As a further example of regulatory flexibility, consider Soliris (Alexion) for Myasthenia Gravis. It failed P3 (p>.05) but was approved anyway based on totality of evidence. In those days, there were relatively few treatments for MG- times have changed but it underscored your point.
As a further example of regulatory flexibility, consider Soliris (Alexion) for Myasthenia Gravis. It failed P3 (p>.05) but was approved anyway based on totality of evidence. In those days, there were relatively few treatments for MG- times have changed but it underscored your point.