I'm finding this waiting longer than expected experience (again) tough to take, I'll admit.
When I don't know what is going on behind the scenes, I have to trust my gut.
My gut tells me that if the FDA or TGA had found a solid reason to reject our application they would have done it already. One good reason to knock us back, and I reckon they are not going to spend more valuable time and resources on it. If they are asking for more information, it will more likely validate or add weight to our data, and it will cover their behinds.
No-one has disputed the effectiveness of the drug.
No-one has claimed to have suffered serious adverse events.
Bring on a decision, and soon! A nod from either organization and we can move on.
I'm finding this waiting longer than expected experience (again)...
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