Search results for query: *

Please let me know if you know. If you don't know, I would like to hear your opinion. There is an eye medicine in their concept. Can macular degeneration be a target?

Don't those prospective drugs contain both a GSK-3 inhibitor and an HDAC inhibitor?

For example, if the contract contains the following text, isn't Astellas entitled as stated in the annual report? "Similarly, if any other products containing both a GSK-3 inhibitor and an HDAC inhibitor are approved, Astellas has the right to commercialize in countries other than the United...

I wanted to say that the current contract is about FX-322. And by your post, I understand the logic that the parties may be exempt from new contracts and contract extensions for FX-345. Since the exemption is not a decision, I think it is necessary for both parties to confirm their intentions...

Enzalutamide (Xtandi) currently sells $3.5 billion annually. It is a drug for prostate cancer. How many FX-*** patients will eventually be in the world except the United States? In addition, including multiple injections and re-injections after recovery, I think it's likely to be well over...

Astellas paid $3 billion when it acquired Audentes Therapeutics. In the future, Astellas will benefit in all countries except the United States with FX-***, which provides a hearing-restoring effect across the cochlea. The royalty paid to FREQ is about 10%. Given the number of non-rare...

I hope that FREQ will develop drugs that improve small molecules and gels such as FX-4 **, FX-5 **, and FX-6 **, and ultimately have a better effect on the entire cochlea. I'm looking forward to it. I hope they will work hard to improve even presbycusis with stronger or different types of GSK-3...

What is stated in the annual report means that Astellas has exclusive marketing rights to FX-322 and similar drugs in countries other than the United States. It means that Astellas has the same exclusive marketing rights as FX-322 for similar drugs that will occur in the future. Determining...

Is that your idea? Is it speculation? Did the contract text state that the improved version is also covered? Astellas does not have a patent. They signed a contract with Frequency Therapeutics when several people saw a 10 dB improvement at 8 kHz from FX-322. $545 million would be too cheap if...

There is a contract that they will be rewarded from Astellas for completion and sale of FX-322. Furthermore, if FX-322 is successful, I think they can get a good contract for FX-345. "Frequency is bagging $80 million now, but stands to pick up another $545 million down the line in development...

I agree. And if the improved gel itself penetrates deeper, I think it will be more effective.

https://investors.frequencytx.com/static-files/bd82e199-8b2c-4c35-9929-3d7ed4cbcfc2 Please read page 15 of the report.

If you want to change the concentration, it will be a different drug and start over from Phase 1. You can avoid "redoing" by starting with a group of different concentrations from the beginning. The difference in the strength of the effect is, for example, 5 dB, 10 dB, 15 dB for improvement at...

What does "Formulation enabling evaluation of a range of dose levels" mean? Does that mean "FX-345 has different types of concentration"? They have learned in Phase 1b that the effect of a drug is influenced by concentration, not volume. Is this an achievement of the lesson?

Was TFI a survey item in Phase 1b? Since there was an anecdote about improving tinnitus, wasn't it adopted as a survey item in Phase 2a? Originally, FX-322 is a drug whose purpose is not to improve tinnitus but to restore hearing.

They state that Phase 2a could not confirm the effect of the drug for at least two reasons. One is the unusual effect of placebo and the other is multiple injections per week. In addition, I think that the short-term multiple injections that inhibited the effect also include placebo...

What do you think is the reason why TFI was not published in Phase 2a? 1) It really didn't work. 2) Since there were many improvements in placebo, it could not be said that it was effective in comparison. 3) There was improvement in the medication group, but because there were many improvements...

Slide P28 from March 2021:

Unfortunately, I only know that it has improved by 10 dB or more. These four people seemed to be the same people with moderate hearing loss with significantly improved word recognition. It was announced that these four people had moderate hearing loss. But, I think there may be people with mild...

Slide P33 in October 2019. It was an improvement of 10 dB or more. In a slide created after this, probably one year later, one of the four had an improvement of 15 dB. P22 on the same slide. They said it would reach up to 4 kHz. 4 kHz is the area where noise first attacks and destroys hair...

I want Otonomy to show evidence. I can't believe their gel actually penetrates the entire cochlea just because they have a patent. Why is it just a claim? Do they have evidence from clinical trials? I think there was a patent that FX-322 also reached 4 kHz. But it didn't actualize.

A mere claim without references is hard to believe. The possibility that FX-345 will reach 4 kHz and have an effect must be calculated based on the data of FX-322. Data such as gel performance and drug concentration. I think there is a possibility of success of FX-345.

I think this is because in Phase2a, there was an improvement in the placebo group that canceled out the significant improvement.

I heard they seemed to say in the webinar that there was no improvement in EHFPTA in Phase 2. Do you think this means "compared to a placebo"? Do you think EXFPTA had the same problems as word recognition? I think a cheat that doesn't hear a beep is easier than a cheat that doesn't understand...

They (Frequency Therapeutics) said they would reach up to 4 kHz until the Phase 1/2 results were revealed. 4 kHz was their immediate goal. It turned out that it did not reach 4 kHz in Phase 1/2, and I think that they were immediately working on improving the gel as an improvement measure. At...

Is it registered as a trademark? They say it reaches the entire cochlea, but is there any objective evidence? Did you confirm the effect of the medicine up to 500 Hz?

I have the same idea. And if that premise is possible, I want them to do it and succeed. I would like to see that there is no depletion of sustentacular cells, which is an advantage of FX-322, and the effect is cumulative with each injection. Multiple injections in a very short period of...

