Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION, page-5

ASX RELEASE 27th September 2021PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION
Paradigm Biopharmaceuticals Ltd (ASX: PAR) (Paradigm or the Company), wishes to inform the market it has received a written response from the US FDA in relation to its Investigation New Drug (IND) submission for pentosan polysulfate sodium (PPS) to treat pain in subjects with knee Osteoarthritis.
In response to the FDA's one request, Paradigm will make an amendment to Its protocol.Response received from the US FDA The one outstanding question regarding adrenal gland function related to a preclinical finding in the adrenal gland of rats only and was not seen in the adrenal gland of dogs. Adrenal gland malfunction has not previously been seen by Paradigm or bene pharmaChem in their ongoing pharmacovigilance. This one preclinical finding has been the focus of the ongoing US FDA review. Paradigm, working with external endocrinologists, presented changes to the clinical trial protocol, which included a comprehensive adrenal screening protocol and clinical monitoring as part of its mitigation plan. In the written communication, the FDA requested modifications to Paradigm’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. Paradigm assumes the FDA may again take 30 days to respond.
Mr Paul Rennie, Paradigm Chief Executive Officer:“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”.