Frequency Therapeutics — Hearing Loss Regeneration

[Lucifer]

If they don't reach their target amount worked out with the FDA beforehand, they won't release results until they do.

Wow that's a bummer. They should really start recruiting patients now. I wonder why there is a delay?

 

[FGG]

It was just one hierarchical model that demonstrates my point. Another would be neuropathic pain—treating the region of the brain that's malfunctioning or whatever, over localized nerve blocks.

I think when you are talking about regeneration, though, it wouldn't matter if you restore the cartilage in a joint or a ligament first (or the ankle before a knee) with the exception being a case where psychologically someone needs the first treatment to pack a bigger punch.

 

[FGG]

Wow that's a bummer. They should really start recruiting patients now. I wonder why there is a delay?

From what i can tell there is always a lag period between announcing a new location and recruiting in any study.

 

[mrbrightside614]

I think when you are talking about regeneration, though, it wouldn't matter if you restore the cartilage in a joint or a ligament first (or the ankle before a knee) with the exception being a case where psychologically someone needs the first treatment to pack a bigger punch.

Good point, I concede.

 

[Lucifer]

From what i can tell there is always a lag period between announcing a new location and recruiting in any study.

If the reason why they announced more locations is to get Breakthrough Therapy status then a little delay is not too bad if this is the case. But hopefully results come out around end of October at the latest.

 

[mrbrightside614]

If the reason why they announced more locations is to get Breakthrough Therapy status then a little delay is not too bad if this is the case. But hopefully results come out around end of October at the latest.

If they stressed hearing asymmetry I would qualify but my baseline hearing is too good... which is really f***ing me over right now unfortunately. These trials' inclusion criteria (even Shore) are so insanely picky IMO.

 

[KyleM]

If they stressed hearing asymmetry I would qualify but my baseline hearing is too good... which is really f***ing me over right now unfortunately. These trials' inclusion criteria (even Shore) are so insanely picky IMO.

Yeah I agree they are picky but man, it is what it is- they gotta do their controlled science shit. What we need is for these clinical trials to wrap up already and get real products out sooner. From all the clinical trials I attempted to participate in there was always so many caveats, almost making it not worth the effort.

We just need real products.

 

[Tweedleman]

If the reason why they announced more locations is to get Breakthrough Therapy status then a little delay is not too bad if this is the case. But hopefully results come out around end of October at the latest.

I honestly just want to go into cryosleep until they're ready to shoot me up. We're missing out on what could be the best years of our lives. I seriously hope the results are even better than expected.

 

[FGG]

I honestly just want to go into cryosleep until they're ready to shoot me up. We're missing out on what could be the best years of our lives. I seriously hope the results are even better than expected.

I actually feel like I somewhat understand why Michael Jackson wanted a continuous IV Propofol drip now.

 

[Pink Noise]

I honestly just want to go into cryosleep until they're ready to shoot me up. We're missing out on what could be the best years of our lives. I seriously hope the results are even better than expected.

We just have to keep going and try to get the most out of our lives until FX-322. (I'm really spiking at the moment - it's horrible).

 

[Lucifer]

If they stressed hearing asymmetry I would qualify but my baseline hearing is too good... which is really f***ing me over right now unfortunately. These trials' inclusion criteria (even Shore) are so insanely picky IMO.

Yeah I agree they are picky but man, it is what it is- they gotta do their controlled science shit. What we need is for these clinical trials to wrap up already and get real products out sooner. From all the clinical trials I attempted to participate in there was always so many caveats, almost making it not worth the effort.

We just need real products.

I honestly just want to go into cryosleep until they're ready to shoot me up. We're missing out on what could be the best years of our lives. I seriously hope the results are even better than expected.

They are very picky with meeting the criteria. I wonder if they use a margin of error if someone was very close at meeting the criteria but did not meet all the points.

 

[FGG]

Except your family and kids will continue on, and cryosleep will make you miss out on life events, much as tinnitus does..

