I think it would be futile(haha get it) running on the assumption they can join up the markets into one trial.
IMO better planning for the worst and jumping through any hoop the FDA tells you to jump through...I say this because if you look at all of the failures mentioned here in this space, this may mean the FDA doubles down with extra caution and may not be as likely to accept just a European result.
It may compliment the US stuff, sure, but ANP should plan for the long road and if it then becomes shorter because theyve done things the right way, bonus.
Does anyone have an idea on the cost of nine months of toxicology and does anyone have good knowlesge of FDA approving stuff just based on international trials? Re-reading the AGM slide it seems a lot of hope (based on EU) and really doesnt outline a plan b.
GLAH
EQUITY RESEARCH REPORT - WILSON dated 18 Jan 2022, page-126
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