I think some readers have missed the point of discussing measures of improvement in patients undergoing treatment with afamelanotide.
By showing a measured improvement in:
1. Treatment efficacy was measured using computer imaging to assess the volume of the area affected by the stroke, and validated clinical assessments of function, neurological impairment, and disability. Analyses of the brain scans (MRI-FLAIR2 ) performed at days 3 and 9 showed a reduction in size of the affected area in five of the six patient; and
2. Analyses of the NIHSS scores1 up to day 42 indicated that all five surviving patients showed an improvement in neurological functions and reduction in overall impairment (p=0.0625). Four out of five surviving patients showed an improvement of 4 points or more on the scale, regarded as significant, and all five patients reported a clinically meaningful reduction of 3 points. Two patients were symptom free at day 42.;
They have shown that treatment efficency can be objectively measured. This means they can now design a future trial which compares afamelanotide treatment with a placebo or alternative treatment. If treatment with afamelantide improves the patients they should be able to show it does, and by how much, using those objective measures. This was the point of discussing measured efficiency in this trial.
Regards
SP
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