Street Novelist
Member
- Apr 2, 2018
- 290
- Tinnitus Since
- February 2018
- Cause of Tinnitus
- Listening to loud music through headphones
True, but they still know if it works.The first trial was just for safety.
True, but they still know if it works.The first trial was just for safety.
FGG... So I have a quick question for you. If you have noise induced hearing loss, for instance a V knotch at 4,000 Hz (-40 dB) and your conductive tests are the same as your PTA tests (-40 dB), is it your opinion that FX-322 could increase both if the drug actually works?If you have audiogram changes (and it's not from conductive losses), then you at least have OHC loss so yes, this should help.
I'm very optimistic too. When you say they know if it works, what do you mean? I think we need the trials to figure that out.True, but they still know if it works.
If the line is the same, it means you don't have conductive losses.FGG... So I have a quick question for you. If you have noise induced hearing loss, for instance a V knotch at 4,000 Hz (-40 dB) and your conductive tests are the same as your PTA tests (-40 dB), is it your opinion that FX-322 could increase both if the drug actually works?
Every ENT has told me my V notch (both ears) is noise induced (nightclubs, ear buds etc) AKA nerve loss. Could FX-322 raise both, your conductive audiogram as well as PTA test results? I'm a little confused on this issue...
Without question, ENT offices will be overloaded with wait lists the first few years. In the US, there simply are not enough offices to handle even 10% of potential market attempting to schedule appointments. Many assumed that having an established ENT will help get you an appointment. It's highly possible that we see more practices spring up that specifically focus on hearing regeneration; or that Audiologist practices begin seeking some type of certification/education on intratympanic injections to treat patients with FX-322 without referral.Ironically enough, I'm also concerned about the long waitlists once the drug starts getting lots of press. Is the drug easy to manufacture and distribute? I think that is mostly Astellas's end, right.
Hopefully, those injected back in 2018 saw improvement, no matter how small; even at just 1 dose they should have noticed something.I'm very optimistic too. When you say they know if it works, what do you mean? I think we need the trials to figure that out.
I'm sure once they know the stuff works, they will want it out as quick as possible. Gotta make that money while they have a patent.Without question, ENT offices will be overloaded with wait lists the first few years. In the US, there simply are not enough offices to handle even 10% of potential market attempting to schedule appointments. Many assumed that having an established ENT will help get you an appointment. It's highly possible that we see more practices spring up that specifically focus on hearing regeneration; or that Audiologist practices begin seeking some type of certification/education on intratympanic injections to treat patients with FX-322 without referral.
As for production... Astellas is ONLY the manufacturer for FX-322 to be manufactured, distributed, and sold in NON-US locations. Frequency Therapeutics plans to use a US-Based Contract Manufacturer for US-ONLY distribution. These same type of contract manufacturers are used for mass-producing the COVID-19 vaccine by Moderna and Pfizer in the US. Frequency Therapeutics has not yet announced which manufacturer they will select for US-ONLY manufacturing and distribution of FX-322, this will be a priority of their new Chief Manufacturing Officer hired in January.
From what we know, and what Frequency Therapeutics has routinely said in investor webinars is that since FX-322 is a two-molecule drug, they persist that it should be "cost-effective and simple" to manufacture in mass quantities. We know that 1 molecule in FX-322 is Sodium Valproate; which has been manufactured for a better part of a century and is relatively cheap. The other proprietary molecule, which I cannot recall right now, is more expensive to obtain from a lab, but not prohibitively more expensive. It seems that separately, the molecules are readily available, which is promising.
What we don't know yet that may affect final distribution are things like: Storage requirements (does a doctor's office need a special fridge?), how the doses will be sold (do you have to buy them in a set of two doses?), down-line supply challenges (how much Sodium Valproate and the other molecule are available to ramp up millions of doses worldwide)?
I'm very optimistic too. When you say they know if it works, what do you mean? I think we need the trials to figure that out.
They did see improvement, there is data on this from Phase 1. Or what do you mean?Hopefully, those injected back in 2018 saw improvement, no matter how small; even at just 1 dose they should have noticed something.
At the end of March or early April.Can someone tell me please when will we know if FX-322 works for tinnitus? Any estimated date?
Thank you for the answer. That's around the corner.At the end of March or early April.
They saw improvement in word-in-noise scores. That was it.They did see improvement, there is data on this from Phase 1. Or what do you mean?
