The share price of Paradigm Biopharmaceuticals Ltd (ASX: PAR) is down today on an update of its new drug application. What does this mean for the Paradigm share price?
Paradigm has repurposed an anti-inflammatory drug called pentosan polysulphate sodium (PPS) to treat multiple new indications, including Osteoarthritis.
PAR share price
Paradigm to answer more questions
The company has provided an update on its new drug application to the US Food and Drug Administration (FDA). This is in relation to the proposed clinical trial, treating subjects associated with Knee Osteoarthritis (OA).
After submitting its application on 26 March 2021, Paradigm has received a few questions from the FDA.
These questions were answered within 48 hours of receipt.
However, on 23 April 2021, FDA verbally advised that it would be asking further questions and will submit these questions within the next 30 days.
The company’s understanding is these questions are related to newly submitted non-clinical data.
What now for Paradigm?
Paradigm has advised its prepared to review and answer questions once received and will keep investors up to date.
The future profitability of biotech companies is often determined by the quality of research and development, which needs to be approved by the FDA.
Unless you have expertise in this field and it’s within your circle of competence, I would try to avoid investing in this industry.
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