What is your probability that AZN stays in the program?
High. Maybe 85%. If for no other reason than to play keep away (from PFE etc).
Assuming that there is no immediate FDA submission: a) What is your probability that the drug is repositioned as a diabetes treatment? b) What is your probability that the drug will ultimately be approved?
A lot of uncertainties still. E.g. how long will the patents last? Long enough to make another heart trial worthwhile? (I don't fully understand the drug IP rules that allow extension).
But at this point I'd say 70% chance it will be approved for diabetes within 4 years. And it will be either first in class or tied. Biggest uncertainty is liver failure question - but that is probably not a real issue since, for instance, Rosuvastatin in their approval trials had 2 cases of jaundice in 12,000 patient years (vs 1 case of "reversable liver failure" per 6000 patient years for AGI-1067). But more research still required.
But note that being approved for diabetes does not preclude being approved for Cardiovasc disease. I would still expect this to happen barring a patent run out issue. 20% in MI/Death is pretty good and it is a pretty firm number despite the barely stat sig p value.
As a courtesy, can you break out the reported HR for each component—and each combination of components that was reported or can be calculated—of the primary efficacy endpoint?
Overall HR was 1.00. HR in Cardio death+MI+Stroke was about .81. HR is Unstable Angina was close enough to 1 to make no difference. And, from memory, HR in revasc was about 1.2. Trade one MI/death for one revasc seems like a good trade even to me -g-.
What, if anything, did you learn from your discussion with MH
Nothing. Just provides feedback on what the press is thinking.
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