>The overall pathophysiology [of CABG/HR] is better understood today and the rationale "clearer".... I'm sure both Ovation and GTC have consulted both the FDA and have lined up cardiac surgeons…This is perhaps the part of the reason for delaying the announcement of the partnership.<
One major difference between then and now is that this time GTC/Ovation will obatin an SPA before proceeding to phase-3 in the CABG/HR indication.
SPA’s did not exist when the orignal phase-3 trials in CABG/HR commenced in the late 1990s; if they had, things might have turned out differently.
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