Novartis - Heart Failure - Primary Endpoints, page-3

Thanks @Moreforme ... who would have thought the FDA approving a drug that didn't meet its PE; the FDA even encouraged the application from Novartis .... makes for interesting conversations with MSB and the FDA about Rexlemestrocel-L (REVASCOR® especially if Novartis partner with MSB for CHF as well as ARDS


The agency primarily based its review on results from Novartis’ Phase III PARAGON-HF study, which, unlike most other successful pivotal trials, didn’t actually hit its primary endpoint of reducing the rate of total heart failures and death. Despite the flop, the FDA urged Novartis to pursue its application anyway, arguing the study’s design may have produced misleading results — the primary endpoint’s p-value was 0.06, by the way — and highlighting results from pre-specified follow-up analyses that pointed to significant benefits.