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Cantor Comments on Ocular Therapeutix Inc (OCUL) Following FDA Form 483 Observations

The FDA has handed Ocular Therapeutix Inc (NASDAQ:OCUL) a Form 483 detailing observations made during the second review of the manufacturing site by a new investigator. The Form 483 contained inspectional observations focused on procedures for manufacturing processes and analytical testing, related to manufacture of drug product for commercial production.

Cantor analyst Elemer Piros commented, “We believe the items discussed on the call remain manageable and do not delay the current regulatory timeline. Several issues relating to particulate matter...