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Frequency Therapeutics — Hearing Loss Regeneration

#16,682
Tezcatlipoca said:
Well whatever the case, I do believe FX-322 will come to market. Trobalt did and it was as safe as rat poison.
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I think FX-322 will come out to the market as well. If the next set of Phase 1b trials show meaningful improvements, then best case scenario is they can go to the pivotal phase early next year. If not, then I hope the Phase 2a trials are shorter so they can still meet the target of 2023.
 
#16,683
FGG said:
I never had to speak to a central person. As far as I know only the local site was involved with at least my screening.

If it helps, she had a list that she appeared to refer to (that i couldn't see). I do know i was her very first fx-322 applicant because she told me.
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I think what remains unclear though, and I believe this is what Diesel was trying to get at, is who decides whether you get into the trial or not if the centre has screened you to meet the criteria of the trial? Say your audiogram was sufficient, the assessor would have then presumably done another audiogram to confirm. At that point, does the centre have some authority to enter you into the trial without answering back to Frequency Therapeutics, or do they then have to relay the data, either to Frequency Therapeutics or some independent reviewer (FDA?) to confirm?
Diesel said:
So, help me understand the screening process? Does a central person at Frequency Therapeutics approve the applicants sitting in the screen queue to enter the trial? Or does a central independent screener review the applicants in the queue, and then approve those that meet Frequency Therapeutics' requirements?

I assume it is central because they're meeting a quota, so some type of centralization has to take place to report on the recruiting progress. Am I correct on this assumption?

If so, I am wondering if there isn't enough evidence to support the faker/liar theory, perhaps there was an ongoing error administering the screening process.
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Following on from what I said above, I'm not sure if it really matters if Frequency Therapeutics or someone else is reviewing the screened applicants. At the end of the day, each applicant will have had to have fallen within Frequency Therapeutics' criteria and the screener at the centre would, presumably, not allow someone to proceed if there's some kind of discrepancy between their records and the tests at screening. I would imagine - and I'm only guessing here - that Frequency Therapeutics' only role at this point would be to accept/deny patients on the basis of severity recruitment profile e.g. "we've already got enough mild patients so we're going to reject the mild patients from this centre and accept the moderate/severe ones". Assuming some reviewer, be it Frequency Therapeutics or some independent, did check the screening tests against historical records, I can't see how they would allow a mismatch to occur and let that patient take part in the trial.

All this to say, quite simply, that I don't see how it was possible for there to be any mismatch between historical records and screening test. The only mismatch of the kind Frequency Therapeutics have alluded to would have had to have been between baseline (where they are blinded) and the screening tests/historical records combined. The problem I have with this, as @Zugzug as aptly pointed out in his game theory explanation, is that there is no rational incentive to do this. Once you are in the trial, you have no reason to tank your score. If anything, you are more likely to tank your score BEFORE you get into the trial, not after. I also don't buy the patients tanking their score to show effect to get the drug to market either. @Zugzug captured this perfectly:

"Say I made it into the trial. It doesn't matter how; I'm in. There's a 75% chance I will be treated and a 25% chance I won't.​

If I reasoned to myself that "I'm going to tank my baselines," there are two reasons why I might be thinking this -- both are stupid. One might be to stay consistent with low screening and the other might be "there's a 75% chance that I'm in the FX-322 group. If I perform low at baseline and then crush the tests with treatment, I have a chance of helping the drug clear the finish line."​

For the first one, there's no real motivation to stay consistent; one can't prove it or punish them. For the second one, it doesn't make sense because if they believed they were in the treatment group, they wouldn't have the same motivation for getting the drug through because they thought they were already receiving it.​

If they then asked themselves "what if I'm in the placebo group?" then they wouldn't want to inflate placebo improvements, reducing the chances of eventually receiving the actual drug someday."​

But @Zugzug also said some people don't think rationally. I'm not that old to say I'm wise, but I'm old enough to know this is very true.
 
#16,685
Joe72 said:
Allow me to take a stab at the reason - billions of dollars on a recurring global annual basis for "vaccines" vs a tiny % of the population that suffers from tinnitus that is difficult to measure and can manifest itself from a hundred different causes.

Hmmm... sounds like Big Money wins again. And again. And again. Sucks, but it's true.
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A "tiny" percentage of the population does not have hearing loss; a large portion does. FX-322 is a drug to reverse hearing loss, not cure tinnitus.
 
