Disappointing setback yes but I see the positive. No hint of any major structural issues ie the technology and efficacy seems to be sound = not rejected and does not require more Phase 3 trials. Again are there any medical products approved in NZ but not in AUS? It appears that the TGA issue is not querying Colostat per se but the reliability of the manufacturing process overseas - perhaps this would be less of an issue if it was produced locally by a manufacturer already trusted by TGA ie the question mark is really against Biotem rather RHY.
Ann: Update to TGA Submission, page-45
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