Recent content by John Queen

I can't think of a time frame till it will be available, but with all the recent developments (the partnership with Astellas, FDA Fast Track, new drugs legislation both in US and Japan etc.), I hope not too late. My guess is: around 2 years from now if everything works fine in the trials. But I...

... I bet they'll just recycle some gamma-secretase inhibitor, nothing new. But if they eventually come up with a new idea, well, that'd be great.

Please note that also: the patients in the placebo group had no clinically meaningful improvement whatsoever; the tests were the same. If there was some variation due to memorization or some other factor, I think the results from the placebo group would reflect it. many patients only had mild...

Thank heavens for this. I sent a mail to the FDA last year in which I tried to argue in favor of such a classification, giving examples of how people committed suicide due to conditions that aren't deadly themselves, but significantly alter quality of life. This is a sign that it might get...

Dude, there were 4 patients with +100% (yeah, doubled) word recognition scores. That result simply cannot be due to blind chance. Most of the other treated patients had only mild hearing loss and there was little room for improvement, as someone from Frequency reported. (Moreover, researchers...

“The Japanese want to be the regenerative medicine center of the world” -- that sounds good. Long live the emperor! :rockingbanana: Also, a highlight from the article: The “regen” boom in Japan is based on a series of reforms and new laws for pharmaceuticals, but especially the landmark...

Yes, that's correct. At least, that's what should happen; initially they announced the results will be published on 31/01/2020, but changed that recently, maybe something interesting happened and they need more time to analyze the data.

"A Phase 1b/2a study of PIPE-505 in SNHL is expected to begin in 4Q 2019, with topline results expected in late 2020." Nice, nice. So, by the end of 2020 we should have results from both FX-322 and PIPE-505 trials.

No problem, I'd be happy to try the dose used in the Phase 1/2 study, which is likely safe; I don't necessarily need good efficacy. Now I see... I honestly hope that'll change after this clinical trial. :( Even if they'd ask for a higher price for the drug to cover all the expenses, I wouldn't...

Those of you who are Americans, couldn't you petition to the FDA and engage the Hearing Loss / Tinnitus associations to find a way to include drugs like FX-322 in the expanded access program? It's plain stupid what the FDA does right now, FX-322 actually completed 2 studies (Phase 1 & Phase...

It would work for sensorineural hearing loss, but there are other companies which are developing treatments for genetic hearing loss, if that's the cause.

Woops, you're right. I've got some wrong info. It might be that he's actually McLean.

Awesome invention, looks like we're on the right track... that would mean they will be able to inject the drugs directly in the cochlea, like in an intralabyrinthine injection procedure, which currently is a very hard procedure to do. And oh, the perforation completely heals in one week, that's...

That guy on Reddit (Leviathan or whatever his username was) is not Will McLean, it's a postdoc researcher who worked in Frequency's team.

No, it didn't fail. They just narrowed (or changed) the indications and are continuing the approval process. This is a quite recent video that the company posted.