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- Paradigm Biopharmaceuticals (PAR) has received written feedback regarding its investigational new drug submission for a study evaluating knee osteoarthritis
- The U.S. Food and Drug Administration’s (FDA) feedback contained questions in relation to recently completed non-clinical studies evaluating pentosan polysulfate sodium (PPS) in knee osteoarthritis
- Paradigm says its responses are consistent with the FDA’s suggestions, and it remains on track to submit its complete response to the agency within 30 days
- Meanwhile, Paradigm is continuing phase three study preparation at sites across the U.S. and Australia
- Paradigm Biopharmaceuticals last traded at $2.32
Paradigm Biopharmaceuticals (PAR) has received written feedback regarding its investigational new drug submission for a study evaluating knee osteoarthritis.
The U.S. Food and Drug Administration’s (FDA) feedback contained positions and questions in relation to recently completed non-clinical studies evaluating pentosan polysulfate sodium (PPS) in knee osteoarthritis, treating pain associated with musculoskeletal disorders driven by injury, inflammation, aging, degenerative disease or infection.
The feedback also suggested mitigation strategies to address its position and questions, which further detailed clinical monitoring.
Paradigm, a late-stage drug development company, says its responses are consistent with the FDA’s suggestions and it remains on track to submit its complete response to the agency within 30 days.
A review and response from the FDA will then be due within 30 days of the receipt.
Meanwhile, Paradigm is continuing phase three study preparation at sites across the U.S. and Australia. Further sites may later be added in order to complete the pivotal study within the planned commercialisation timelines.
Paradigm Biopharmaceuticals last traded at $2.32 on May 24.
