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Yeah this is what I mean. We should be focusing on initial approval regardless of whether the current combo reaches all the frequencies we want....
@FGG I think I remember talking to you several months ago about how it would take a year of trials to approve a reformulation of an FDA approved...
I hope Woodcock takes it then! Less regulation is better in my book.
Considering that it was Trump who opened up Compassionate Use, I doubt Biden's new FDA head will be willing to break down bloated FDA regulations....
I don't think it's very likely. Someone on Reddit talked once about how he'd had over 30 or so ear injections and was fine afterwards. I mean...
While I agree with this chain of thinking and have posted as much before, I think it takes a certain amount of cynicism to believe that Frequency...
Done: FDA Rage Thread Feel free to make a post there ha.
Hey all, I and others have grievances with the FDA. In an effort to keep other threads from going being derailed, I have created this thread as a...
Carl LeBel on Expanded Use during the Tinnitus Talk Podcast: "[...]firstly and importantly our position on expanded access is due to really the...
Something that I haven't seen mentioned here (but I may have missed it) from the Tinnitus Talk Podcast is that LeBel more or less confirmed that...
@MrCrybaby I remember you saying you had similar fullness/popping symptoms to me and attributed it to middle ear muscles spasming. You expressed...
Yeah, I think you and I have really different values here. As long as a company isn't selling straight up poison and calling it medicine, I don't...
This is interesting, I thought damaged cells almost always enter apoptosis. I'd say maybe they were referring to synapse damage, but that's not...
Are you familiar with what it takes to get a drug after a sponsor allows for expanded access? There's a lengthy paperwork process involved for...
