re: Ann: Media release - FDA allows world fir... Concerning the EPP phase III or MAA in the USA I still think that there is a good chance of having the MAA allowed based on EU MAA dosier and together with starting a phase III confirmatory trial in the USA.
Somehow I cannot imagine that the USA would stay behind of the EU for a drug that:
*can really help people that suffer a lot
*was invented in the US
*has an very impressive safety profile
*has quite some positive trial outcome over the past 2 decades
It just dont fit the picture for the US to delay this.
I must agree that many regulator members are notoriousely conservative. And in the end it is true that patients can also just stay out of the sun. (this is not my opinion but was said to me by a dr from EMA about 2 years ago)
Ann: Media release - FDA allows world first vitil, page-3
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