Absolutely! I'm very happy with this ann. It means the halfway point for FDA review is that much quicker, where the FDA will look for 'overwhelming efficacy' . MSB is a pioneer in the field and the FDA is modifying its criteria appropriately. The risk which applies to the pharmaceutical model, is shrinking into the model being developed by the FDA. Exciting times.
It's fascinating watching hottuna persistently try to spin a negative into this obviously very positive ann.
Ann: Phase 3 Heart Failure Trial Size Substantially Reduced, page-41
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