Biotech Values

[investorgold2002]

"“substantially underway”"
When asked FDA means by that...
I believe in one of the cc's they said they should be in position to do this by 2nd quarter 2012. Keep in mind in their april cc they said they are almost done with design of CV outcomes trial and they are talking with number of global CV experts to put final touches to this outcome trial design. they also said, 5k patients would be enough. And they also mentioned it wouldn't be hard to find/enroll 5k patients(the type of patients for this trial) in accelerated period.
I think 2nd quarter 2012 is still aggressive but this company of 22 employees has a trail of over-achieving and under-promising.