I would like to see another Phase 2b in 2022. A single (not continuous) injection at appropriate intervals (not weekly) for mild to moderate patients. They said they were thinking of implementing it. There is plenty of time for a year. If consultation with the FDA is difficult, they can be...

No drug works for all people and all symptoms. The important thing is to determine what works and what doesn't. And to maximize the effect and make it bigger. Then develop new drugs for ineffective symptoms. Hearing restoration is the development of a whole new field of medicine. It is...

To be honest, I don't know and understand how significant a 3.1 dB or 6 dB improvement with BKB-SIN is for patients with severe hearing loss. I also learned for the first time that the index of improvement in BKB-SIN is not "the number of words that can be recognized" but dB. How is BKB-SIN...

For that reason, I'm worried whether the video that FX-345 penetrates deeper is true. How far is the truth? That's why I posted about animal experiments.

I think that the truth may not be known without animal experiments with mammals that are closer to humans than mice. But I don't know what kind of animal it is. Is it only a mouse in the animal experiment of FX-345? I think that's not enough.

I'm confused because I don't understand the basics clearly. Were there any articles in animal experiments that they improved hearing in hearing-impaired mice? Was it an article about hair cell regeneration, not hearing restoration? Has anyone seen an article about hearing restores on all...

Initiating IND enabling studies.

This is a study of Kyushu University in Japan. It seems to be a technique for regenerating spiral ganglion neurons, not hair cells. It may be effective for presbycusis. This technology uses proteins rather than small molecule drugs. I want Frequency Therapeutics to be able to do the same...

And the big thing is the success fee paid by Astellas. It is very important to show that FX-322 is an active drug (especially in HFPTA) and get FDA approval. If successful, they can sign a better deal with Astellas for FX-345.

I don't think Phase 3 is necessary for FX-322 because there are no competing drugs. What about if FX-322 is approved, is FX-345's competitor FX-322? Do you need Phase 3 for FX-345?

There is a graph on page 4 where VPA does not penetrate deeply. https://www.tinnitustalk.com/attachments/improved-speech-intelligibility-fx-322-phase-1b-pdf.43487/ But, only GSK3i is listed in the FX-345 presentation on November 9th. Is increasing the amount of VPA an issue? Is it an error...

I understand. So it means that it will not be confirmed until the reading of 113 is completed. The reason for the white letters. 111 contained severe.

The size of these two circles is too small because the number of patients with severe hearing loss and the number of patients with presbycusis are about the same. Also, unlike the others, the numbers are white. I think they're probably writing that they're close to this. Because it has not...

Where can I find the materials for this presentation?

"Clinical data review from four completed FX-322 clinical studies, including 169 subjects with a range of hearing loss severities and SNHL etiologies (sudden, noise-induced, age-related)." Does this include clinical trials for severe hearing loss?

Did they measure PTA in FX-322-111? Or are they not announcing it because there are no significant improvements?

The severe hearing loss trial can fail, but in that case it will be Phase 2 (re-challenge) without severe hearing loss. The final conclusion is whether or not the re-challenge will produce good results.

There is no proof that hearing was regenerated. However, there are no reports that it has not been possible. The possibilities aren't gone. If that is possible, an improved delivery method may also improve deeper, lower frequencies in the cochlea.

I look forward to a detailed announcement of Phase 2a later this year. So far, only the number of occurrences of WR group level improvement of 10% or more has been announced. I hope that WR, WIN, PTA, the magnitude of changes at the individual level, and TFI etc. will be announced. I think some...

Is it a guess? If there is evidence, isn't it a breach of stock manipulation if they were lying? Have the legal proceedings actually been filed?

Then, there may be a possibility of improving PTA. After all, I would like to see detailed data at the individual level. Then, it is possible that some of the subjects who did not report tinnitus had existing tinnitus.

What does this part on page 2 mean? Is it just about WR? Does that mean that WR, WIN, and PTA (including EHF) did not show any effect over placebo? In that case, did neither those who received FX-322 nor those who received placebo improve PTA at all? Or was there an improvement in PTA that was...

Isn't an "adverse event" a side effect caused by an injection? However, there is no tinnitus in the placebo group.

Excuse me. Does "the lack of audiogram improvements" mean "there is no mention of audiograms"? Excuse me, but is there a statement somewhere on some page that says "there was no improvement in high frequencies"? https://investors.frequencytx.com/static-files/a26c03b8-d699-48a5-9bcd-ad980554065b

Does that mean FX-322 isn't dead yet? You still have hope, right? If so, I will be happy and cry.

It means whether they are injecting placebo into the candidate's untreated ears. By the way, in placebo-controlled clinical trials, I think that the only way to eliminate the bias is to select candidates by lottery.

I hope that the detailed disclosure of Phase 2a in the second half of this year will provide information showing that the drug is working. This 210 days of information is too little. I would like to see data on the magnitude of improvement in WR and dB at the individual level.

According to @Diesel's memo, wasn't the announcement postponed to the second half of this year? Will it be announced in August / September?

Speculation is just speculation. Moreover, our knowledge is inferred from limited information, no matter how hard we try. It may be completely off the mark. I'm looking forward to FREQ's report organized from the data. We are always speculating because their reports are slow and...

Inner hair cell priority is speculation in this thread. Frequency Therapeutics have not made such a statement.

The statement could be the number of patients who have improved, both in WR and audiogram. I think it may not be the magnitude of the improvement (increased number of words, improved dB). Previously, the content I posted assumes that assumption.

So far, no official announcement has been made. Also, I think they should have only obtained group-based significance information in the interim presentation.

Is there a possibility of early July for Phase 2A details?