Kak..good on you for pushing through the garbage and seeing exactly what the change in P3 primary end point means. As Maxim noted, once commercialized, the Market is Global .. ...and as alluded by another poster is that once commercialized Revasor can be used by all Class 2/ 3 patients regardless of level of level of disease. Also given the shorted 600 patient trial (as noted by Maxim) , how will this change the previously advised interim analysis on the ongoing P3 trial when 50% of the HF-MACE have occurred, which will include a test for superiority – this I believe wan anticipated in ~1ST Qrt CL 17 (March) . No doubt we will hear more in due course.
Aa ..spot on. TEVA are definitely driving this trial and as recently noted by SI , they are leading the discussions with the Clinicians and the FDA.
GLTAH.
Trial changes, page-2
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