Anti - good question but cannot give you a factual and scientific response - and no one really can other than respected authorities like FDA , Texas Heart Institute , National Health Institute and like organizations.
What we do know is that there is a critical and large unmet need (particularly Class 2 & 3 CHF patients). And based on the recent trial revision and change in endpoint , it appears that the FDA are giving TEVA all the assistance and opportunity possible (based on strong science and robust endpoints), to deliver a application that can make a difference to millions of people worldwide. With time to commercialization taking 10 years + (likely 12) + patents , any CHF successful application will be the gold standard for decade at least .
Not going to discuss the SP ( too many tactfully smart people out there who would have a more unmistakable explanation). With Nasdaq behind us (cash raised + 5/6 qrts), in my view we are now heading into a number of SP leading events including Temcell Launch Japan; RA update ; CHF interim (Teva/Msb co-update) and what we have all been waiting for.
Yeah I know - the boy that cried wolf ...BUT The Wolf, however, did truly come at last.
GLTAH
What future CHF therapy, page-8
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