This is literally the first meeting of many with the FDA and believe it or not they do take note of what the EMA has suggested. It appears it was very much a preliminary meeting, they will be armed with more info next time round. The 65% number comes from the number of single study trials required by the FDA for orphan drugs. As they said if it's safe and shows good results they will be fine, good risk/reward. Also with the green light to Europe and their untapped billion dollar market they can crack that first and then hit the USA if absolutely necessary. The sell off is a complete overreaction of people not understanding the process or not wanting to wait 2 years. Top 20 is tight and the last of the flippers from IPO and CR will get soaked and the V shape recovery will continue. A great analysis by 51 Capital.
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- Ann: Initial FDA and EMA Advice on Presendin Development
Ann: Initial FDA and EMA Advice on Presendin Development, page-44
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