I agree with CUV101 on this - the study did not and could not demonstrate efficacy - for that you need some form of comparison data of the normal recovery rate from stroke. They could have done the trial in people with broken legs and low and behold, 6 weeks later there was a nice improvement in bone healing as shown by X-ray, mobility, pain and quality of life. Can you say the Scenesse did it? Of course not as there is a natural rate of healing and recovery that occurs in a fracture as it does with a stroke. What you need to know is if the recovery is quicker/better with a drug intervention. I'm not being negative on the trial at all only that you can't read anything about efficacy into it (and CUV shouldn't even have used that word in the release) and it wasn't even designed to address that even with a n=6 - that would need larger trials designed to address this and with an appropriate comparison group.
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- Ann: Positive Final Results in Stroke Study CUV801
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clinuvel pharmaceuticals limited
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Ann: Positive Final Results in Stroke Study CUV801, page-22
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