The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is sinking on Monday morning.
At the time of writing, the biopharmaceutical company's shares are down 8.5% to $1.92.
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Why is the Paradigm share price sinking?
The Paradigm share price is sinking on Monday after it revealed that it has received a written response from the US Food & Drug Administration (FDA).
This is in relation to its Investigation New Drug (IND) submission for pentosan polysulfate sodium (PPS) to treat pain in subjects with knee osteoarthritis.
According to the release, the FDA has given feedback on its IND submission and made one request.
The release notes that the FDA's outstanding concern is regarding adrenal gland function. This relates to a preclinical finding in the adrenal gland of rats only. It was not seen in the adrenal gland of dogs. Furthermore, adrenal gland malfunction has not previously been seen by Paradigm or bene pharmaChem in their ongoing pharmacovigilance.
Nevertheless, in the written communication, the FDA has requested modifications to the company's adrenal screening and mitigation plan.
Paradigm plans to amend its clinical trial protocol, including all the FDA's requests, and respond to the FDA within the next week. After which, the company expects a response from the FDA within the next 30 days.
Paradigm's Chief Executive Officer, Paul Rennie, appears optimistic that this could be the final hurdle for the company to overcome before it can push ahead with its trial plans in the United States.
He commented: "Although we understand the agency's obligations for thorough reviews which commenced in March of this year, I am confident that the FDA and Paradigm have now attained a pathway to commence our phase 3 clinical trial in the US."
The Paradigm share price is now down a disappointing 21% in 2021.