#16,687
Tezcatlipoca said:
Well whatever the case, I do believe FX-322 will come to market. Trobalt did and it was as safe as rat poison.

And as far as I know they never had Fast Track designation.
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FX-322 still hasn't got Breakthrough Therapy status, but with many trials with the single dosing of FX-322 it may still be possible to get it since they have over 100 candidates from the Phase 1b trials that shows it was safe and effective.
 
#16,688
Tezcatlipoca said:
Well whatever the case, I do believe FX-322 will come to market. Trobalt did and it was as safe as rat poison.

And as far as I know they never had Fast Track designation.
Click to expand...
The safety profile certainly helps. Especially if they didn't have any serious adverse events or dropouts after overdosing patients with 4 injections of the stuff in the Phase 2A. Particularly if these patients turned out to have good hearing (from faking), and it didn't make it worse.

I suspect that there may be one more pivot from the firm, which may piss a lot of people off. Even though they've been "accepting" Mild-Severe SNHL patients into the trial, if the Severe Phase 1B trial shows safety + the most efficacious outcomes; I could see them pivoting to a Phase 2B for Moderately-Severe + Severe SNHL, and the pivotal for the same subset.

These two groups stand to be the most reliable patients and responders, and gives them the 'safest' path to what may end up being the most responsive patient population.
 
#16,691
Aaron91 said:
I've had a reply from a second patient who took part in the trial.

As you'll recall, the first patient I found was quite positive about their experience. This one not so much. Here's what they had to say in their own words:

"Hello Aaron- I have not read the interim analysis. I should do that. But I am not surprised that it isn't encouraging. I have noticed no improvement at all since doing the trial. My word recognition went up a tiny bit but honestly, I think that's because I got better at taking that test. I did it so many times and it caused me a lot of anxiety at first. I got calmer about it after a while. And more willing to guess at the words I was hearing, so I think that gave me a better chance. But the improvement was incredibly minimal, and not clinically relevant. Or so I was told. I had a lot of hope when I was accepted into this trial and it was so disappointing to get nothing from it. But of course there is a chance that I got the placebo. As soon as I learn anything concrete about that I will definitely share.​

I went to ask some follow-up questions about the testing methods. Again, here's what they had to say in their own words:

"The word test was not exactly the same each time, although I think they had 2 or 3 versions and there was definitely repetition. So maybe I memorized some things. I was told to go ahead and guess. Sometimes it was only a vague vowel sound I could hear, so it was so much a guess as just making stuff up! I'm glad you heard from someone who saw improvement from the trial. I actually hope that I DID get the placebo since nothing changed. Gives me hope of getting the real thing down the road."​

As for the speculation surrounding the "burning" experienced by the other patient during 2/4 injections, again this is what the second patient had to say:

"For me, the injections were incredibly painful. All four of them. Yes, I would say it was a burning sensation. I was told that they would not be painful, but even with numbing medication first it was awful. The doctor was pretty surprised by that as he was sure I would not really feel it at all."
​
When I mentioned to them that some other patients may have purposely or subconsciously tanked their WR scores, here's what they had to say:

"Wow! It wouldn't have occurred to me to do that!"
​
The thing I was most curious about was whether Frequency Therapeutics had been in touch with the patient since the trial and asked for any further historical records. They haven't. The only record they gave Frequency Therapeutics was during screening:

"Sorry - what I said wasn't clear. To get into the trial in the first place I had to submit my most recent audiogram. I had one from an ENT that was incomplete and at first they rejected me. Then I sent them one from an otolaryngologist that showed more detail and they said I was perfect fit based on that one."
​

This was very interesting to me. Frequency Therapeutics seemed to imply in the conference call that there was a mismatch between the historical records and baselines (not screenings). That made me wonder: were the screening tests used as baseline? The first patient has come back to me and said that wasn't the case: there was a hearing test to screen the patient after submission of previous records, and then a new baseline was taken before the first injection. So that got me really confused, because if the whole incentive to tank a word score is to get into the trial, why would a patient keep a consistent score between their historical record and screening and then tank their score only once they're in the trial? Makes no sense at all. The only explanation I had was that word scores were not used as historical records, only audiograms. I've gone back to confirm this with both patients, but judging from what the patient said above, it would seem they only had to submit their audiogram. Can someone here who applied to get in confirm?

