“The first steps are to gain comfort that the intervention with afamelanotide poses no harm to patients, while obtaining objective measures of impact of treatment on the course of the patients’ disease. With CUV801 we have achieved both these outcomes and can now pursue further studies and regulatory interactions with a degree of confidence that the drug performs as expected.”
Yes, I agree, it wasn't presented, but I believe that it was inferred by the MRI-FLAIR indications they saw, It inferred that they were better than what is normally seen. Note 2 seems to suggest that.
Highlights by me.
GLA
Ann: Positive Final Results in Stroke Study CUV801, page-27
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