Teva were originally required to recruit 1700 patients, after some time and negotiation with the FDA they reduced it to around 1150 (excuse the approximations- I'm on vacation). Then after more negotiation with the FDA, the sample was reduced to 600. And the end points changed to include multiple heart failure events per patient.
This makes it a much more cost efficient and time efficient trial. Hence the delays in starting the trial- and recruiting efforts have really only recently started, it will expand to Europe this quarter.
New timetable to be released in the coming weeks.
Teva were originally required to recruit 1700 patients, after...
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