" the FDA have essentially given us a ticket to approval if can replicate results"
That may not be entirely true. There are many different methods of evaluating pain in patients and in the last trial it wasn't as robust as it could have been. While the end points may have been accepted, the methodology may not have been discussed or approved by the FDA.
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- Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain
Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-195
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