And anecdotal evidence of tinnitus reduction, but if we exclude that, yes, improved WiN scores, which is results that shows that it works? Sorry, maybe I'm misunderstanding your original statement.They saw improvement in word-in-noise scores. That was it.
I actually meant word recognition scores. Anyway, that's not going to help any of us. We are looking for audiogram improvements. While I think it is going to work, to say it works for sure is not true.And anecdotal evidence of tinnitus reduction, but if we exclude that, yes, improved WiN scores, which is results that shows that it works? Sorry, maybe I'm misunderstanding your original statement.
I guess you mean specifically for tinnitus/hyperacusis-related ailments? I think we are talking passed each other. The bottom line is; the drug does work in terms of repairing hair cells, but whether that will help everyone with tinnitus/hyperacusis "for sure" is not true, correct.I actually meant word recognition scores. Anyway, that's not going to help any of us. We are looking for audiogram improvements. While I think it is going to work, to say it works for sure is not true.
Word score improvements (WR & WIN) indicate that the brain is receiving more detailed signal from new hair cells (IHC and OHC), and is therefore able to distinguish the fine differences between syllables in words. In particular, consonants. If you agree that tinnitus is perhaps a symptom of the absence of hair cells, this may be the first indicator that hairs are filling back in areas where there previously was tinnitus present.I actually meant word recognition scores. Anyway, that's not going to help any of us. We are looking for audiogram improvements. While I think it is going to work, to say it works for sure is not true.
What do you mean by that? Do you know something we don't? They said they will release the results at the end of Quarter 1. March is the last month in Quarter 1.Go ahead and move that March/April estimate ahead a few months, just so you're not disappointed. None of this shit goes to schedule ever.
There seems to be a fundamental misunderstanding in much of this thread.I actually meant word recognition scores. Anyway, that's not going to help any of us. We are looking for audiogram improvements. While I think it is going to work, to say it works for sure is not true.
Rinri Therapeutics is developing a treatment using pluripotent stem cells and converting them into functional hair cells. I reached out to them last week and they stated that their treatment would be effective for severe and profound hearing loss as the treatment does not utilize support cells. They also said they are anticipating going into clinical trials 2-3 years from now (bummer I know). They presented at a webinar sponsored by Hearing Medicines Discovery Syndicate that I found very informative and can be found here:I think I once read there was a drug in development for severe to profound hearing loss, name beats me though. I was hoping FX-322 was all I was going to need up until this latest worsening :/
Why wouldn't they know at 6 kHz? Every hearing test I've had they checked that frequency. I've had them done at six different places.For example, of those that saw improvements at 8 kHz, we have no idea at what specific frequency the improvements stopped until the 4 kHz marker on the audiogram. Could have been 6 kHz, 7 kHz, or even 4.1 kHz.
0.25 Hz? Are we supposed to feel irregularities in the earth's rotation or something?In their January 2021 investor presentation, Frequency Therapeutics provided a little more insight on the 90-day readout.
Time to set expectations...
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You may feel a slight tickle.0.25 Hz? Are we supposed to feel irregularities in the earth's rotation or something?
It's so they know whether we can now hear the murmuring of our doctors when they say there's nothing wrong with us.0.25 Hz? Are we supposed to feel irregularities in the earth's rotation or something?
You didn't figure for the 4 doses that takes place after completing enrollment. So it was probably more like:Does anyone have any thoughts on when they think Frequency Therapeutics got (or will get) the Day-90 data and how long it will take to do their analysis?
They announced they had completed enrollment on September 22nd. 90 days from that date is December 21. My feeling is that means they would probably have gotten the data in early January. From there it'd probably take them around 6 weeks to analyze the data and put together a presentation. So that would mean we would see something at the beginning of March.
Am I missing something? The more I think about this, if my timeline is correct, they technically could put out something in mid-to-late February too.
You're right, I knew I had to be overlooking something. Yeah, the data is probably due to arrive in early February, so they either just got it or they'll get it soon. Mid to late March is probably the most realistic time to expect results.You didn't figure for the 4 doses that takes place after completing enrollment. So it was probably more like:
September 22: Last patient enrolled
1 week later: Dose 1
2 weeks later: Dose 2
3 weeks later: Dose 3
4 weeks later: Dose 4
8 weeks: 30-day assessment
By my assessment, they probably got the raw interim data this past Friday. If not, this week. I'd put it all at mid-March tbh. The Cohen Healthcare conference would be a good event to reveal the data.