How does the large enrollment in the registry CAS arm affect interpretation of results?
The panel noted that patients were placed in the registry for various reasons, some identified, some not. The data collection forms describing clinical characteristics have not yet been culled to ascertain differences and similarities. The outcome of propensity score analysis remains in abeyance in part because of the lack of covariates examined. Without answers to those issues, making comparisons is premature and perhaps hazardous. The large exit of patients from the original trials to the registry qualifies the results of the SAPPHIRE trial. Question 3: How does premature termination of the pivotal randomized study affect conclusions derived from the study? The panel referenced its earlier discussion. The Agency should continue to discuss the matter with the sponsor. The endpoint was addressed and found to be adequately powered to reject the null hypothesis, and the premature termination was not the result of inappropriate or biased looks at the data. Question 4: Please discuss how d
