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Re: SidVicious post# 21529

Tuesday, 12/15/2015 11:28:58 AM

Tuesday, December 15, 2015 11:28:58 AM

Post# of 118383
Ok FDA gives approval that some safety concerrns have been met to their satisfaction to say you can do a trial or trials.

Our question is can they even do a trial?

Do they have the financials to support a trail of whatever design?

Big difference in a Phase 1 and a Phase 3 trial.

Here is another question. During all this FDA waiting time. Do they even have a trial developed at this point that can be started in the coming months. Do they even have any trial sites considered or a trial subject population to target for a trial. How many sites? How many do they want to enroll in the study? When would they even aticipate the start date pending closing the enrolement period to have all the necessary subjects.

Take a look at NVAX who just today annouced the competing of an enrolment period of their study that is to begin shortly. Its a very large study of over 11 thousand enrolled.

GL