Recent content by AtlasFainted

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. They will end up reformulating either way because the technology exists and multiple shots per ear is damn inconvenient for everyone. At that point...

@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 drug. The context being that the delivery vehicle to treat the entire cochlea exists (I think pipeline is using it?), but this technology is not used...

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. It was also Trump's head of the FDA that said last year that regulation reform is needed. Of course haven't seen any action taken to backup that...

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 some people have gone blind from LASIK; any procedure has a small amount of risk. Personally I would take the first of 4 injections of FX-322 in each ear...

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 isn't genuinely looking at Expanded Access after Carl LeBel just said on the Tinnitus Talk Podcast that it was something that they are "certainly...

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 safe place to: 1.) Criticize the FDA 2.) Propose better solutions I'll follow up with a post explaining my personal points of concern below.

Carl LeBel on Expanded Use during the Tinnitus Talk Podcast: "[...]firstly and importantly our position on expanded access is due to really the fact that we don’t fully feel that we’ve been able to characterise the safety profile of the drug yet. And so loosening the philosophy of sharing...

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 Expanded Access is going to depend on phase 2A results. To me this is great news. All we knew before was from Frequency's website, which stated they...

@MrCrybaby I remember you saying you had similar fullness/popping symptoms to me and attributed it to middle ear muscles spasming. You expressed that you think FX-322 might remedy this. I was wondering if you could provide any additional insights - mine constantly pop when I swallow or move my...

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 see what the problem is. You mention "druggies" exploiting legal drugs for recreational use. So the people these drugs can help shouldn't get to use...

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 what this drug is for...

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 each individual. For something like FX-322, this means Frequency would have to devote a lot of resources to this "red tape" alone. If new legislation...

There's actually legislation that says the FDA can't take what happens with Right To Try cases into consideration when considering a drug for approval - only the cases in actual clinical trials. Also one of the requirements for compassionate use is that you don't qualify for a trial. I suppose...