If this is the case, this is even more perplexing. How could Frequency Therapeutics claim there's a mismatch between historical records and baselines if no historical word recognition scores were provided in the first place and Frequency Therapeutics haven't since gone back to ask if they had any more records? The only assumption I can make is they're claiming there's a mismatch between the historical audiograms and the baseline audiograms and assuming the same of the WR scores, but that isn't possible because the incentive to tank is at screening, not once you're in the trial.

Something doesn't add up here. I must be missing something. Help?

Edit: the first patient has since come back and confirmed they had to submit both a WR score and audiogram.

Edit 2: this still isn't making sense. How could there be a mismatch between baseline and historical records if the whole point of screening is to prevent this in the first place? Is it possible that the very opposite happened to what we thought? Did patients go their doctors, fake their WR score and audiogram to apply to get in, did it again at screening, and then performed normally at baseline? Even this would seem a stretch.
Click to expand...
Thank you for your valuable interview.

Why this patient didn't improve...

・ Placebo 4 times.
・ FX-322 4 times, but this medicine has no effect.
・ FX-322 4 times, but the effect was inhibited by short-term intensive injection.
・ FX-322 4 times, but the hair cells in this patient are not the cause of hearing loss.
・ Other causes

What could be the cause?
 
#16,692
Aaron91 said:
I think what remains unclear though, and I believe this is what Diesel was trying to get at, is who decides whether you get into the trial or not if the centre has screened you to meet the criteria of the trial? Say your audiogram was sufficient, the assessor would have then presumably done another audiogram to confirm. At that point, does the centre have some authority to enter you into the trial without answering back to Frequency Therapeutics, or do they then have to relay the data, either to Frequency Therapeutics or some independent reviewer (FDA?) to confirm?

Following on from what I said above, I'm not sure if it really matters if Frequency Therapeutics or someone else is reviewing the screened applicants. At the end of the day, each applicant will have had to have fallen within Frequency Therapeutics' criteria and the screener at the centre would, presumably, not allow someone to proceed if there's some kind of discrepancy between their records and the tests at screening. I would imagine - and I'm only guessing here - that Frequency Therapeutics' only role at this point would be to accept/deny patients on the basis of severity recruitment profile e.g. "we've already got enough mild patients so we're going to reject the mild patients from this centre and accept the moderate/severe ones". Assuming some reviewer, be it Frequency Therapeutics or some independent, did check the screening tests against historical records, I can't see how they would allow a mismatch to occur and let that patient take part in the trial.

All this to say, quite simply, that I don't see how it was possible for there to be any mismatch between historical records and screening test. The only mismatch of the kind Frequency Therapeutics have alluded to would have had to have been between baseline (where they are blinded) and the screening tests/historical records combined. The problem I have with this, as @Zugzug as aptly pointed out in his game theory explanation, is that there is no rational incentive to do this. Once you are in the trial, you have no reason to tank your score. If anything, you are more likely to tank your score BEFORE you get into the trial, not after. I also don't buy the patients tanking their score to show effect to get the drug to market either. @Zugzug captured this perfectly:

"Say I made it into the trial. It doesn't matter how; I'm in. There's a 75% chance I will be treated and a 25% chance I won't.​

If I reasoned to myself that "I'm going to tank my baselines," there are two reasons why I might be thinking this -- both are stupid. One might be to stay consistent with low screening and the other might be "there's a 75% chance that I'm in the FX-322 group. If I perform low at baseline and then crush the tests with treatment, I have a chance of helping the drug clear the finish line."​

For the first one, there's no real motivation to stay consistent; one can't prove it or punish them. For the second one, it doesn't make sense because if they believed they were in the treatment group, they wouldn't have the same motivation for getting the drug through because they thought they were already receiving it.​

If they then asked themselves "what if I'm in the placebo group?" then they wouldn't want to inflate placebo improvements, reducing the chances of eventually receiving the actual drug someday."​

But @Zugzug also said some people don't think rationally. I'm not that old to say I'm wise, but I'm old enough to know this is very true.
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What I was saying was for the screen (which I needed two standard audiograms only for to assess stability), I'm not sure whether or not my word score would be used or if we would just take a new baseline. We didn't talk about my word score at all but she went over my audiogram (saying it was consistent at least).

