This reads like massive denial. Buying more shares is straight up reckless. It's your money so do what you want with it of course. Just feels like someone needs to say that doubling down on an investment when the company has completely dropped the ball and the price has plummeted is very high-risk and low reward.I listened to the entire webcast from this AM - it's here for those of you who haven't listened.
I'm the least intelligent person on this thread BUT F*** people, there are a few things that stand out after listening.
1. Remember that while they were measuring tinnitus, they aren't recruiting for it. How do we even know how many patients had it. What if there were only the two we've heard anecdotes from? Carl LeBel's answers about EHF audiogram and tinnitus were basically "we didn't get anything." Seemed very much an after thought. But it sounds like the entire Phase 2a data is pure trash. Not worried. Re: The FX-322-111 trial, it causes me a little concern but that was only 30 patients. Maybe not one had tinnitus.
2. They announced clinically significant results from the single-dose FX-322-111 trial that also came out today. Not from a previous trial.
3. They're moving forward with single-dose.
4. I bought 500 more shares.
5. Lucchino also mentioned they were combing 'social media' for conversations people were having about not being admitted to the trial based on not hitting the WR criteria.
I don't think this is dead at all. I'm long FREQ.
I'm confused. How would they know they only got two doses of FX-322 if everyone, including patients, is still blinded at the individual level? You even then say it was an unknown amount.They also had improved word scores and can now hear birds sing and crows. We both talked to the same person. They can also tell better where sounds are coming from. They also got only two doses of FX-322. This is an older gentleman who I doubt would lie to get into a trial.
Honestly I heard from someone who's very involved in the trials that they thought it was a miracle that after someone was treated with an unknown amount of placebo or FX-322 they were able to understand what was being said with her back turned while before that she had had to take her mask off to talk to them.
I'm at a loss, I truly am, I'm seriously debating saying to hell with it and just getting cochlear implants, man. I can't go on the way I've been struggling everyday and now there's no telling when this will come out or even be available.
I'll admit I know next to nothing about those devices. But isn't she taking a very long time?What about Susan Shore's device? Isn't that the device that has actually made @kelpiemsp get over his tinnitus?
https://www.tinnitustalk.com/posts/416875/
Thank you! Otonomy is doing their 3rd or something Otividex trial and still haven't given up. People act like failing a clinical trial means that they're just going to accept defeat and go home.Frequency Therapeutics will eventually zero in on successfully treating sensorineural hearing loss, it is only a matter of time. It is back to the drawing board to unlock the answers we need, the signal is there.
No way have we been misled. The data was reviewed by third parties AND the FDA. Besides, there's the fact that several scientific A listers are on the Frequency Therapeutics Team; they wouldn't ruin their reputations to make a quick buck.I'm confused. How would they know they only got two doses of FX-322 if everyone, including patients, is still blinded at the individual level? You even then say it was an unknown amount.
I've just woken up and all I feel about this process is complete and utter anger because I've realised there's only one of two possibilities: either this drug doesn't do anything in humans and we've all been misled, or a bunch of selfish, desperate people have knowingly lied to get into the trial and potentially ruined the one and only chance for the rest of us to rebuild our lives. I am livid. If you are one those patients and happen to be lurking this forum, I only have two words for you. No prizes for guessing what those words might be.
She's been taking her sweet time, but barring another pandemic, their current Phase 2 trial should conclude this year with results out middle of next year. Medical devices only need to go through a feasibility and pivotal trial before applying for FDA approval so presumably if the results from this trial are good, they'll seek FDA approval after this.I'll admit I know next to nothing about those devices. But isn't she taking a very long time?
Does the device work? At all?She's been taking her sweet time, but barring another pandemic, their current Phase 2 trial should conclude this year with results out middle of next year. Medical devices only need to go through a feasibility and pivotal trial before applying for FDA approval so presumably if the results from this trial are good, they'll seek FDA approval after this.
Someone literally said yesterday in the investor conference that the weekly injection was "too much, too soon."I think they ran into issues because they weren't allowing the prior dose to effectively settle and proliferate. I think their dosing schedule was way too fast, but I didn't think it would absolutely obliterate the entire point of Phase 2 like it might have.
Their Phase 1 was encouraging enough for them to pursue a Phase 2. This doesn't detail out the exact data from the trial but does provide a pretty good overview.Does the device work? At all?
Let's say FREQ goes under (which I don't think will happen), someone will buy the PCA system. There's a myriad of hedge funds and venture capitalists ready to drop millions on this, it's going to be a multi billion dollar business.Don't give your hopes up. We've seen it in the Phase 1/2 trial, the drug IS working. Maybe just multi-dosing wasn't the right approach. I think there's no one who does his homework right the first time.
5 years ago, we weren't even near to a possible solution. Now there are a lot of companies that want to treat hearing loss. We are very close to something that would help us. It's just a matter of time. Keep on fighting!
The answer is no: not one person in their Phase 2a improved on the audiogram, including extended high frequencies. Furthermore, they apparently ran a parallel new Phase 1/2 trial. Again, not one patient improved on the audiogram, including extended high frequencies. Listen to their webcast from yesterday, last few minutes.Please tell me what I want to know the most.
Did Phase2a improve anyone's dB of EHF?
Didn't they say "there was no improvement in this cohort as a whole"?
Didn't even one person improve the dB of EHF at all in Phase1b FX-322-111? Or did they say that "the subjects as a whole did not improve"?
In both cases, if no one has improved at all, Phase 1/2's 10 dB (8 kHz) and 5 dB (6 kHz) will be fluke, mistake, and meaningless.
The credibility of hair cell regeneration becomes questionable.
I don't know how it was expressed, so please let me know.
Someone from FREQ?Someone literally said yesterday in the investor conference that the weekly injection was "too much, too soon."
Yes, sorry. I should have specified. I don't know who exactly, though.Someone from FREQ?
I really don't see this happening. Single dose has been more effective with FX-322. It's just how to get FX-322 deeper in the round window whether that is by reformulating or additional doses monthly.Let's say FREQ goes under (which I don't think will happen), someone will buy the PCA system. There's a myriad of hedge funds and venture capitalists ready to drop millions on this, it's going to be a multi billion dollar business.
We keep praying and praying but today I came to the conclusion that God has hearing loss himself.Just please hang on, everyone.
Me too bro, me too.
Weed out the fucking liars and inject once every 3 weeks or something. I think they have a real shot a getting this one to market and then FX-322 V 2.0 will be reformulated.I really don't see this happening. Single dose has been more effective with FX-322. It's just how to get FX-322 deeper in the round window whether that is by reformulating or additional doses monthly.
I think God must hate me for some reason.We keep praying and praying but today I came to the conclusion that God has hearing loss himself.
So not all bad news. I'll be interested to see what the Day 210 results show. It still doesn't make sense to me that we have a positive anecdote that had meaningful improvements in word scores and 3 frequency bands. Also the positive patient has no tinnitus after 5 months from his last FX-322 dose and can hear birds and sing, that is a miracle.Weed out the fucking liars and inject once every 3 weeks or something. I think they have a real shot a getting this one to market and then FX-322 V 2.0 will be reformulated.
This is a moot point now anyway, they'll try to release it as a single dose treatment; silver lining is that the trials will be shorter.
No, Dr. Shore helped @linearb.What about Susan Shore's device? Isn't that the device that has actually made @kelpiemsp get over his tinnitus?
https://www.tinnitustalk.com/posts/416875/
Same here. I am not even praying for healing anymore, I pray for death.I think God must hate me for some reason.