My understanding is that TGA follow EMA and FDA if any applicant is going through either. If anyone knows of exceptions that would be illuminating.
Furthermore, the criteria that @Babbanap mentioned regarding TGA being progressed, viz
For treating a serious conditionFavourable comparison against existing therapeutic goodsMajor therapeutic advanceEvidence of a plan to submit comprehensive clinical data.
are promising for us, but given the schedule, it doesn't look like it saves any time compared to FDA, since the minimum time is around 150 working days + any questions that FDA come up with that need to be answered, and my guess is that TGA would wait on those answers being accepted. So whereas in the past i thought TGA offered a faster path, with the delays we have, i think what it offers is an alternate path, which won't be cost-free, but is worth pursuing providing we have money.
Referencing @TanamiRod i heartily agree with your description. I think we have reached the point that the Board understand that they have to be factual above all else. The question is, who is going to speak to us that we can believe? ( i don't mean Simon, he is just passing on what he is given to tell us, i mean a member of the Board and not you know who).
Finally, in retrospect, i don't see that FDA have any grounds for rejecting the 2mg dosage. About all i think they can justify are questions on safety. That would be a significant nuisance, but one which I think @Mozzarc has already provided answers, so PAR can just copy those!
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