With discussions already "ongoing" and set to conclude in the next couple of weeks I have to believe we are past the point of proving, or digging for, efficacy. We should be in the final stages of how to roll this out and discussing/finalizing things like prioritization of vials for who and what facilities, distribution coordination with American Regent, and negotiating/coordinating on everything that goes into the labeling (sites of injection, instructions, indication, adverse event tables, contraindications, etc.) to make sure that everything is known, recorded, and available for healthcare professionals as they begin injecting patients. The FDA is too slow to be still digging around our data for possible effectiveness if these timelines are to be believed. The Prescribing Information (PI) included with each prescription are basically the full story of the drug from trial results all the way down to chemical formula. It's intense, the amount of information packed onto a page or two in 1pt font. My best is it's all of that stuff being worked on together so it's complete and the FDA feels comfortable releasing it to market.