He's probably making $500k a year too and had no clue what tinnitus was 2 years ago. That's why the rich should have the shit taxed out of them. Well maybe not if they are a business owner.
which requires the submission of "basic results" for certain clinical trials, generally no later than 1 year after their Completion Date
Think that's a mistake, @AfroSnowman.
I guess I read this as publication in 2023. I would think, knowing nothing about it, that they would unblind as soon as the study is over, because what reason could she have not to?
Thanks very much for pursuing this as far as you can, @Uklawyer and @AfroSnowman.
Tell that to the people who died for lack of a cure because they couldn't stand one more minute of torture. Tell that to those who are living in hell every second of their life and don't have the strength to carry on one more week or month. Sense of entitlement? What the hell are you talking about? What do you think these extreme cases are doing? Drinking beer and playing bridge while being moderately curious about the results? Some of these people have children they can't attend to anymore, families are destroyed. There are people living in hells you don't even imagine. Of course the Auricle and University of Michigan people can care zero about it, but why should we keep silent about it? Please. If that CEO email isn't a masterpiece of corporate @#@#%&-speak I don't know what is. It didn't explain anything. He doesn't owe us any explanation (well unless the research was partly funded with tax money) but then say it clearly you don't care, don't send that masterpiece email. "Deal with it". Sheees.
Super possible that will be the case, but that seems a pretty extreme take at this point. I imagine that maybe it has just been unblinded or maybe it is yet to be and will be in a week or two. I'd give her/them a month or two to analyze and understand a study that is likely the culmination of decades of research before making any kind of public comment.
Shore's device is not for me, but this is bullshit. Some people are literally on the verge.
I'm calling BS on that excuse. Why did Dr. Shore release data on the preliminary trial of 20 people if that would risk regulatory filing/FDA approval? Why did Lenire release papers with results of their multiple trials, but are now in the process of obtaining FDA approval? Lenire is going to be approved by FDA before Shore's team can even create a spreadsheet to compile data. Entitlement. No. Just don't believe their exceedingly excuses anymore.
Erm, sorry to state the obvious, but the results are the results. 400 people, quantitative feedback using a couple of scales. Essentially all unblinding has been done. Data would have been set out at various points of the study and double-checked. The final data point needed to be completed. Plus unblinding.
Why not do some research into the regulatory process and the risks before assuming they don't exist? Why not assume it's proceeding and hope for the best?
We did have an expert on the FDA approval process.
This is the standard timeline for trials of this type. Check out the very impressive commentary in the rest of his post. He sure seems to know what he is talking about.
I've come to expect regular attempts to tone-police from Tinnitus Talk threads such as this.
It's like that on every forum and every social network... It's how humans evolved to communicate...
Hmmm... I've heard a different story from Dr. De Ridder in my exchange with him. Interesting.
The TU Delft device and Auricle are both bimodal stimulation devices.
Yes.
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