If I was approved, I was to see their audiologist that day but I wasn't. They didn't have my full medical records at that point but I signed paperwork saying they could request them (this is a standard US practice between medical providers). From experience, these requests never go through immediately that day or even that week, usually.

So what I'm saying is, they would have gotten my baseline before having access to my full records. I'm not even sure at what point my full records would have been looked at. It's possible it would only have been scanned for certain things (sudden hearing loss, etc) or maybe not looked at before data. I really don't know.

It occurred to me it's also possible, since I don't believe word scores were ever mentioned as something to bring with me to the appointment unlike audiograms (maybe someone else who applied can confirm this), that maybe they only used the baseline from that day.

I.e. if your audiograms passed, they got the baseline WS that day? Was the word score "screening" done as baseline?
 
#16,693
I have a couple of bear points. I want to reiterate that I think the impact of cheating was minimal, but I want to add the following:

Bear Thesis 1: Game theory: Cheaters should help the treatment group more.

Think of like this. I cheat my way into the study somehow. At baseline, I tank my word scores, but my whole motivation was desperation to get the drug as soon as possible. Here's how my scenarios break down.

Case 1, I think I got FX-322 and I did: Then obviously, I have two things that will boost my score over time. The one is that I am no longer lowering my score by cheating. The other is that I legitimately believe the drug is helping my hearing and want to show it off.

End result: Big help to treatment group.

Case 2, I think I got FX-322, but I got the placebo: If this is the case, it would mean the placebo itself gave me reason to believe my hearing was improving.

End result: Hearing is harder to measure than we realize, if someone in a placebo group could think they were treated.

Case 3, I think I got placebo, but got FX-322:

End result: The drug did so little for me that I thought I got a placebo.

Case 4, I think I got placebo and I did:

End result: Then all cheating just neutralizes. I cheated to get in, but now that I'm in, I understand that I'm probably in the placebo group so shouldn't inflate the scores. Unlike case 3, I am correct. I tank after and at baseline, hurting the placebo gains. In other words, selfish reasons encouraged me to cheat from the start, but selfish reasons encouraged me to cheat to hurt the placebos afterwards.

As we can see, there are reasons in all 4 situations (which account for all possibilities) that either the drug looks bad or the cheating doesn't hurt the drug's success in the trial.

A hole that I'm going to stop now: "Oh, Zugzug. No one runs their life by a game theory matrix like that. Come on."

Rebuttal: Okay, but they are smart enough to cheat their way into the trial? Have the forethought to fake word scores far in advance? They somehow outright lie about hearing a word during the baseline test, but they are above this?
---------------------------------
Bear Thesis 2: Placebo Effect on WR test is underrated (no cheaters involved)

Okay, let me be delicate about this because if I'm not, I'll look like an ignorant moron. I am not suggesting that a placebo effect can help someone hear words (other than 1 or 2 here and there).

However, WR is a test. It's not living with this condition for months and having millions of data points. It's also scored in a binary way. This is a huge flaw. Maybe there really is an innocent unconscious bias aspect. What I mean here is maybe at the screen, they never lie, but if they can't make out a word, they don't even take random stabs.

For example, if the word "mew" is played and it's muffled to the point where they lack close to 100% confidence, maybe due to motivation to get into the trial, they just say "not sure."

Then maybe after baseline, when they test again, they guess. Maybe they say "new" or "moo". Of course, can someone really double their correct word scores in this way? Almost surely not. But it does provide a fixed improvement effect for all groups. It is consistent with "unconscious bias" and is consistent with their claims that all groups improved.

Final thing to add to this thesis: If I take the test in a situation where it doesn't get me in or not get me in, my likelihood of guessing or saying "I don't know" will almost be dependent on my personality type as opposed to my intentions.

Even just in psychology, some people (myself) try really hard on tests, while others give up if they don't know.
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These thesis points still don't address super responders. They really only address whether we should have reason to believe that Phase 2a could have been a success without the few cheaters.

The story that @Aaron91 just shared adds credence to bear thesis 2. Notice that the person felt more comfortable with guessing and improved their score a little bit. This totally makes sense, as guessing could help the score, but not lead to statistical significance. This is precisely what happened. A widespread pattern of this phenomena largely explains why all groups somehow improved.
 
