Frequency Therapeutics — Hearing Loss Regeneration

It kind of sounds like they are doing some damage control to avoid potebtially antagonising patients. Very ambiguous tweet though...
There is definitely potentially a "we are about to insult many trial participants and want to thank people and not sound ungrateful" angle.

And @ajc, yes trials do get cancelled sometimes but those announcements are not vaguely tweeted first. If Frequency Therapeutics did that, I would definitely lose some respect for them.
 
Fingers crossed. Also, no one mentioned anything about tinnitus scores in this trial... I bet the majority of us are interested exactly in this aspect of the drug?
The only anecdotes we got about tinnitus reducing are from Carl LeBel and the three positive anecdotes we got.
 
But you are then being a blind patriot towards Frequency Therapeutics if you think a multi million dollar company in a clinical trial didn't compute their p values correctly because it doesn't match the outcome you wanted!

Wow I have even less respect now!
You understand what I said so little that you don't even know how to critique it. I didn't say they incorrectly computed their p-values. What I said was that there was a highly useful post hoc calculation (for phase 1/2! I've been ripping part Phase 2 if you bothered to read the past 10 pages or so) that they could have showed off. But in order to arrive at this calculation, someone math literate has to read the Thornton and Raffin paper in detail to know the theory enough.

Don't get me wrong -- I am certainly not suggesting that I am the only one capable of doing this. Many people are capable of doing this. But it appears that they just went to the Thornton and Raffin 95% confidence interval table, found the numbers and saw if the word scores cleared them. That's different from computing p-values to quantify how much they cleared them by.

BTW, not to sound like an elitest (and trust me, people without degrees can sometimes do science better than people with degrees), but I do have a Ph.D. in math. I am a professional scientist.
 
There is definitely potentially a "we are about to insult many trial participants and want to thank people and not sound ungrateful" angle.

And @ajc, yes trials do get cancelled sometimes but those announcements are not vaguely tweeted first. If Frequency Therapeutics did that, I would definitely lose some respect for them.
With them usually being very well spoken and thorough, it is a bit of an odd Tweet. Maybe they hired a new social media intern? :dohanimation:
 
The only anecdotes we got about tinnitus reducing are from Carl LeBel and the three positive anecdotes we got.
I wonder if there is a way to get from Frequency Therapeutics what the tinnitus scores were in the current study... Probably won't change the direction of their business development, but still...
 
I wonder if there is a way to get from Frequency Therapeutics what the tinnitus scores were in the current study... Probably won't change the direction of their business development, but still...
They should have all of the tinnitus data available with the complete readout later this quarter.
 
I wonder if there is a way to get from Frequency Therapeutics what the tinnitus scores were in the current study... Probably won't change the direction of their business development, but still...
One of the anecdotes noticed his tinnitus reducing 90% around 3.5 months after the injection, so that's just after 90 days. I'm not sure if he had a gradual tinnitus reducing or if it suddenly dropped by 90% at 3.5 months.

@Aaron91, do you know?
 
I wonder if there is a way to get from Frequency Therapeutics what the tinnitus scores were in the current study... Probably won't change the direction of their business development, but still...
They did initially state that they would reveal tinnitus data with the 90 day group data-release, but it did not happen, and it's probably not a good sign. We will most likely get the final data and the TFI scores on the full Phase 2 read out at the end of June, though.
 
And what is your research based on exactly? Lies, lies, and statistics...

The only solid proof we have is from the trials themselves which clearly state the drug doesn't currently work!

You can do 10 page posts and try and boggle people but none of it is based on facts, just speculative garbage you've dreamed up to cling onto hope this works!
Aren't you meant to be a bear? Look, you, FGG, Aaron91, Zugzug might do these complicated posts about all the science etc, but don't you think the actual scientists at Frequency Therapeutics have done the same but with the actual data?

FX-322 doesn't work, and the science points to anything positive being from the placebo effect! Face the facts and move on guys!
Have you even read the discussion here? Do you understand the crux of the debate? Everything we have been talking about has been about what may have happened at the individual patient level and how that may inform the group level read-out. As of this moment in time, Frequency Therapeutics remain BLINDED as to what happened on a patient-by-patient basis. They themselves do not know because they have not physically seen the data. So to answer your question, quite bluntly: no, Frequency Therapeutics don't know what exactly has happened because they themselves haven't seen the data. That's why they said "we think...."

