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Paradigm Biopharmaceuticals Reports Investigational New Drug (IND) Application Questions Received from US Food And Drug Administration (FDA)

25 May 2021  |  09:02:00  |  Associate analysts  |  Increase  |  Decrease  |  

Original announcement: IND QUESTIONS RECEIVED FROM US FDA

Paradigm Biopharmaceuticals reported that it has received written feedback regarding the IND submission for its pivotal study evaluating PPS in knee OA. The agency's feedback contained its positions and questions principally in relation to recently completed nonclinical studies. The agency also provided its suggested mitigation strategies to address its positions and questions, which included further detailed clinical monitoring. Its responses to the FDA questions will include mitigation strategies consistent with the FDA's suggestions as well as clarification of existing study data.

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