RE:RE:RE:RE:Australia and EU Hi Frznth,
I have had some experience, mostly because they have spent a lot of time reviewing results of submissions, which are publicly available but you do get an understanding of how they make their decisions.
So, my thoughts only, and I have no affiliation with any of these regulatory bodies just to be clear.
So to your points/questions:
" It wasn't clear why subjects were improving. "
I had a long back-and-forth with Prokiev and a few others about a year ago on this and I will not repeat it. Strictly speaking, there was no true evidence of efficacy, based on the sham treatment.
Notwithstanding that you can show an improvement, using an evidence-based approach, can see that that was simply a placebo effect, and effects will be judged as nominal,
.
I am not saying there was not an effect, I am just saying how evidence is interpreted according to current guidelines.
There is a lot of emotional investment here with people, and logic did not seem to make sense then, and maynot now , but that is just the way it is.
"But if the new study shows that patients can't make the gains they are making from physical therapy alone, how can the FDA not approve? "
If they can show, using pre-specified endpoints, using accepted statistical methodology, that this is the case, then yes you can make the case that there is efficacy. Whether or not they will approve it or not, would also depend on the safety. In my view you have a much higher likelihood at that point.
Still, its a long road ahead, and looking at the finances on the recent reports, you can judge how likely that is.
"Also - Won't the real life results of patients getting better in Canada help support the submission?"
In my view, almost certainly not.
I have seen many posers here over the last year talk about videos and testimonials, and these are not considered strong evidence, and in many cases not even considered.
Again, my view only-all of the above, and dont invest or not based on my views.
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