regarding trial costs: "The trial sponsor usually pays for the cost of the intervention being studied (for example, any drugs not currently approved for your condition). The sponsor may also pay for the cost associated with any special testing or extra doctor visits that are required. "
If the drug cost is extraordinary the sponsor can petition the FDA to charge the patient or a third party payer.
- Amarin supply ALL CTM (clinical trial material), distributed by CRO. It isn't via health plans or pharmacy ... it is a double blinded trial - "an immediate increase of about 3,500 scripts" ... could be app. 3,200 ... placebo AND V arms patients in the US ... V isn't available for non-US participants