Marzan, this is how I see it. I may not be totally correct but believe I got the gist of it. A SAP was created around the time they started the P3. It gives guidance on what stats and calculations you want to do on the data and endpoints. For instance, how much alpha spend to use on your primary and secondary endpoint, or if you want to remove an endpoint like Halozyme did by replacing the Primary endpoint which was PFS w OS and in their case giving all the alpha spend to OS. Or there was discussion on this board that there was a better calculation for OS to take into account crossovers. Per standard procedure, at least that’s how Halozyme described it, if they now want to change their SAP they need to get RA buy in. Halozyme did that by setting up a meeting w the FDA and using guidance from the meeting minutes in their revision. I documented this in post 201346 and associated posts.
Edit - It took them 4 months and change for Halozyme to get this done. Getting buy-in from 4 RAs, I can see NWBO taking longer but they'll at least be able to have these meetings w the RAs independently, and in parallel, for the most part, but what happens if their is disagreement between the various RAs? Anyhows, I would think this process of meeting w the various agencies has started already. I'm hoping this is all straitened out by the time ASCO rolls around. At least I give it a puncher's chance of that happening.
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