1. From the Phase II 900 patient trial can you please explain how many patients would have had a peak CK-MB greater than or equal to 100ng/ml to put it in proper perspective and show why the failure of the primary endpt of 50ng/ml is significant?
2. From the current 3000 patient trial, how many patients would you expect to have a peak CK-MB greater than or equal to 100ng/ml?
Re MCU/MPH Subsequently Medicure had options in the design of the P3 trial. Certainly they would opt for the 100ng/ml vs the statistically failed 50 if that would be acceptable to the FDA. They could have continued with an endpoint including stroke in that they believe it has a benefit there. Including it would have been stat sig including the 100/ng/ml definition + mortality. However, including stroke benefit adds a variable and may have reduced the statsig number that would make the trial a lock.
They opted to drop the stroke benefit for some reason. I think it is fair to assume they know what they are doing. What was left and what the FDA agreed to was death + MI > 100 ng/ml. The FDA agreed to an SPA based on that primary endpoint. Hogan Mallally at MCU confirmed to me that the MI definition will be using 100ng/ml and will not even measure troponin. To me this looks like a slam dunk.
Maybe they were naive in choosing 50 ng/ml for the pahse II when they initiated it in jan of 2004. That is past history
I question why the hell they need 3000 patients if it's a slam with 1000.
The generic B6 supplement argument is new to me. Certainly cancer and MI scares would not seem to apply here due to the short duration of administration and 250 Mg dosage.
Regarding the lisinopril + MC1 trials. To me the benefit seemed small.
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