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- Paradigm Biopharmaceuticals (PAR) has told shareholders that there will be a delay in its proposed phase three osteoarthritis clinical program
- The late-stage drug development company had expected to report the top-line results from the trial of its Zilosul drug before the end of 2022
- However, due to a COVID-19 delay in the written response from the Food and Drug Administration (FDA) Type C meeting, the results are now scheduled for the first quarter of 2023
- Depending on the feedback from the FDA, Paradigm may also increase the number of participants in the proposed trial
- Shares have been trading 3.45 per cent higher at $2.70 at 10:35 am AEDT
Paradigm Biopharmaceuticals (PAR) has told shareholders that there will be a delay in its proposed phase three osteoarthritis clinical program.
The late-stage drug development company had expected to report the top-line results from the trial of its Zilosul drug before the end of 2022.
However, due to a COVID-19 delay in the written response from the U.S. Food and Drug Administration (FDA) Type C meeting, the results are now scheduled for the first quarter of 2023.
Paradigm submitted the relevant documents to the FDA on July 20, 2020, and expects to receive a response shortly.
Depending on the feedback from the FDA, Paradigm may increase the number of participants in the proposed trial.
Paradigm will share the details of the study timeline and participant numbers, following the anticipated receipt of feedback, at its R&D day on December 21, 2020.
Shares have been trading 3.45 per cent higher at $2.70 at 10:35 am AEDT.
