Search Results

And the other one was me. I didn't predict the company would commit fraud in my opinion. On April 8th, 2022, the company filed an 8-K with the...

I for sure am. I was prepared to accept the failure of FX-322 but for the company to decide to scratch the entire FX-345 program in one fell swoop...

Yea, I’m selling most of my shares. I was not anticipating them discontinuing both FX-322 and FX-345 at the same time. They went from having 3...

I'm holding long term, I pay no attention to the short term price fluctuations. No insider has bought any shares in the last year and a half.

There really isn't much to elaborate on. The stock has had dozens and dozens of 10% up and down days over the last 2 years for no reason at all....

No.

It means the stock went down 10% today; it's the nature of small market cap, no revenue generating biotech. The study's primary completion date...

Really depends what share price we end up at right before data drop. I think it's reasonable that we could double up overnight to anywhere from...

Looks like you may benefit from FX-345 based on where your notch is and if FX-345 penetrates as deeply as they are predicting. As for Viagra &...

Correct, they haven't changed the formulation for FX-322. You may look at it as "but only showed improvements in word recognition scores" but that...

Its completely fair to be skeptical. Just keep in mind that the brain can do some weird and amazing things. I'm not going to discount the chance...

That is the whole point of FX-345. Its an improvement on FX-322 in that their goal is to get the compounds deeper into the cochlea so that they...

Purely speculation on my part but to me it seems that is sort of a sweet spot for FX-322 responders. The biggest factors at play are the cochlear...

Yes, that is actually a pretty accurate description of what some of the science has found is occurring. Tuning out the noise: Limbic-auditory...

Administration of FX-322 didn't reverse his disease instantly, it occurred approximately 30 days after treatment. 4 weeks is not an unreasonable...

What science or clinical data do you have to prove that hearing can only come back gradually after regenerative treatment? There are too many...

With the nature of how they are regenerating the hair cells, it is supposed to be permanent. You may have read "responses lasted 1-2 years" but...

FREQ is currently targeting the moderate to moderately-severe range of hearing loss patients in the noise induced and sudden etiologies for the...

Yes.

I believe it's about 9 patients or so they are truly only testing for safety on first. Once it appears safe in the first subset of patients, they...

While it could potentially be a good pairing for FREQ to pick up some of the OTIC patents, FREQ doesn't have the cash pile to afford it right now....

In that case, then I will have to disagree with the statement you made saying "If FX-322 doesn't work, then there's little chance that FX-345...

The results of FX-345 are not contingent on the results of FX-322. The company always intended to conduct the FX-345 trial regardless of the...

The company has said that they will re-visit multi dosing later on down the road. Their main concern right now is to get it to market ASAP in...

Agreed. Seems unlikely they will discuss the Phase 2b trial results next week as they still have at least 1 patient that needs to complete their...

Previous guidance said they would publish the results in either Q4 of 2022 or Q1 of 2023.

Q1 readout means the data will be shared sometime between January 1st 2023 and March 31st of 2023. The studies' primary completion date is January...

They word it that way because that is the farthest out they tested subjects. Another way to word it would be to say “the benefits from a single...

That's fair, my mistake. I wasn't aware of that one as they make no mention of it on their pipeline. Most biotechs keep drugs listed on their...

OTIC was founded in 2008 and has been plagued with failure after failure as evidenced by the fact that they haven't brought a single drug to...

I will be watching it. Anyone can register to watch. When filling out the form, just say "Retail Investor" for the company you are with.

I can't say I have much interest in discussing if their strategy is suboptimal or not. You have to be able to walk before you can run. We could...

FREQ is regenerating hair cells from progenitor cells with FX-322, they are not targeting the nerve with their compound. In their pre-clinical...

Yes.

Mid-stage refers to the fact that it is Phase 2 which is considered the middle phase. It is referencing the readout we are waiting for in Q1 of 2023.

Biotechs operate year round. If they didn't run trials during holiday season, then they would just be sitting and waiting while burning cash daily.

The tradition used to be that you needed 2 pivotal trials in order to apply for FDA approval but, over the last 15 years or so, approximately 53%...

OTO-413 failed at a higher dose. Otonomy Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with Hearing Loss

It's a guessing game as to what adding additional participants could mean. Maybe they have low confidence so they wanted to add more participants...

There still is a chance but for how big or little it is, I don't know. I don't think they'd get to skip it completely but they could end up...

They've done about all they can to make it as reliable a study as possible. To gain admittance you need an audiogram that is at least 6 months old...

Trial enrollment completion was announced this morning. With 90 days to go for the last subject + another 30 days or so for them to crunch the...

You're losing the forest for the trees and you're thinking like a tinnitus sufferer rather than a hearing loss sufferer. You have to look at the...

Really depends on the closed door conversations the company has with the FDA. It was always considered the tradition that you needed 2 pivotal...

I don't really compare OTO-413 to FX-322 as it is comparing apples to oranges in my opinion. They work on completely different parts of the...

Too many people have too high of expectations for this space. Expecting them to cure hearing loss with the first ever drug to be potentially...

Don't lose the forest for the trees though. They have seen consistent results from their Phase 1/2 study & their open label study where they saw...

Statistical significance is twice the bar of clinical significance. Clinical significance is considered a 5 word improvement, statistical...

Seeing that there are no other treatments on the market, all they would need to do is show statistically significant improvements over placebo in...

FX-345 data release has been pushed back to the 2nd half of next year per that slide deck. The most exciting tidbit in that updated slide deck is...

See their expanded access policy. FX-322 could be commercially available as early as the end of next year if the FDA accepts their current trial...

To quote the company: "a review by the Company of available historical data from audiograms taken before the study, showed many study subjects...

The largest reason it failed was due to an unprecedented placebo response. The issue isn't that no one responded, the issue is that too many...

In their preclinical work, after dosing a mouse cochlea with FX-322, there were 6 rows of outer hair cells present rather than just 3 so this...

No, higher frequencies are easier to treat than lower frequencies based on their proximity to the round window membrane. The biggest risk I see...

The new hair cells that are created using FX-322 do form synaptic connections. The original damaged hair cells that are still in place and have...

Carl LeBel said on the HLAA Q&A earlier this year that their compounds activate both inner and outer hair cells. I speculate that it has more to...

A pure tone average at the Screening Visit of 35-85 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz in the ear to be injected. While it may seem...

Lots of research in recent years is pointing to the ultra high frequencies helping with speech perception, especially in noise. Extended high...

This lines up with FREQ's age-related hearing loss trial, they did not see a robust response in that trial which also suggests age-related hearing...