Complete Response Letter For Outlook’s Bevacizumab Is Both Straightforward And Elusive
Low On Cash, Rush Is On To Clarify US FDA’s Concerns
Executive Summary
Paralleling the challenges of the wet AMD market it hopes to enter, the CRL for Lytenava cites manufacturing issues, which Outlook Therapeutics feels it can easily address, as well as the need for confirmatory clinical evidence, which has left the firm scrambling for a meeting with FDA.
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