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No, it is not. Yes, I would definitely take it even if my tinnitus is not really bothersome (but I fucking hate it).

I don't remember the exact details as it has been 6-7 years. No side effects other than mild to major dizziness for 10-15 minutes here and there. I do remember a major dizziness episode where I briefly passed out; it was definitely scary, but that was it, and I can't really fully blame Trobalt...

Same. Trobalt did not provide any lasting reduction, but it definitely lowered my tinnitus, if not completely shut it down, for some hours.

Based on nothing because I tried Trobalt back in the day when I was already several years into my tinnitus and it worked like a charm.

Frequency Therapeutics Announces Topline Results for its Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss "FX-322-208 Study Fails to Meet Primary Endpoint, Showing No Significant Separation in Speech Perception Between FX-322 and Placebo Company Will Now Focus on...

Someone remind me of the next big date? I believe they are going to publish some important results in Q1 2023?

Anything else to contribute other than an ad hominem fallacy?

Answers below: There are never a "plenty of peer reviewers wanting to peer review." Actually, I don't think nobody would voluntarily peer review a paper. It is a very ungrateful activity where reviewers are not paid, but are imposed extremely tight deadlines and conditions. This is so stupid I...

I don't want to be rude, but as someone who has published papers, I can tell you that you have no idea what you are talking about.

I believe they said during the call that this trial was not enough for the FDA to go straight to market and that they would need to do another one.

Xenon Pharmaceuticals Announces Positive Topline Results from Phase 2b ‘X-TOLE’ Clinical Trial of XEN1101 for the Treatment of Focal Epilepsy Stock +80% as of now.

Frequency Therapeutics Announces New FX-322 Results Showing That Additional Study Participants Gain Hearing Improvements at Later Time Points LEXINGTON, Mass.--(BUSINESS WIRE)--Sep. 22, 2021-- Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on...

On a side note, this guy, Risitas, died a few weeks ago, unfortunately.

Still don't get why you all keep wasting so much time and energy with people who only contribute nonsense. Use the Ignore function.

Shots fired :whistle:

I would advise not to read too much into their tweets because they are most likely unrelated to clinical trial results. Just my opinion, though.

Next steps for FX-322: They insisted on the fact that Phase 2a trial design introduced bias, and that four successive injections didn't create the best environment in the inner ear for FX-322's regenerative properties. Future trials will be single-dose. This does not rule out the possibility...

FREQ's presentation at the 20th Annual Needham Virtual Healthcare Conference starts in 30 minutes. Live streaming is available here.

Frequency Therapeutics Expands its Clinical Development Team, Adding Expertise in Inner Ear Physiology and Translational Science Addition of Jeffery T. Lichtenhan, Ph.D., a leading expert in hearing diagnostics and measurement. Dr. Lichtenhan’s laboratory has aimed to develop novel, clinically...

Frequency Therapeutics to Present at the 20th Annual Needham Virtual Healthcare Conference

Full Phase 2a results are also coming at the end of June: "The Company plans to report final results of the Phase 2a study in late Q2 2021."

Not only that, but who knows what other inner ear regeneration may FX-322 trigger. I will gladly take only a 10% hearing improvement if it improves a 100% my tinnitus.

Same. I have about €5000 on FREQ stocks (my average is around €53 or so), haven't sold a single one after the Phase 2a flop, and thinking about adding some more.

Just don't feed the trolls. Use the Ignore function by clicking on his avatar.

I wonder why you keep wasting time with this Olive27 guy. His contributions are nonsense. Just use the Ignore function by clicking on his avatar.

Hence my fear that FX-322 will be discontinued if they can't "objectively" prove improvements in audiograms and/or EHF even if it does restore some inner ear structure that alleviates tinnitus, hyperacusis and whatnot. If FX-322 fails to restore hearing, I really hope they will repurpose the...

IMHO, Phase 2a failed, not the drug. It's too soon to say that.

As I stated in my previous message, this rating was prior to the PR release with Phase 2a results, so now it is pretty much useless. Oppenheimer, however, did issue a post-PR rating setting a price target of $20. Stock is at $8 or so, so I guess these guys still have some confidence in FX-322.

Check this one out.

Don't want to be mean, but B. Riley’s $35 revision was prior to the Phase 2a results. Correct me if I'm wrong, though.

