Iterum Therapeutics 8-K Shows Co., On Apr. 8, 2021, Received FDA Notice 'it needs more time to review materials that have been provided by the Company in support of the Company's new drug application for sulopenem etzadroxil/probenecid...'
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Iterum Therapeutics received a notice from the FDA indicating a need for more time to review the materials provided for the new drug application of sulopenem etzadroxil/probenecid.
April 09, 2021 | 11:37 am
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Iterum Therapeutics has been informed by the FDA that additional time is needed to review its new drug application for sulopenem etzadroxil/probenecid, potentially delaying approval.
The FDA's request for more time to review the drug application suggests a delay in the approval process, which could negatively impact investor sentiment and the stock price of Iterum Therapeutics in the short term.
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