Outlook Therapeutic Says 'The FDA informed Outlook Therapeutics that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 for the treatment of wet AMD'
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Outlook Therapeutics has been informed by the FDA that an additional adequate and well-controlled clinical trial will be required for the approval of ONS-5010 for the treatment of wet AMD.
November 02, 2023 | 12:08 pm
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Outlook Therapeutics' ONS-5010 approval process for the treatment of wet AMD is delayed as the FDA requires an additional clinical trial.
The FDA's requirement for an additional clinical trial means a delay in the approval process for ONS-5010. This could potentially delay the product's launch and impact the company's revenues and stock price negatively in the short term.
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IMPORTANCE 80
RELEVANCE 100