MSB to dispute FDA finding in Type A meeting, page-182

Are you familiar with the US administrative review processes as they apply to decisions made within the FDA?

Maybe the FDA “bureaucracy” referred to being required to be navigated here involves a careful game of chess where the rules of the game involve not just administrative processes within the FDA rule book but also the broader legal system administrative review processes. I’m not in the slightest suggesting that MSB need to get “legal” by taking suit against the FDA but I’d be pretty confident that the MSB legal team are well aware of arguments of reasonable exercise of administrative function required to be employed in FDA decisions. It may all just be a case of careful layering of the processes. I daresay that more will become evident on this aspect in due course. All my opinion of course but I think there is a far greater and longer “game” being played here. Buying opportunities will be coming up for longer term players (short term players will have different objectives in mind).