@mirri11 - this is my key take-out too. The results gives us some insight into why non-responders were excluded from the initial FDA application. For example, reverse engineering some of the figures, it appears that LVESV improved on average ~10% for non-responders (vs 18.2% for the primary population). This is of course slightly above the efficacy endpoint, but unlikely to be statistically significant (particularly given the low volumes).
Otherwise, the result illustrates what we already knew. That is, (1) WISE is an effective treatment for heart failure in higher-risk CRT patient populations, (2) it meets key clinical and patient endpoints and (3) will likely receive FDA approval. Hence, why I find the price changes over the past couple of days a little bizarre. Not sure what the market was expecting.
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- Ann: Positive Results from the SOLVE-CRT Randomised Sub-Study
Ann: Positive Results from the SOLVE-CRT Randomised Sub-Study, page-9
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