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"While we acknowledge your response that an abrupt shortening of the enrollment period led to challenges and mistakes, your response is inadequate because, regardless of the length of the enrollment period, you are still responsible for ensuring that subjects meet protocol-specified eligibility criteria before you enroll them into the study," said FDA

The new approval is based on data from the Phase III FLAURA 2 study, where Tagrisso plus chemotherapy prolonged progression-free survival by around nine months compared to Tagrisso alone