I mean, what if FX-322 is killed/shut down (e.g., due to incapacity to objectively prove improvements in audiograms or EHF) before Frequency Therapeutics can conduct specific trials on specific subjective conditions? I feel like FX-322 is hanging by a thread, with Phase 1b serving as the thread...

This is what worries me the most, to be honest. What if FX-322 actually regenerates some inner structure (synapses and whatnot) improving subjective conditions (tinnitus, hyperacusis, WR, intelligibility, etc.), but it is shut down because it cannot be proved objectively?

Phase 1/2 showed [statistically significant] signs of functional hearing improvement.

Yes, sorry. I should have specified. I don't know who exactly, though.

Someone literally said yesterday in the investor conference that the weekly injection was "too much, too soon."

Agreed. I guess they could rebuild investor confidence by providing more information on Phase 2a and what exactly failed... if what was flawed was the trial and not FX-322, of course.

Good luck finding funding after Otividex's second failure and FX-322, though.

Novartis already tried that and shut it down after 8 or so years.

That is why I have been repeating for hours that biased data produce biased results. You literally cannot extract anything helpful from biased data. Every piece of information is unreliable in one way or another. Of course, this only applies if Phase 2a design was actually biased as they said...

IIRC, they said they haven't analyzed tinnitus results yet. They did say anecdotally that one patient did not see improvements, though, but you cannot infer anything from that. Someone please correct me if I am wrong.

You should all take a break from Tinnitus Talk and researching info on Frequency Therapeutics or anything related to tinnitus. It is not doing you any good. This is a massive setback, yes, but it is not the end of the line. Phase 2a was apparently biased and proved nothing. The drug is not dead...

That is correct. However, Phase 1b did show statistically significant improvements in speech intelligibility and WR. And regarding EHF, they didn't see improvements "at this stage," meaning improvements may appear after day 90.

This quote refers exclusively to Phase 2a. If Phase 2a was really biased as they say, every. single. result. inferred from it is biased. Good results (if there are any) and bad results. Biased results are unreliable and you simply can't assume anything, either good or bad. People lied to enter...

"improvements were not discernible over placebo" = "there were no statistically significant improvements in either group at all"

That is no how statistics work. Biased data produce biased results. You can't just simply pick unbiased results from biased data because every single thing is biased in one way or the other.

Dude, if results are biased as they say, they are literally useless. They don't prove absolutely nothing, neither that the drug works nor that it doesn't. Biased results = discarded results.

They have observed no changes in tinnitus, though they don't have the full data yet.

Multiple doses in four weeks were "too much, too soon."

They are saying that they are pretty sure that people faked their inclusion as they found inconsistencies when analyzing the data. So results are most likely biased and garbage. Phase 2a is officially ruined.

By the way, they observed a significant higher rate of adverse events in higher injections cohorts. Phase 2a single injections were safer, but were also found to have more adverse events compared to Phases 1/1b/1-2 single injections. They just said that multiple dosing is not a viable option...

If any of you is interested, the investor presentation has begun: https://edge.media-server.com/mmc/p/gheyi6hn

More interesting quotes from Frequency Therapeutics regroups as hearing loss med falls short in phase 2: “It’s some of the first evidence we’ve got to indicate that maybe hitting the ear once a week for four consecutive weeks with these materials is just dampening the ability of the ear to...

As per this interview: “It’s fair to say we have more phase 2 work to do. Some of these things we uncovered out of the four-injection study, we really want to home in on as we begin to think about what a pivotal trial design will look like in the future,” he added.

If the trial was actually misdesigned as they said, you have to rule out absolutely everything of the study. Every estimation would be useless because of bias.

Where did they state that? I think they are just comparing Phase 2a weekly injections to Phase1/1b single injection, not Phase 2a single injection to Phase 2a multiple injections. Might be wrong, though.

Here is the PowerPoint presentation with more information on Phase 2a: https://frequencytx.gcs-web.com/static-files/4a540e6b-b160-4e35-b487-5c82d264103b

Phase 1b remains unaffected because it is a separate trial with a different design. They actually proved again that a single FX-322 injection is sufficient to regenerate some hearing. This is not the end of the line. Stocks will tank (already tanking in pre-market); just let's wait a little...

I don't think you can infer that from these results. In fact, they admitted they may have screwed up the trial design as the placebo group reported improvements, which is unprecedented. If they did screw up, the whole Phase 2 is completely useless.

Results are out: Frequency Therapeutics Releases New Data from Two FX-322 Clinical Studies; Plans to Advance Single-Dose Regimen Not good, though.