If I recall the podcast conversation accurately, they will push treatment to market as soon as it's approved and it can be approved on the basis of these study cohorts (obviously why they're doing them), and subsequent Phase 3. The idea is that it is simply easier to prove out on nascent cases.
Maybe, the volume has been high. Lots of people are clearly heading for the exit. Though then again, it could be a self fulfilling prophecy. Everyone is on edge, someone decides to sell out and other people see them do that and think they know something so they sell out too, and it creates a cascading effect. It could also be some shenanigans. Someone big sells a lot to trigger a sell off and then picks things up cheaply after everyone has panic sold. That would be kind of risky though.
The PGIC and TFI are different. The PGIC is not a primary marker of efficacy that Otonomy are using anyway. I would think it is HIGHLY unlikely you will see anything near a 60% clinically meaningful responder rate, given that they have included more chronic cases in this and an overall much larger cohort of patients.
Most probably I'm afraid. It feels like it's always the same with those "promising" tinnitus treatments. You get some hope and after a while it shows that the treatment has no effect and your hope is killed and you realise that you will have to live with this noise forever. I'm sorry if I'm pessimistic, but it sucks when the hope is killed over and over again.
I was about to argue with you that they're highly correlated, but that may not be the case. I looked up the data for the PGIC in Phase 1/2:
It's possible the placebo group had positive PGIC responders who had weak TFI scores. They don't tell us if the 40% non-unchanged participants were positive or negative. If negative, it could be that the slow release gel causes some irritation. That could dampen any placebo effect.
We shall see. I don't think there will be any difference between the subgroups.
One difference with the new technology versus the old:
Agreed. I've completely separated share price/performance from trial/pipeline data.
Yep. What's really important now is for peeps not to get screwed over again like some did buying FREQ stock the last time things hotted up round here prior to the publication of trial data.
Placebo effect, or even worse, someone saying something to pump the stock. Take anything you read online with a grain of salt. There were several good anecdotes about FX-322, and that flopped pretty hard (when compared to placebo).
@patorjk, it could be many things. I find it hard to believe that even big investors have knowledge or tip offs before the company has the data. Leak is not impossible, however, it is doubtful.
We all fear the same thing, what if we get our hopes up and get crushed? I do agree that everything is always a letdown with the hearing community.
It sounds like the higher dose trial did better, but the placebo effect was just too discouraging in the Phase 2 trial. I get the feeling we may be doomed until there's a better way of measuring tinnitus.
All of those could fail miserably, maybe with the exception of Dr. Shore, but it could also be yet another Lenire with an inflated 80% "success rate".
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