Yes, I seem to recall that's how Dendreon managed it. In reality, the vast majority of the submission is the trial data that is probably already outsourced. But you can't outsource everything. The FDA wants direct contacts with the company. They like to build a relationship. It's about trust, if they don't trust you it will not go well. No single person or even handful of people can convey this much less manage all of the request for more information that will come. And every time a request for information is made the clock on a decision will stop. But then all of this is getting ahead of ourselves. Look at what Dendreon went through to get approval...I sincerely hope that isn't a model for NWBO's path....
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