I think you need to do a bit more background reading on ixmyelocel-T. For example, the following excerpts are from the Company's announcement of the Phase 2b results:
"The ixCELL-DCM study met its primary endpoint of demonstrating a reduction in the total number of all-cause deaths, cardiovascular hospitalizations, or unplanned outpatient and emergency department visits to treat acute decompensated heart failure during the 12 months following treatment with ixmyelocel-T compared to placebo."
"The ixCELL-DCM trial showed a statistically significant reduction in clinical events driven by both cardiac mortality and cardiac hospitalizations at 12 months compared to placebo. These results are consistent with two previous Phase 2a studies which showed that ischemic DCM patients treated with ixmyelocel-T experienced fewer major adverse cardiovascular events during follow up compared to control patients."
In case you're not aware, when a primary endpoint is met, a trial is considered a success. Secondary endpoints are really just "nice to haves", which are often added with a view to selecting appropriate endpoints for later phase studies. And for what it's worth, the secondary endpoints in Vericel's Phase 2b trial were also indicative of efficacy, just not statistically significant. Furthermore, Vericel has now completed three different studies with this product in ischaemic DCM, all showing efficacy. This is important, as it's unlikely that three different studies would all show similar outcomes by random chance.
MSB Price at posting:
$2.29 Sentiment: None Disclosure: Not Held
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