Joelsmith people banging on about medical device vs medicine need to understand 2 things.
SPL7013 will imo be an active for future indications and the likelihood needing to be delivered as a device are high imo. Having it approved to be assessed as a device atm through TGA is a big win for future applications.
If we went down the pathway of clinical trialing it as a medicine we likely still wouldn’t have it at all. And not likely for a few years. Got to be careful what you wish for. This way at least we have it. It’s making money. Nothing stopping us running clinical trials to have its therapeutic status upgraded to a medicine post TGA approval and I believe they may do that imo. It’s been a rough ride but I believe the best strategy by management.
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