Similarly, we too are trying to make some educated guesses (thinking) as to what may have happened. Don't forget, the group level data from Phase 1/2 was not exactly compelling either at group level. What made the study so promising was the individual level analysis once one realised that out of the 6 patients who received FX-322 and had the headroom to improve their WR scores, ALL 6 improved. The devil is always in the detail.

Do you really think the 6 patients who improved in Phase 1/2 experienced a placebo effect? Two patients more than doubled their word scores and another two almost doubled their word scores and sustained these improvements over 12-18 months. Are you telling me all I have to do to have my life back and to quit this forum is to have a needle put through my eardrums?

Brb while I go stab myself in the ears.
 
There is definitely potentially a "we are about to insult many trial participants and want to thank people and not sound ungrateful" angle.

And @ajc, yes trials do get cancelled sometimes but those announcements are not vaguely tweeted first. If Frequency Therapeutics did that, I would definitely lose some respect for them.
Them blaming the patients without evidence was a horrible move. I know I did too, but it only took me a couple of days to figure out that they screwed up the entry criteria. A good trial accounts for desperation. Basically every drug, by definition, has people enrolling in desperation. They aren't victims here.

My personal belief is that they are pissed with themselves for not listening to their instincts of being conservative and keeping the bar low. All of their messaging was about hidden hearing loss and adjunctive therapy with hearing aids. After they got the results, they probably realized that they should have just done a rigorous Phase 1/2 repeat.

This has mismanagement written all over it. It's surprising too, as their team has impeccable track records.
 
@Olive27, now is a good time for you to stop posting in this thread. Being critical of others' comments is fine, but being so rude towards our most helpful and valued members is not acceptable.
 
I don't like how final this sounds... Have they given up on FX-322?

View attachment 44309
Okay, so I could be completely, utterly off base here. But this weirdly enough sounds like a scheduled tweet to me. I used to do social media for a startup and this is the kind of vague, pleasant nothing I would write months in advance for a scheduled release or drop. It's actually kind of eerie how similar it is in style to the stuff I'd write...

Again, I could be very wrong, but it just kind of pinged my old (and now derelict) social media radar. That they planned this as a thank you for the trial participants, and just dropped it in for some time near the end of March.

And given what we know from the press conference, it would go entirely against the statements made there. So either they were lying at the press conference to save face and had every intention to disband the trial, or this tweet doesn't really mean anything.

I'm leaning towards the latter, rather than the former.
 
Them blaming the patients without evidence was a horrible move. I know I did too, but it only took me a couple of days to figure out that they screwed up the entry criteria. A good trial accounts for desperation. Basically every drug, by definition, has people enrolling in desperation. They aren't victims here.

My personal belief is that they are pissed with themselves for not listening to their instincts of being conservative and keeping the bar low. All of their messaging was about hidden hearing loss and adjunctive therapy with hearing aids. After they got the results, they probably realized that they should have just done a rigorous Phase 1/2 repeat.

This has mismanagement written all over it. It's surprising too, as their team has impeccable track records.

In all fairness, they put it very, very delicately and we have simply read between the lines. We are the ones who have been throwing around the words "liars/fakers/cheaters" but the exact terminology used by Kevin Franck was very considerate and more suggestive towards an "unconscious bias" i.e. without intention. We are the ones who have suggested something more nefarious may have happened. Either way, the result is the same (if true).
 
Okay, so I could be completely, utterly off base here. But this weirdly enough sounds like a scheduled tweet to me. I used to do social media for a startup and this is the kind of vague, pleasant nothing I would write months in advance for a scheduled release or drop. It's actually kind of eerie how similar it is in style to the stuff I'd write...

Again, I could be very wrong, but it just kind of pinged my old (and now derelict) social media radar. That they planned this as a thank you for the trial participants, and just dropped it in for some time near the end of March.

And given what we know from the press conference, it would go entirely against the statements made there. So either they were lying at the press conference to save face and had every intention to disband the trial, or this tweet doesn't really mean anything.

