Elite Pharmaceuticals Inc (ELTP)

[vanwes1]

The FDA is not responsible for designing drug study trials. The pharmacutical company is. The FDA evaluates the condition that the treatment is targeting. The pharma can go to the FDA to get guidance interns of trial design, enrollment, and what primary end points need to be met. But most of this information is available to pharma companies unless it is new territory. Like with cancer treatments or rare conditions. The reason the FDA is holding elites hand is because they are probably would like to see the drug get approved but our management can't get their heads out of the ground.