#16,695
kiki said:
Thank you for your valuable interview.

Why this patient didn't improve...

・ Placebo 4 times.
・ FX-322 4 times, but this medicine has no effect.
・ FX-322 4 times, but the effect was inhibited by short-term intensive injection.
・ FX-322 4 times, but the hair cells in this patient are not the cause of hearing loss.
・ Other causes

What could be the cause?
Click to expand...
Well Frequency Therapeutics has said that the more drug, the worse outcomes compared to the single arm. If that holds up, then first or third option.
 
#16,696
@Aaron91, the patient that had a positive anecdote, did he experience the burning sensation with the first 2 shots or the last 2 shots?

I remember you said that they always inject FX-322 first before the placebo. If we find out when he experienced the burning sensation, then we will know if it was FX-322 or placebo.
 
#16,697
Aaron91 said:
I think what remains unclear though, and I believe this is what Diesel was trying to get at, is who decides whether you get into the trial or not if the centre has screened you to meet the criteria of the trial? Say your audiogram was sufficient, the assessor would have then presumably done another audiogram to confirm. At that point, does the centre have some authority to enter you into the trial without answering back to Frequency Therapeutics, or do they then have to relay the data, either to Frequency Therapeutics or some independent reviewer (FDA?) to confirm?
Click to expand...
My take on the screening business:

While audiogram and WR are different tests, they commonly are tested at the same time. For example, I have one sheet that has both on it.

Since WR is not a part of the inclusion criteria, I bet they still looked at it if it was there. They probably excluded people for glaring situations, but somewhat unscientific. In other words, they didn't say, let me pull out the Thornton Raffin confidence intervals. It was probably more like, "well they qualify, but what is this? 50% and then 95%?"

I can't imagine they didn't have something like that in place at the very least. It's obviously still a blunder.
 
#16,698
FGG said:
I think it's fair to say they believed the results would be good.
Click to expand...
They probably didn't realise that multi-dosing was going to be a problem. I don't think they had the intention to fake about FX-322. When they saw that the Phase 1b trial showed improvements, they probably thought multi-dosing weekly will make it more effective but it turned out wrong.

I really hope this does not delay things too much. If they continue with the single dosing of FX-322, the trials should be much quicker.
 
#16,699
Zugzug said:
I have a couple of bear points. I want to reiterate that I think the impact of cheating was minimal, but I want to add the following:

Bear Thesis 1: Game theory: Cheaters should help the treatment group more.

Think of like this. I cheat my way into the study somehow. At baseline, I tank my word scores, but my whole motivation was desperation to get the drug as soon as possible. Here's how my scenarios break down.

Case 1, I think I got FX-322 and I did: Then obviously, I have two things that will boost my score over time. The one is that I am no longer lowering my score by cheating. The other is that I legitimately believe the drug is helping my hearing and want to show it off.

End result: Big help to treatment group.

Case 2, I think I got FX-322, but I got the placebo: If this is the case, it would mean the placebo itself gave me reason to believe my hearing was improving.

End result: Hearing is harder to measure than we realize, if someone in a placebo group could think they were treated.

Case 3, I think I got placebo, but got FX-322:

End result: The drug did so little for me that I thought I got a placebo.

Case 4, I think I got placebo and I did:

End result: Then all cheating just neutralizes. I cheated to get in, but now that I'm in, I understand that I'm probably in the placebo group so shouldn't inflate the scores. Unlike case 3, I am correct. I tank after and at baseline, hurting the placebo gains. In other words, selfish reasons encouraged me to cheat from the start, but selfish reasons encouraged me to cheat to hurt the placebos afterwards.

As we can see, there are reasons in all 4 situations (which account for all possibilities) that either the drug looks bad or the cheating doesn't hurt the drug's success in the trial.

A hole that I'm going to stop now: "Oh, Zugzug. No one runs their life by a game theory matrix like that. Come on."

Rebuttal: Okay, but they are smart enough to cheat their way into the trial? Have the forethought to fake word scores far in advance? They somehow outright lie about hearing a word during the baseline test, but they are above this?
---------------------------------
Bear Thesis 2: Placebo Effect on WR test is underrated (no cheaters involved)

Okay, let me be delicate about this because if I'm not, I'll look like an ignorant moron. I am not suggesting that a placebo effect can help someone hear words (other than 1 or 2 here and there).

