You are the king/queen of spin. First off the FDA is not just a bunch of in house people who’re insulated from the outside scientific world; they’re a part of it. Dr. Pazdur for example relies on many inside and outside Scientists, Physicians, Statisticians, and Pharmacists to keep an integrated and highly even keeled up to the minute/state of the art process for approvals of Oncological treatments. He’s written tons of studies and is in fact expected to be reading Peer Reviewed Journal articles looking at trends and new perspectives and to guide the resources in a direction that the science is leading them to. So are all the people who serve on FDA’s Technical and Scientific Advisory Committees who are outside consensus experts in the field usually Physicians, Professors, Statisticians, etc. also. This trial will sure as shit be asked by the FDA to be looked at by an Advisory Committee because this trial is precisely what those committees are structured for. These are precisely the small group of people at the top of the field who’re constantly researching and reviewing new technologies. Before you throw yourself in front of the jury you want everything as clean and known as humanly possible because of what’s at stake here.
And yes, the FDA will have the raw data but you don’t know for sure that the Peer Reviewers for a Major Journal are not some of the same people who could be a part of an FDA Advisory Committee who will make recommendations regarding DCVax. You’re overplaying this “raw data” issue and you cannot make a blank statement that the Peer Reviewers are not also seeing raw data at all or that the FDA does a complete re-do of the raw data in some new way. The reason raw data is not normally part of a Journal’s Peer Review is because of the time it would take. However, if you look at the time from data lock one could easily imagine raw data may indeed have somehow been part of the review. Data is used in the SAP and this is standard stuff for reviewers and for the FDA. If there is a question with the SAP it would more than likely have been raised by the FDA by now. The questions of ‘how’ the SAP proves that the raw data correctly shows efficacy is what the FDA looks at most and tries to poke holes in the development of the SAP as related to the data and to see if the safety shown in the trials is true. When most people lived beyond expected I’m pretty damned confident that this is not remotely an issue.
So building consensus is not just to have people lined up on your side, it’s also to make sure before you file the BLA that your communication with the FDA during the initial phase is backed up by consensus experts because these folks are a small circle who’s influence on new directions being legitimized is not some giant secret. And it’s also no secret that these people all talk to one another and influence decision making because it’s part of the process I mentioned in my first paragraph above.