I'm leaning towards the latter, rather than the former.
What is interesting though is that the tweet in question was posted using "Twitter Web App", while many of their other tweets have been posted by "CoSchedule", which is more of a tool for scheduling tweets.

When you open an individual tweet, you can see the software used to post the tweet next to the timestamp of the tweet.
 
My personal belief is that they are pissed with themselves for not listening to their instincts of being conservative and keeping the bar low. All of their messaging was about hidden hearing loss and adjunctive therapy with hearing aids. After they got the results, they probably realized that they should have just done a rigorous Phase 1/2 repeat.

This has mismanagement written all over it. It's surprising too, as their team has impeccable track records.
Classic example of hubris.

There are other places on the internet where patients they need to enter their trials (and probably doctors too) are thinking this thing is dead wholesale, a scam, or are really frustrated. That's going to create a new hurdle for recruiting, trusting the product/science, getting new investments. I'm sure they are aware of this, and there's derivative pressure to start cleaning up.

Or, they're just packing it up and taking their toys home.

I have been in many meetings with firms, where there are managers that think, "WE JUST HAVE TO DO SOMETHING RIGHT NOW" when stuff doesn't go to plan. This could be another reaction to that awful call on Tuesday. Seems like they're playing 2:00min football right now.
 
Re: the tweet. I think it's possible that they are using "development" in the pharma speak way:

https://en.wikipedia.org/wiki/Drug_development

Which includes clinical trials.

Because otherwise, if they seriously just made a major announcement on Twitter with no press release to accompany it, I would be beyond floored. That would be 10/10 unprofessional imo.
 
What is interesting though is that the tweet in question was posted using "Twitter Web App", while many of their other tweets have been posted by "CoSchedule", which is more of a tool for scheduling tweets.

When you open an individual tweet, you can see the software used to post the tweet next to the timestamp of the tweet.
Ah, that makes sense. What I don't understand then is why they would say they would move forward with single doses for FX-322 specifically following the results of the preliminary readout, and then turn around and give a vague tweet that might imply they are done with FX-322 development.

Unless we're all feeling a bit scared, and have fallen into the trap of doom posting without cause. Honestly it might just be that.
 
OMG... What if that tweet is in response to Tinnitus Talk chatter this week? Maybe they're watching really close?

Ok...

To Mr. LeBel:
Please release more data from the Phase 1b Open Label Trial.

-Diesel
 
I do have a Ph.D. in math. I am a professional scientist.
I know just enough about your equations and models to not doubt you. It would take me a week of Sundays to attempt to get your results. I do have very severe tinnitus and severe mouth pain - other pain, but you are the man. I woke up late today shaking with mouth pain and headache.
 
In all fairness, they put it very, very delicately and we have simply read between the lines. We are the ones who have been throwing around the words "liars/fakers/cheaters" but the exact terminology used by Kevin Franck was very considerate and more suggestive towards an "unconscious bias" i.e. without intention. We are the ones who have suggested something more nefarious may have happened. Either way, the result is the same (if true).
In a way, that's almost worse, IMO. It's like they think they will easily pull the veil over everyone.

Here's the problem. They could have designed the trial in such a way that there would be incentive to be honest. Just as an example, and I'm simplifying the numbers. In actuality, it would depend on the number of applicants, etc.

But let's just say they said to themselves the following. We are using Thornton Raffin confidence intervals to measure changes in repeated word tests. Let's do the same thing to compare their >=6 month test to the screening test.

It's really important to us to get good data here, knowing that people are desperate and that there's social media buzz on top of our own messaging, that we want low word scores. Let's create a rigorous standard.

Let's actually bother to read the Thornton Raffin paper (instead of just grabbing numbers from the 95% table). Let's construct rigorous 80% confidence intervals (smaller error margins). You have to score (incentive!) within the 80% confidence interval of the score that you took before you even knew about the trials (so basically 0% chance of the >=6 month WR score being faked).

You may try your hardest and your second score may land outside of the 80% confidence interval. It's not fair, you're not a bad person, but we demand people who are good at producing good repeat data.

Notice that my strategy is bad-incentive proof. I could have all sorts of nefarious, desperate intentions. I am encouraged to score my best.