However, WR is a test. It's not living with this condition for months and having millions of data points. It's also scored in a binary way. This is a huge flaw. Maybe there really is an innocent unconscious bias aspect. What I mean here is maybe at the screen, they never lie, but if they can't make out a word, they don't even take random stabs.

For example, if the word "mew" is played and it's muffled to the point where they lack close to 100% confidence, maybe due to motivation to get into the trial, they just say "not sure."

Then maybe after baseline, when they test again, they guess. Maybe they say "new" or "moo". Of course, can someone really double their correct word scores in this way? Almost surely not. But it does provide a fixed improvement effect for all groups. It is consistent with "unconscious bias" and is consistent with their claims that all groups improved.

Final thing to add to this thesis: If I take the test in a situation where it doesn't get me in or not get me in, my likelihood of guessing or saying "I don't know" will almost be dependent on my personality type as opposed to my intentions.

Even just in psychology, some people (myself) try really hard on tests, while others give up if they don't know.
-------------------------------------------------------------------
These thesis points still don't address super responders. They really only address whether we should have reason to believe that Phase 2a could have been a success without the few cheaters.

The story that @Aaron91 just shared adds credence to bear thesis 2. Notice that the person felt more comfortable with guessing and improved their score a little bit. This totally makes sense, as guessing could help the score, but not lead to statistical significance. This is precisely what happened. A widespread pattern of this phenomena largely explains why all groups somehow improved.
Click to expand...
Nice work. Here's the thing... how do you think the makeup of the Consonant-Nucleus-Consonant Word Lists used in the Word Recognition Test may have played a factor? It seems like many are overlooking the makeup of the test itself. There's been a few discussions on how people think the "just memorized it" and that's how they did better. Based on my understanding of the setup of the lists, and that there are 10 lists of 50 that are commonly used, I don't buy it that anyone is memorizing lists and regurgitating anything from memory between a 30-day time period. Also, if they truly did have poor hearing going into the Phase 2A, or any phase for that matter, how could they have possibly memorized words that they didn't hear accurately the first time, or words that they starting hearing accurately because of the treatment, but heard incorrectly prior?

Link:
An Examination of Sources of Variability Across the Consonant-Nucleus-Consonant Test in Cochlear Implant Listeners
 
#16,700
FGG said:
It occurred to me it's also possible, since I don't believe word scores were ever mentioned as something to bring with me to the appointment unlike audiograms (maybe someone else who applied can confirm this), that maybe they only used the baseline from that day.

I.e. if your audiograms passed, they got the baseline WS that day? Was the word score "screening" done as baseline?
Click to expand...
From having spoken to a patient from the trial, no. The patient told me they presented a WR score and audiogram at their appointment. At the same appointment, they went for a screening test and re-did those same tests. After being accepted into the trial, they did the tests a third time before they even had their first injection, which I can only presume was the "baseline" test. To put it simply, Frequency Therapeutics have three points in time to glean from before any patient in the trial has had their first injection. That's why I said in my previous posts it would have been impossible for the medical records to have been substantially different from the screening test but possible for the medical records/screening test to have been different from baseline given Frequency Therapeutics at that point blinded themselves.

To your point, you're saying that there may have been a lag between the assessors doing their screening test and them obtaining any further historical records. I suppose where we all may be getting confused is what Frequency Therapeutics mean when they say "historical records". Do they mean the tests patients brought along with them to the initial appointment, or tests from before? Are they suggesting, possibly, that the test scores patients brought to their appointment were way different than their previous ones? As I said, I don't think this is possible either, because both patients I spoke to said Frequency Therapeutics hasn't since asked them for further medical records other than the ones they brought with them to the initial appointment. Would some people have taken more records than required to their initial appointment? Who knows.

