate names with a comma.
That was actually a typo and the post was outside the edit window by the time I noticed, so thanks for the opportunity to clarify: Meant to type...
Anyone else check out the post-hoc data Kil presented at the ARO meeting? I was very pleased to see the unexpected benefits with ARLH. Sounds like...
My estimate is 2027/2028. A 2029 estimate is likely too pessimistic given the FDA’s recent Breakthrough Therapy designation. The safety study is...
Sound Pharmaceuticals Receives FDA Breakthrough Therapy Designation for SPI-1005 to Treat Meniere’s Disease
"To those suffering ongoing sensorineural hearing loss" this exactly describes the majority of Meniere's patients.
I think we're a bit confused what you're pioneering as "new" here, as this has been preformed for more than 80 years [1].
My question as well is how this impacts the release timeline, if anyone has any information. I'm inferring the drug will not be released until...
They ran a randomized, double-blinded Phase 3 trial on SPI-1005. The co-primary endpoints were met beyond placebo, which is why the results were...
Okay, but again this could mean a lot of things. If tinnitus occurs as a result of ongoing fluctuations that SPI-1005 successfully mitigates, that...
First of all, what is the source for this? SPI-1005 is a preventative. It mimics and boosts glutathione peroxidase—that will reduce inflammation...
What made you think SPI-1005 might improve your tinnitus? SPI-1005 is not a cure for hearing loss. Its primary role is to help prevent or...
Ivan, this is great to hear! The big question - are you saying this recovery was spontaneous or was there a particular shift in treatment /...
Thanks for sharing your experience, but your comment leaves a lot of important questions unanswered. Meniere’s isn’t currently universally agreed...
CEO Jonathan Kil just updated via Linkedin 10 minutes ago: "We have already received fast track designation and will look to have an pre-NDA at...
June!! A veteran of this forum. You are still dealing with this? Have you found any new help since Dr. Derebery retired? It's intriguing to me how...
Great find. For those curious, here is a link to the study details. When CEO Jonathan Kil was asked in February about the drug's availability,...
Sound Pharma to Present SPI-1005 Preclinical and Clinical Hearing Loss and Tinnitus Data at the Defense Health Agency Hearing Center of Excellence...
What's the source on this? Do you mean spontaneous cessation of fluctuations, or burnout (which implies so much damage has been done that there's...
Ah, you're right. Here's the official announcement: Sound Pharma Announces Positive Phase 3 Results for the Treatment of Meniere’s Disease with...
Source?