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Re: DaubersUP post# 258204

Thursday, 03/14/2019 1:39:40 PM

Thursday, March 14, 2019 1:39:40 PM

Post# of 403599
The phase 3 is going to be designed with input from both the FDA and EMA. This means if the trial is executed per protocol and satisfactorily meets endpoints (agreed upon by both the FDA and EMA), approval of the drug should be granted by both the FDA (to be sold in the US) and EMA (to be sold in Europe).

Additionally, since we will have clinical sites in both US/EU, it should save a little money on cost since most EU sites will be less expensive for us. That should speed recruitment as well.

I think this is big. I'm guessing some of this is being directed by a potential partner.
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