Joke's on them, I have no kids and my husband left me when I lost my hearing. One cryosleep, please.

 

[FGG]

They are very picky with meeting the criteria. I wonder if they use a margin of error if someone was very close at meeting the criteria but did not meet all the points.

No. The criteria is set in stone. I know that much.

 

[Tweedleman]

So Audion's results are still due in April correct? At least we'll have that to chomp on soon and extrapolate on how it bodes for FX-322.

 

[Lucifer]

So Audion's results are still due in April correct? At least we'll have that to chomp on soon and extrapolate on how it bodes for FX-322.

I just hope there's not a delay with Audion/Regain results. At this stage still not too sure which one of the two will come out. Frequency Therapeutics could probably produce more batches of the drug due to funding from Astellas. Audion/Regain could still come out before Frequency Therapeutics depending on EU regulations and if they can release it quicker.

 

[Lucifer]

@FGG

How do you know that the four clinical trial locations haven't started recruiting yet? Does it state on the clinical trial's website or did you give them a ring?

 

[Diesel]

Here's the clinical trial link:

Many are recruiting, 4 are not yet:

https://clinicaltrials.gov/ct2/show/NCT04120116

 

[Tweedleman]

I just hope there's not a delay with Audion/Regain results. At this stage still not too sure which one of the two will come out. Frequency Therapeutics could probably produce more batches of the drug due to funding from Astellas. Audion/Regain could still come out before Frequency Therapeutics depending on EU regulations and if they can release it quicker.

Didn't Audion already delay P2 results once?

 

[FGG]

Didn't Audion already delay P2 results once?

Did they?

 

[Lucifer]

Didn't Audion already delay P2 results once?

Yes they were supposed to be released end of January but changed it to end of April.

 

[Lucifer]

Here's the clinical trial link:

Many are recruiting, 4 are not yet:

https://clinicaltrials.gov/ct2/show/NCT04120116

Cheers for that.

 

[Jaysterk]

The human cochlea has est 2500 IHC and est 13000 OHC. So, when they mention 15000, it's a broad reference. And appropriately generic considering the context of the presentation.

Doesn't hyperacusis originate from OHC damage?

 

[Jaysterk]

Slight chance it could be released next year depending on if they can receive breakthrough therapy status.

I honestly see this as highly probable.

 

[Serouj]

Why is Frequency Therapeutics' stock down to $21.7 ? It was $27.55 at the beginning of the month. Any ideas?

 

[Diesel]

Why is Frequency Therapeutics' stock down to $21.7 ? It was $27.55 at the beginning of the month. Any ideas?

All markets are down substantially over the past week; Frequency Therapeutics isn't immune to market volatility.

 

[Joly]

Where are the clinical trials for Audion / Regain done? I did not find it on their website.

 

[FGG]

Yes they were supposed to be released end of January but changed it to end of April.

I thought they finished the trial on time (January) and the "delay" is just that they haven't released results yet. I'm not sure what the normal time frame between trial completion and the release of results usually is so I am not sure if this constitutes a "delay" or not.

From Audion's website:

"Recruitment of patients for phase 2 commenced in January 2019 in Tübingen, Athens and London and recruitment has now been concluded, study finalised and data being analysed."

 

[WickedCarnival]

Development of additional lab space for Frequency Therapeutics!

https://www.post-gazette.com/busine...university-of-pittsburgh/stories/202002240120

 

[FGG]

Development of additional lab space for Frequency Therapeutics!

https://www.post-gazette.com/busine...university-of-pittsburgh/stories/202002240120

Is it for Frequency specifically? I didn't get that from the link.

 

[all to gain]

I really want FX-322 to work, but I wonder if we are all getting our hopes up too high. I don't want to be pessimistic or a killjoy, but what if it either doesn't get through the trials or on to the market or is shown to be not that effective? I feel many of us, me included, would be in for a massive anti climax.

Anybody else have these thoughts?