214998Orig1s000 CLINICAL and STATISTICAL REVIEW

214998Orig1s000 CLINICAL and STATISTICAL REVIEW(S)

214998Orig1s000. CLINICAL and STATISTICAL REVIEW(S). Page 2. NDA 214998. Mavacamten (Camzyos). Clinical and Statistical Review. Table 1 ...

214998Orig1s000 CLINICAL PHARMACOLOGY REVIEW(S)

Proposed Indication. Treatment of symptomatic obstructive hypertrophic cardiomyopathy in adults to improve functional capacity, and symptoms.

Mavacamten: a first-in-class myosin inhibitor for obstructive ...

... clinical trials summarized in this review. Based on the ... Clinical and Statistical Reviews Application 214998Orig1s000. https ...

ich harmonised tripartite guideline statistical principles for clinical ...

In this document, the blind review (see Glossary) of data refers to the checking of data during the period of time between trial completion (the last ...

E 9 Statistical Principles for Clinical Trials Step 5

In the statistical section of the clinical study report the statistical methodology should be clearly described including when in the clinical trial process ...

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Study Design Support · Due Diligence Review · Clinical Outcome Assessment (COA) Support · Sensitivity Analyses · Simulation Studies · Meta Analysis ...