GI bleeding would be an approvable indication - this is a serious adverse outcome of high frequency in the LVAD patients and unless there was some serious side effect the FDA will approve on this indication alone.
The unknown is if the FDA thinks the last trial (in combination with the P2 trial results) is enough. For a large and healthier patient population it would be a certain no, but in a small really sick population like the LVAD patients it might be enough. It is certainly worth MSB talking seriously to the FDA to find out what they think.
Ann: P3 Trial of MSB's Cell Therapy in CHF Completes Recruitment, page-38
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