Oppenheimer takeNo new study needed to prove explanation if clearly documented that some patients are carved out because of protocol non compliance. Examples as cited by Oppenheimer: 'Positive TRILOGY 2 data could still enable approval for very high triglycerides. Irrespective of the audit outcome, we note several drug approvals despite mixed Phase 3 results (Roche/InterMune's Esbriet, MDCO/NVS's Kengreal). Additionally, should ACST's audit find that the five sites improperly followed protocol, we refer to cases in which the FDA has excluded invalidated data from submission packages (e.g. Takeda/Shire/NPS's Natpara).'