I completely understand the motivation to tank a word score to get into the trial, but to do this successfully you have to tank your score twice: once before your initial appointment and once again at screening. My whole point is that that is what Frequency Therapeutics' thesis hinges on. Say you're a patient that does this successfully, once you're in the trial, you have no motive to tank your score again, other than to stay consistent. So if you perform as normal, your baseline is already miles above what Frequency Therapeutics had expected it to be, regardless of what group you've landed in. Even if you get FX-322, chances are it won't do much for you because you're closer to the ceiling than Frequency Therapeutics would have liked, never mind the fact multiple doses probably makes things worse. Alternatively, if you decide to tank your score again at baseline in the interests of staying consistent, your score is going to increase regardless of whether you get placebo or FX-322, because at that point you certainly have no reason to tank.

I just think the whole thing is a mess.
 
#16,702
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#16,703
Aaron91 said:
From having spoken to a patient from the trial, no. The patient told me they presented a WR score and audiogram at their appointment. At the same appointment, they went for a screening test and re-did those same tests. After being accepted into the trial, they did the tests a third time before they even had their first injection, which I can only presume was the "baseline" test. To put it simply, Frequency Therapeutics have three points in time to glean from before any patient in the trial has had their first injection. That's why I said in my previous posts it would have been impossible for the medical records to have been substantially different from the screening test but possible for the medical records/screening test to have been different from baseline given Frequency Therapeutics at that point blinded themselves.

To your point, you're saying that there may have been a lag between the assessors doing their screening test and them obtaining any further historical records. I suppose where we all may be getting confused is what Frequency Therapeutics mean when they say "historical records". Do they mean the tests patients brought along with them to the initial appointment, or tests from before? Are they suggesting, possibly, that the test scores patients brought to their appointment were way different than their previous ones? As I said, I don't think this is possible either, because both patients I spoke to said Frequency Therapeutics hasn't since asked them for further medical records other than the ones they brought with them to the initial appointment. Would some people have taken more records than required to their initial appointment? Who knows.

I completely understand the motivation to tank a word score to get into the trial, but to do this successfully you have to tank your score twice: once before your initial appointment and once again at screening. My whole point is that that is what Frequency Therapeutics' thesis hinges on. Say you're a patient that does this successfully, once you're in the trial, you have no motive to tank your score again, other than to stay consistent. So if you perform as normal, your baseline is already miles above what Frequency Therapeutics had expected it to be, regardless of what group you've landed in. Even if you get FX-322, chances are it won't do much for you because you're closer to the ceiling than Frequency Therapeutics would have liked, never mind the fact multiple doses probably makes things worse. Alternatively, if you decide to tank your score again at baseline in the interests of staying consistent, your score is going to increase regardless of whether you get placebo or FX-322, because at that point you certainly have no reason to tank.

I just think the whole thing is a mess.
Click to expand...
Some people do request their full medical records in advance of new doctors' appointments of any kind. Personally, I hadn't done that before screening and it wasn't required.
 
#16,705
Gb3 said:
View attachment 44318

View attachment 44319
Click to expand...
Interesting in a positive way... but also interesting that someone with hearing loss doesn't know how to read their own audiogram. Is it a bull or bear thesis that enough "smart" people figured out how to outsmart the filter, and therefore screeners unknowingly selected the smart scammers and rejected the honest folk.
 
#16,707
Yeah the way I see this, is that multiple dosing is likely the reason for the fail, assuming the first phase wasn't a scam.

I think the chances that fakers could have tanked the test so badly is very small.

So I think that they will pursue the 1 shot dose, confirm that the first phase wasn't a fluke and that 1 shot does indeed boost word scores and 8,000 Hz and above. We will have something that can take the edge off high pitched tinnitus by 2025.

The drug is not dead. A lot of us weren't expecting anything drastic from multiple dosages but we at least figured it wouldn't hurt. Chemistry is a fickle thing and something like multiple dosages could throw off the ratio of various molecules which could render the medicine useless. Placebo junk mixing with the real drug in the ear could even screw it up. In retrospect, it was kind of arrogant to assume the ear could just take all that fluid being pumped in the ear and it not go wrong.

Hitting lower frequencies is likely still several years away but I think there's something for the high frequencies right now.
 
#16,709
Diesel said:
Interesting in a positive way... but also interesting that someone with hearing loss doesn't know how to read their own audiogram. Is it a bull or bear thesis that enough "smart" people figured out how to outsmart the filter, and therefore screeners unknowingly selected the smart scammers and rejected the honest folk.
Click to expand...
I read that different. It sounded like they thought the asker didn't understand audiograms and they just explained it poorly to them.
 

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