- Paradigm Biopharmaceuticals (PAR) submits its response to the US Food and Drug Administration (FDA) in relation to its knee osteoarthritis study
- In preparing the response, Paradigm consulted with multiple experts to review the document and ensure it contains sufficient information
- Paradigm believes that the input from these experts will increase its likelihood that it will meet the requirements of the FDA
- The FDA will now review this response over the next 30 days
- Just before the market opens this morning, Paradigm is trading at $1.94
Paradigm Biopharmaceuticals (PAR) has submitted its response to the US Food and Drug Administration (FDA) in relation to its knee osteoarthritis study.
Last month, the company received written feedback from the FDA, which included questions in relation to recently completed non-clinical studies evaluating pentosan polysulfate sodium (PPS) in knee osteoarthritis.
In preparing the response, Paradigm consulted with multiple experts to review the document and ensure it contains sufficient information.
Paradigm believes that the input from these experts will increase its likelihood that it will meet the requirements of the FDA.
The FDA will now review this response over the next 30 days.
“We have responded to the FDA’s questions following diligent reviews with our Internal team and consultants,” CMO Dr Donna Skerrett said.
“We believe these responses are sufficient to assure the agency the program is supported by non-clinical and clinical data and that the objectives, rationale, and study design will aim to demonstrate the safety and effectiveness of PPS for patients with painful osteoarthritis of the knee.
“There is a clear unmet need for patients who have not had adequate responses
to initial therapy for knee OA and have ongoing pain. Prior experience with PPS in clinical and non-clinical settings has demonstrated the potential to address this unmet need.”
Just before the market opens this morning, Paradigm is trading at $1.94.