Looks like Nov 11 is a big day for us blasters, "well may we say, god save the queen, cause nothing will save the shorters":
- Class IV End-Stage Heart Failure. This is a trial in very ill patients who are being supported by Left Ventricular Assist Devices (LVAD). The idea is to help restore the heart muscle by injecting cells (MPC-150) at the time the LVAD is implanted. The trial is a Phase 2b, 159 patient study, (enrollment is complete), which has received the Regenerative Medicine Advanced Therapy (RMAT) designation. The primary endpoint is temporary weans from LVAD at six months. We expect data by Q4 of this year and possibly at the American Heart Association meeting in November. Good data from this single study should support approval. The LVAD opportunity itself is small however we note that the same product and dose are being used in the larger Class II-III HF trial. As such, we might view the LVAD trial as a surrogate for the larger HF opportunity.
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- H.C. Wainwright / MESO - Initiating With Buy
H.C. Wainwright / MESO - Initiating With Buy, page-8
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