Skip to content
HearingTracker
Log in

FDA Grants Hearing Loss Drug, FX-322, Fast Track Designation

This topic is closed.

31 replies2.6k viewsLast reply

Jump
Link to this topic

In reply to @codergeek2015

@codergeek2015 said:

No email answers to a detail request is usually a bad sign.

I know some people over at the tinnitus forums got replies- even from Jeffrey Karp himself no less. I don’t think they have the staff to answer every email. Many questions they don’t have the answers to because they’re still trying to find the answers.

If there are no real risks in testing the drug, why not fast track it? Even if it proves lackluster, things will be learned and no one gets hurt but investors. And that comes with the territory.

It is being fast tracked. People do get hurt though, just not in obvious ways. This drug was hyped from day 1 and large numbers of people with severe tinnitus pinned their hopes on it. The hype worked. The founders of FX got very rich- or even richer than they were before. The bad news is that when the multi-dose phase 2 trial crashed, those who were heavily invested in it emotionally took a major psychological hit. Some of them took a financial hit as well because they invested to try to support the company. Source: hundreds of pages on TinnitusTalk forum, watching it all unfold.

In reply to @d_Wooluf

Of course I’m sympathetic to those who got their hopes up. I’m also a bit…cynical perhaps…about people who uncritically believe the stories told by those with a product or project to sell. The drug was untested. The promises were aspirational. both of those things should alert folks to have hope but not believe a cure is at hand. Hasn’t everyone seen this story a hundred times before? Bitcoin comes to mind. As far as investment money: it happens, a lot, that new research doesn’t pan out, even though it seems promising. Look at fusion power. Scientists continue with it and make slow progress. I wouldn’t invest in it quite yet.

In reply to @d_Wooluf

Let me blunt, exactly, if you really want to really fix your hearing, you need replace with with a stable system that can send electrical impulses such as a cochlear implant. The brain does not care and it is a bunch of data cable connected to the brain, your brain can recognize patterns based on your childhood memory…

In reply to @jeffrey

@jeffrey said:

I’m sympathetic to those who got their hopes up. I’m also a bit…cynical perhaps

You’re right. I got my hopes up a little and I was disappointed a little. But there are people out there living on the ragged edge in tinnitus land who bought into it totally. There are dozens of biotechs out there beavering away that you never hear of. They do the science and they either succeed or (mostly) fail. FX led with a story that was coherent and apparently plausible and they used the prestige of their Harvard labs to sell it. They didn’t just have promising new lines of enquiry, they had the answer! Borderline ethics in my opinion.

I have tinnitus too, and have had for many decades. Not as bad as many, which is a blessing. I’d love to see a cure, or even some amelioration. But all my life I’ve only heard that tinnitus is intractable and non curable. Period. So, it would take a lot to get my hopes up. I’m not familiar with FX; sounds like they engaged in border line ethics at least, as you write. Another biotech start up exec was recently sentenced to prison for lying to investors about their product. One hopes this will serve notice.

Not just fx-322 but their whole hearing regeneration program. Lots of drugs fail, but I’ve never seen anything hyped like Frequency Therapeutics. Sad and a little bit angry tbh. I think these guys should take a long hard look at themselves.

Money has been made. Reputations have been lost. We might see lawyers picking over the carcase pretty soon.

Related discussions