What the FDA thinks and does is what will determine approval in the USA, and that is a risk that worries me because it is always possible to get an unfavorable decision “for whatever reason, just or not.” Especially in today’s climate of fake news and political and monetary influences. Hopefully the trial data will be strong enough to win the day.
The fact that there are 4 approval agencies, 3 others than the FDA, evaluating the same trial results means there are “multiple shots on goal,” and some self policing among the approval agencies since their decision will be seen and contrasted along with the others. Also since there would be a national competitive factor, the FDA and the other agencies have to think about disapproval of a meritorious treatment that may be available elsewhere and be shown of benefit elsewhere.
So I think LP and team were very strategic in doing a multinational trial.
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