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Pharmacyclics’ Xcytrin Gets FDA “Not Approvable” For NSCLC Patients With Brain Metastases

This article was originally published in The Pink Sheet Daily

Executive Summary

CEO Richard Miller calls for FDA to release the “biotech bottleneck” caused by its approvals process.

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Pharmacyclics Taps Little-Used Regulatory Pathway For Xcytrin NDA

Firm’s decision to “file over protest” asks FDA to review NDA that received “refuse to file” letter in February.

Pharmacyclics Gets “Refuse To File” Letter On Xcytrin

Company had hoped for priority review when it submitted its NDA for treatment of brain metastases from non-small cell lung cancer in December.

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