So no repeat of the canine trials of 1993 for Biogen......clearly the data must've been very 'paw' for the FDA to impose that on PBT. Unfortunately the FDA persists.......ODAC committee formed to advise the FDA voted 7-0 AGAINST ....but still they approve ? MSB achieved 9-1 vote IN FAVOUR of ryoncil......FDA says more RCT required......moral to the story.....NEVER punt (invest) too much money on a the FDA approval outcome....particularly if you are an Aussie biotech. Yanks are our best friends when it comes to geopolitics but forget the field of medicine or medical science......look after number one BIG PHARMA is the mantra from my experience !!!
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