Not a holder but have been investing over last decade on aussie biotech stocks so this caught my interest.
I have gone thru this multiple times and it is likely to end in tears. It is obvious FDA has issues with this drug and will not approve it. More than likely they will require another expensive and lengthy clinical trial.
Because it is approved elsewhere in the world has zero bearing on FDA approval. However the opposite is true - if FDA has approved it then much easier for EU AU etc approval.
If what I think occurs on Friday then expect a minimum 12 more than likely 18 month+ delay.
Finally - that non-binding nature of the review panel is a misnomer - if the panel of experts appointed by the FDA does not approve then there is not coming back - FDA will not override their decision.
Anyway good luck for Friday. Remember the no1 lesson in investing - do not invest what you can’t afford to lose.
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