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It's not 15 months away, but it's the closest so far. It's the only pill in Phase 3 where we are 100% sure that some people will benefit from it....

It's adjusted one quarter back, unfortunately. Yes, I think this is our only bet in the coming 12-15 months. Calming down hyperexcitability is...

From the Q4 investors call this week:

I might visit the symposium, I live 30 minutes away. Thanks for sharing.

I think reactivity is caused by hair cells that are damaged/vulnerable but not yet broken. These hair cells are much more susceptible to noise...

That is approval to trial. Not approval to market.

Fits like a glove to Auricle. Trade/Device Name: Lenire Regulation Number: 21 CFR 874.3410 Regulation Name: Combined acoustic and electrical...

It is completely normal to submit almost 2 years after completing your final trial to the FDA for a class II device which has an equivalent...

The results are promising but as with 99% of all research, it will likely not be followed up. I don't see why it would bring lasting effects for...

→ Saniona’s CEO: ”Selectivity is the cornerstone of future epilepsy treatments” Saniona is next in line to develop a Kv7.2 drug. This one is...

Second half 2024 could be anywhere between July and December. Trial completion will be at the end of 2024. Best case scenario would be essentially...

Why? I just estimated Q3-Q4 2024 and that is exactly what second half year means which they are stating. Right on spot. This is very good news!...

The date on ClinicalTrials.gov is a placeholder and not based on facts. They said there is no known estimated completion date. I'm gambling for...

Xenon Pharmaceuticals has their Q3 update call on the 8th of November. This call will be important for the timelines of XEN1101.

The abstracts for the 2nd Kv7.2 Channels Symposium are online: 2nd Kv7 Channels Symposium: Programme Seems like Dr. Thanos Tzounopoulos didn't...

No, this hearing loss is the same as any other hearing loss. For a clinical trial you need to narrow down a sickness/situation that is the same...

Who is hyping what? Where do you see hype from Auricle? We obviously set the bar of expectation way too high. They clearly fundraised at the...

As I said, there is insufficient data and safety information available for compassionate use of tinnitus. They will not accept off-label for...

I strongly suggest to use pain as criteria instead of tinnitus (or hyperacusis with pain). Compassionate use is only for the indication being...

There are no NaV1.8 blockers on the market at this moment as I am aware. I'm no scientist but the pain/tinnitus comparison is from...

For people with noxacusis, I'd follow the trial of VX-548 of Vertex Pharmaceuticals which might be of interest. It has 5x Phase 3 trials running...

Because there is no mention of two people without tinnitus in the paper? This was in the first study. I'm not sure where that question came from....

Here are my findings from the earnings call, I hope this is helpful. Unfortunately no guidance was given during the call yet, although the topic...

From my understanding, even though speculation, I think the funding / investor is private equity and not big pharma. We need a large company...

Thank you for summarizing @Markku. Nicely formatted too.The only answer that for me was really helpful is the following: I'm hoping that she...

Sensorion Reports Positive Efficacy Data from SENS-401 Phase 2a Clinical Study Positive preliminary data showed SENS-401 has a clinically...

I'm actually very sure of this progressing through Phase 3 if no severe adverse events are found. At least 4 companies worked on New Drug...

I think we will know more or less the ending date at the 10th of August Q2 quarterly figures call. The date on the trial page is just a...

19 months was including launching the new study as per requirement of the FDA if I'm not mistaken. I'd say it's very likely that they started as...

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants There are two trials ongoing for CB03...

The program of the symposium is online on their website. As expected, tinnitus is on the menu. Prof. Thanos Tzounopoulos will speak on tinnitus...

Some findings: - People with more somatic tinnitus modulation movements benefited better, but it's stated that non-somatic tinnitus should also...

Prof. Shaowen Bao will present on the influence of inflammation and TNF-A on tinnitus next week at the TRI 2023. There has been a clinical trial...

Good question. It looks like it, but I'm not sure.

@Nick47, a different Kv7.2 modulator currently being trialed in China is Pynegabine HN37. It already completed Phase 1 and is moving to Phase 2....

They expanded the number of candidates and are apparently open for recruitment again. They postponed the completion date to September, unfortunately.

I just want to chip is as a professional dentist customer (visited too often in the last year for several root canals due to an incompetent...

Where am I spreading negativity? I'm stating the facts and basically saying the same thing as you. She will stop teaching and stop researching...

Susan Shore officially retired, as per last week, from the University of Michigan and will have Regent status. (Source: PDF) I guess this...

You know, I have been dealing with neuropathic pain for some time now in parallel with tinnitus. Neuropathic pain shares a lot of similarities...

No, they are shifting away because they are creating a pediatric version of XEN1101. Also, the age group for XEN1101 has been extended in the...

I cannot comment on potency. All we hear from the companies is that their product is best in class. Everyone claims the same. There are two...

XEN496 program has been killed mid Phase 3 and they are shifting the focus to only XEN1101. This was reported in the Q1 financial call of Xenon...

I'd say so. I wouldn't be surprised if it influenced neuropathic pain too as antiepileptics are known to calm down nerves. Antidepressants and...

I think so. Yesterday I stumbled upon another Kv7.2 trial in Phase 1. I forgot to bookmark it but there are more companies working on this.

ClinicalTrials.gov: Evaluation of Auditory Mirror-Therapy for Tinnitus The primary endpoint of the trial has been reached.

See here the classification again for ear, tongue or skin stimulation together with acoustic stimulation for treatment of tinnitus. They are...

What I'm saying is that the De Novo route is a different route then a normal 510k with different requirements, different forms and a different...

I'm afraid that, because Auricle took the De Novo route at FDA, things are unfortunately delayed as the device is no longer De Novo because...

It took 1.5 years. The submission date was August 2021. It has been categorized as De Novo class II device. One of the risks stated was an...

In last week's investor call, questions were asked on the Phase 3 timeline. Unidentified Analyst: Hi, this is James on for Paul. Thanks for...

BHV-7000 completed its Phase 1 successfully. Preliminary Safety: Single doses up to 100 mg and multiple doses up to 40 mg daily x15 days...

It clears the path for Dr. Shore (Auricle) to have a faster approval because it is not a De Novo technique/device anymore. This is good news in my...

Hi @Markku, my gut feeling is that it is related to the color sensory treatment. But then again, very little information is known. It went through...

Don't forgot the University of Leicester who have been working on a tinnitus device for 8 years already, which very little is known of:...

Xenon Pharmaceuticals is estimating the trial to last 2 years, just like Phase 2, with an estimated ending of late 2024/early 2025. They stated...

A role for KCNQ channels on cell-type-specific plasticity in mouse auditory cortex after peripheral damage A new paper by Prof. Tzounopoulos. It...

It surprised me that they measure tinnitus loudness. Might be the GABA part. I think their aim is simply getting a tinnitus approved indication...

I guess the actual goal or Brexanolone for tinnitus might be treating tinnitus/hyperacusis related depression. Their launch focus is treatment...