Am I reading it right that she insists the peer review preceeds the FDA submission? This will waste a lot of time. Put the results in a bloody preprint, as many researchers do, especially those funded by grants coming from taxpayer money, and submit that to the FDA, and then in parallel submit to a journal for peer review.
I'm sorry to say this but, at this point, if De Ridder came out earlier than Shore with a device that works and stole her market it would be poetic justice. I don't think he can be that fast, though, and to commercialize it in the US he would need to engage the FDA. However, if the device is almost ready and he doesn't care about a journal publication before the approval, he could beat Shore even in the US in terms of timing, as journal publications can take years in the worst cases.
Don't think he can beat her for an FDA approval but 100% he will be faster to start treatments in Europe than Auricle. Remember that in the EU, without any required approval, he can theoretically start tomorrow with compassionate use if he has a number of devices to use. No trials needed. Just like he provides/provided all kind of other experimental, non-"approved" treatments.
This is why YOU GUYS SHOULD HAVE STOPPED BOTHERING THEM. I knew this was going to happen. Trust me, if they wanted us to know they would have let us known.
Not sure where this comes from. The FDA process and the academic process proceed in parallel, but the FDA process determines when information can be disclosed and published. I think this research has preceded remarkably on schedule considering the challenges COVID-19 presented for clinical trials. Of course, we all would've liked a treatment a long time ago. Dr. Shore is commenting on the scientific process and the Auricle CEO is talking about the commercialization process. They are working in tandem.
Please explain, otherwise it seems like just name calling.
That is not name calling. I did not call Dr. Shore a "name".
This is an empty statement. This states nothing about requirements to publish in a medical journal (or the constraints to which Dr. Shore refers). I strongly suspect that there is no such requirement. This is simply a statement of intention. It provides zero information of value to the public around delay in publishing results. It is a non-sequitur.
Do you mean the "first" and "second" in the statement are not meant as a temporal and/or priority order? Jointly with her previous emails and the CEO one (super-evasive) this was my impression.
But it really does not matter what you think. Or are you going to send an email to change her mind, when she just asked to STFU and let her work?
Even if she could have done it your way (I'm not sure about that), she and Jon Pearson have decided on a different approach. Respect that and be grateful someone wants to research and treat this torture. Some of it being paid for by taxpayer money has zero relevance, it's not like she's doing anything untoward. I feel bad for her honestly. The self-righteousness... 
Perhaps it does not matter to you, but it can make a life/death difference to other people. You are the one who started the VAD thread, of all people you should know the urgency of this.But it really does not matter what you think. Or are you going to send an email to change her mind, when she just asked to STFU and let her work?
Yeah, kind of like fusion where no matter what year it is, it's always going to roll out 20 years in the future.
I remember similar sentiments about team-Neuromod vs. team-Shore prior to Lenire's release with many jumping on the Neuromod bandwagon based on them seeming to move at lightspeed vs. Shore's snail's pace and we saw how that one turned out.
Thank you for this. Medicine is not my field, as I said. I will read this. However, I feel some points I made on the priority in their press release and on the vagueness of their emails and press release still stand. And if the FDA is so rigorous, how is it that they approved devices like DeSyncra? This is totally at odds with this great rigor you mention, unless they have strongly tightened their criteria since then. But I'll read the documents.
Yeah, my statement was subordinated on De Ridder having his own clinical trial in TU Delft and having made things rigorously. I don't think that will be fast enough to overtake Shore.
I assume you are talking to me (there is a quote button). Please don't put words in my mouth. I never said she is milking it. I take exception to the vagueness of their statements and to the priorities in those statements. And I brought up the government funding to point out they are not exempted from enquiries. Does this mean they have to satisfy every whim of every taxpayer? Of course not, but the opposite attitude of not caring at all because cancer etc would lead you to a slippery slope where any discussion on how public money is spent should be censored. I don't think that's a good idea. And I'm not saying, and never said, that they haven't worked hard or diligently. They have. Shore is a top scholar. It's just that their communications are poor, vague and not informative enough to the public who funded them. And finally, possibly, they could move faster to initiate the FDA process, although this is not completely clear due to the vagueness of their statements.
Didn't De Ridder question Dr. Shore's approach for improving tinnitus? If Lenire got approved in the US, then De Ridder could piggy back off that to get faster approval. It is easier to get devices approved once another one has, that is "close" to an already approved device.
I was reading about 510(k), Greg. It looks like after the quiet phase there will be some back and forth on possible technical questions with a 180 days response limit. Who knows when this will hit the market, let's hope soon for all extreme sufferers. A big hug, my friend.
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