At the AGM the CEO clearly explained that the TGA application was withdrawn because the TGA indicated they would only accept an RCT and not a single arm study. Pretty simple. Maybe the previous CEO wanted to roll the dice on rejection, but the current one didn;t.
So the application was withdrawn.
Remember Australian doctors and patients can still, and have, access/ed the treatment on SAS.
You can be critical of the previous Board and management for not conducting even a small RCT. That was a mistake. But there's no conspiracy.
The company has at least 2 RCTs in the planning, and either will likely satisfy TGA. But they will more importantly help get public reimbursement in Europe.
Please be calm.
OSL Price at posting:
4.8¢ Sentiment: Buy Disclosure: Held
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