I was wrong about the phase 2. Rex alone wasn't used. It was saline control, HC control, and two different doses of Rex with HC. That phase 2 showed negligible benefit from HC alone. So phase 3 just used saline control but also added an arm with Rex alone. Which did show a benefit, but not as strong as the combined treatment. The combined treatment is what is being proposed for approval, it shows clear efficacy over saline placebo, and there is evidence as to why the HA would make the Rex more effective. And now we will have a second phase 3 to show benefit of the combined treatment over placebo.
So if the Doc is so concerned that HA alone could really be just as good, he is free to go do more studies, while we are busy helping people with our combined treatment.
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Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-173
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