For that to happen the Phase II DIPG combo trial needs to have truly impressive data in the interim analysis - impressive enough to move to the preparation of the NDA to FDA when the trial is not complete.
Time is of the essence here - the voucher will only be granted if paxalisib’s first FDA approval is in a paediatric indication.
There‘d be more time for the DIPG trial if GBM AGILE was negative for paxalisib.
But I doubt anyone here would want this. Positive GBM AGILE data should impact Kazia‘s share price in a way that a tradable FDA review voucher simply cannot.
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For that to happen the Phase II DIPG combo trial needs to have...
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