Cgt2009- yes indeed – how does Mace improve without improvement in ejection fraction and left ventricular volume?
According to the P3 CHF agreement (thanks to Techinvestor) Teva can walk if two surrogate efficacy thresholds aren’t met.
And guess what. These are the secondary cardiac functional parameters of ejection fraction and left ventricular volumes as measured by cardiac ultrasound.
So Teva think these secondary cardiac functional outcomes have to improve in order for there to be a good probability of success on the primary.
Trouble is as you note Cgt2009 there was zip efficacy signal from the P2 study on these surrogate outcomes.
I suspect what is going to happen here is that this trial will be completed as a P2b proof of concept with around 200 subjects. Which arguably is what it should have been in the first place.
http://www.sec.gov/Archives/edgar/data/1345099/000119312515361222/d943277dex1031.htm
MS.. Cured by stem cells ?, page-35
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