the other TGA approved products don’t contain a new chemical entity such as SPL7013 which is regulated as drug for Vivagel. That’s perhaps why trying to get rescheduled?
what a crazy situation when regulatory shortcuts go bad over and over. Some people needed at SPL to learn how to work with regulatory agency and not think they know better. SPL getting bad reputation with TGA FDA MHRA and perhaps others we don’t even know about because SPL not tell us. Looks like problem in INdia too where may have done medical device listing with no regulorty review or approval and now distribution partners won’t touch it. What else are we not being told??
The Age, page-10
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