Thanks to all those contributing to this excellent thread.
There is a lot for MSB to answer, but that's not a surprise. As I've said out there in the snowstorm, the questions asked are predictable and naturally arise from facts known to FDA when they granted priority review (eg. no clearly establlished moc, single arm trial, significance of old trials). FDA was never going to rubber stamp this. Just doing its job. I'm confident that we will get a favourable vote from the panel (at least by majoirity). I say this because I believe FDA's questions have been comprehensively and/or adequately answered and my guess is that the panel will think so too.
We should know the outcome of the vote by Friday's ASX open. If the answer is yes, I think FDA approval before 30 September is a slam dunk.There will be an ASX announcement before open on Friday and there will be a mad rush of shorts covering, others buying back in and still more increasing current positions.
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