“Surely approval will require a bit more than mere trial completion "
Madam - Completion of CHF trial will be driven by the 1st Trial result "test of Superiority" (Trial completion scheduled for Aug 18...FDA agreement to change trial design may significantly reduce the time lines by as much as 12 months).
Of course this does not mean a guaranteed result ( we all know that)
Do you think MSB may discuss with FDA the merit of using the 1st 500 patients (of the 1165 patients) to ALSO check for "recurrent events" ? ( The 2nd Confirmatory Study).
How do you think the TEVA R/Ship is going ?
Please DYOR
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