According to the August presentation, there is "Significant enthusiasm amongst <Otolaryngology> community." So, I'm sure there is some awareness... however, greater reach and frequency of the messaging means new eyeballs on the firm and the clinical trials.
They all had the same dose in phase 1.
Maybe I'm misinterpreting something, but the study "Arms and Interventions" section indicates that there was a high dose group and a low dose group in Phase 1/2:
There definitely were two dose categories, a low dose and a high dose, in the initial Phase 1/2 trial.
Hmm... I agree it definitely distinguishes "high dose group" and "low dose group" but they never seem to parse that out in their results unless I missed something...
There was a low dose group and a high dose group in Phase 1/2. The high dose is being used for Phase 2a.
Have you been given a reason why you we're not wanted as a trial participant? It indicates to me that you must have actually been rejected because there was some reason or some factor that they didn't want you for outside of the criteria related to hearing.
I think that this is a conspiracy theory. There was a fair acceptance and idea that there would be some delay from fairly early on during this trial.
They said in their Fireside that they had a temporary pause in their enrollment but were still dosing and following already enrolled participants. Since they are following people for 5 months out, a small delay in enrollment leads to having to wait 5-6 months out from those enrolled later. It's totally feasible that that's what happened. No need for conspiracies to explain it.
It's a long one because Frequency is probably forecasting out to when they think a vaccine might be available to be safe. At the rate COVID-19 is going in America, it's liable to really slow things down for testing across the board. Might be better to have some Canadian testing sites in the future so if any global pandemic happens at least some movement can be made.
Just out of curiosity, what was your word score? If it was really bad, they may think there aren't enough support cells left to regenerate sufficient hearing.
I didn't know either until someone on this forum pointed it out. If you do a google search of `"high dose" site:frequencytx.com`, only 1 result comes back, and it doesn't give any useful information. I've read the same thing that d'Wooluf posted, but I can't find any outside documentation to back it up. I've also read that they went with the high dose for Phase 2a, but that's another thing I can't find any outside documentation on. I would be weary about believing anything without an outside source, as sometimes this forum can act like an echo chamber. Looking back through the thread, at one point people were saying the dose in Phase 2a would be higher than Phase I/II [1], but I can't find anything to back that up either.
That's a good point. I'd just assumed they were the same 4 that had word score improvements, but they never state that anywhere. One thing Carl said in the Goldman Sochs conference that was interesting was that there was a "ceiling" effect to improvement [2, timestamp: 11:34]. I wonder if people from the "mild" hearing loss group couldn't achieve statistical improvements in word score because their scores were already too high. Maybe it was people from this group that saw improvements at 8 kHz.
It's possible that they could've conducted the trial with fewer people, but this would almost certainly mean that an additional phase would be required prior to approval.
The ceiling effect is intuitive, if you already have near perfect word scores, it is hard to get an improvement.
It's highly likely it's the same 4 patients that had the word score improvements.
I think that a fair part of it comes down to the desire and need to show that the treatment has benefit or can show benefits during the trial. This doesn't mean it won't work for you, it simply says that in the trial scenario(s) you might not provide the necessary results to demonstrate effectiveness.
What did you mean by "I got 6 right but I needed 8"? Are you referring to word scores count?
Their exclusion criteria has listed over 70 dB as an exclusion from the start (it is on their clinicaltrials.gov page). I'm not sure why that specifically was the cut off but I doubt they would change their entire parameters (not sure they would even be allowed to since the trial as outlined is approved by the FDA before start) because of COVID-19 or other enrollment delays.
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