Complete Response Letter For Outlook’s Bevacizumab Is Both Straightforward And Elusive
Low On Cash, Rush Is On To Clarify US FDA’s Concerns
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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Pinning its hopes on its proposed bevacizumab product for ophthalmic indications, Outlook Therapeutics has been told to give more information to the US FDA ahead of an approval. However, one analyst remained upbeat for the company’s prospects.
Boehringer expects Jardiance’s new chronic kidney disease indication to keep its sales growing by double-digit percentages over the coming years, aided by the drug’s ability to reduce hospitalizations.
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