To make this even better, you could have this standard and not reveal it publicly. This way, there's a higher probability that the >=6 month score was achieved from trying their hardest.

Between this test being stable and the audiogram being stable, there would be essentially no worry about frauds.

The only thing I can think of that wouldn't be Frequency Therapeutics fault is if the patients didn't lie at screen, but were paranoid that if their baseline scores were too good, they would be kicked out. This is unlikely to be the case, and is easily fixed by just insisting to them that the motivation is to do your best throughout the trial.

I really hope they did do something like this, but just got burned. If I can think of it, they definitely can.
 
Re: the tweet. I think it's possible that they are using "development" in the pharma speak way:

https://en.wikipedia.org/wiki/Drug_development

Which includes clinical trials.

Because otherwise, if they seriously just made a major announcement on Twitter with no press release to accompany it, I would be beyond floored. That would be 10/10 unprofessional imo.
It's also possible they're keeping tabs on a hearing loss forum where the majority of members are throwing their patients under the bus. Word gets out pretty quickly.

Edit: @Diesel beat me to it.
 
Do you really think that could be the case?
Maybe, who knows. We have to wait for the full readout. The best case scenario is that many of the patients experience improvements after Day 90 for it to be salvage for Phase 2a like the 3 positive anecdotes. If that doesn't happen then we will be relying on the age-related and severe hearing loss trials. I hope Frequency Therapeutics can pull a rabbit out of the hat like the Alzheimer's drug.
 
It's also possible they're keeping tabs on a hearing loss forum where the majority of members are throwing their patients under the bus. Word gets out pretty quickly.

Edit: @Diesel beat me to it.
I'm not sure how much they really follow this forum, but there's no question they took a peak to follow the PR fallout.
 
It's also possible they're keeping tabs on a hearing loss forum where the majority of members are throwing their patients under the bus. Word gets out pretty quickly.

Edit: @Diesel beat me to it.
Ugh. I contributed to that for sure. I think in my effort to keep it simple and more clear in the back and forth, I used "fakers" for instance vs their phrasing which is way more nuanced "unconscious bias."
 
It only seems like numerology if you just aren't interested in why Word Scores could dramatically increase without corresponding audiogram changes.
Common sense beats going down technical rabbit-holes.

Common sense dictates that this project is going back to the drawing board.

Now, you may feel that this move is somehow unfair, but that's what seems most likely.
 
In a way, that's almost worse, IMO. It's like they think they will easily pull the veil over everyone.

Here's the problem. They could have designed the trial in such a way that there would be incentive to be honest. Just as an example, and I'm simplifying the numbers. In actuality, it would depend on the number of applicants, etc.

But let's just say they said to themselves the following. We are using Thornton Raffin confidence intervals to measure changes in repeated word tests. Let's do the same thing to compare their >=6 month test to the screening test.

It's really important to us to get good data here, knowing that people are desperate and that there's social media buzz on top of our own messaging, that we want low word scores. Let's create a rigorous standard.

Let's actually bother to read the Thornton Raffin paper (instead of just grabbing numbers from the 95% table). Let's construct rigorous 80% confidence intervals (smaller error margins). You have to score (incentive!) within the 80% confidence interval of the score that you took before you even knew about the trials (so basically 0% chance of the >=6 month WR score being faked).

You may try your hardest and your second score may land outside of the 80% confidence interval. It's not fair, you're not a bad person, but we demand people who are good at producing good repeat data.

Notice that my strategy is bad-incentive proof. I could have all sorts of nefarious, desperate intentions. I am encouraged to score my best.

To make this even better, you could have this standard and not reveal it publicly. This way, there's a higher probability that the >=6 month score was achieved from trying their hardest.

Between this test being stable and the audiogram being stable, there would be essentially no worry about frauds.

The only thing I can think of that wouldn't be Frequency Therapeutics fault is if the patients didn't lie at screen, but were paranoid that if their baseline scores were too good, they would be kicked out. This is unlikely to be the case, and is easily fixed by just insisting to them that the motivation is to do your best throughout the trial.

I really hope they did do something like this, but just got burned. If I can think of it, they definitely can.
You know, I really think you should send them an email outlining all this. I don't think it would do any harm.
 

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