Since you follow the space and are aware of the alxn results you also know that the peak ck-mb of 100ng/ml is the most appropriate endpoint and medicure's data shows that it reduces the risk of MI and death when that marker is used.
No 100ng/ml is not the most appropriate endpoint. Can you please explain how you come to this conclusion?
Since you follow the space and are aware of the alxn results you also know that the peak ck-mb of 100ng/ml is the most appropriate endpoint and medicure's data shows that it reduces the risk of MI and death when that marker is used.
The phase 2 only had 900 patients and they thought by lowering the endpoint to 50ng/ml they would see more events but it created noise.
but then again I am sure you knew that
1. Was there not more mortality/stroke in the two treatment groups compared to placebo? Cause for concern in a trial to reduce mortality? Thoughts?
2. Any thoughts on the following?
Most studies have found a good correlation between the degree of CK-MB elevation and mortality risk, with higher risk for patients with CK-MB >5 times above the upper normal limitKeep in mind 100ng/ml=20 times upper normal limit
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