If FDA agrees to accelerated approval, MSB will be at the stage circled below.
There is absolutely no way that they allow this product to go to market, while confirmatory data is being collected, based on the previous trial that failed to meet endpoints and produced data that makes no mechanistic sense based on our understanding of heart failure.
They will require a further trial, which may be ended early based on surrogate endpoints, that allow the product to be released to market with confirmatory trials ongoing.
Even if the FDA give accelerated approval, they will design, recruit, and partially run a trial prior to release to market.
Pick Today's Price Range Low-High... Just for Fun, page-53
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