Interesting to note they had meeting with the FDA prior to clinical testing ??
"Research partner Naval Medical Research Centre (NMRC) met with the FDA on behalf of Immuron to discuss the chemistry, manufacturing, and controls of the new drug, as well as the proposed testing specifications of the product. On top of this, the two parties outlined planned clinical studies to test the drug's safety and effectiveness.Immuron CEO Dr Jerry Kanellos said the FDA discussions for the new product are an important milestone when developing any new drug for therapeutic evaluation."The information obtained from this review will assist in the development of the Investigational New Drug application and provides a clear roadmap forward for conducting the two planned clinical studies next year," Dr Jerry said."The company is also pleased to inform shareholders that the manufacturing program is proceeding as planned," he added."
Cell Therapy News/Articles, page-4790
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