Company News Summary | 26 Apr 2021

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Paradigm Biopharmaceuticals Provides Investigational New Drug (IND) Application Update

09:14:00 | Associate analysts


Paradigm Biopharmaceuticals reported an update on its IND application to the US Food and Drug Administration (FDA) for the proposed pivotal clinical trial treating subjects with pain associated with Knee Osteoarthritis (OA). On 23 April 2021, the Company received a verbal indication from the FDA that the FDA would be putting further questions to Company outside the 30-day IND review period. The FDA was unable to provide all questions within the initial IND review period and has advised it will submit them to Company within the next 30 days. Many of the questions are related to newly submitted non-clinical data (as part of the IND application). The Company is ready to review and answer questions when they are received.

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