Thanks for the responses on my SPA question. So from what I gather from the information posted the significance revolves around clearly establishing the efficacy in the Phase 3 trial because this is a "new" drug and to minimize the risk that addition trials past phase 3 will be necessary in order to convince the FDA to provide final approval. So I guess it is a "special" protocol but not "out of the ordinary".
Once again Leo proves to be a deft CEO. He is using the expertise of the team he has built (I'm thinking he's leaning heavily on Dr. Trust) to continue to work within a difficult and complex FDA process find ways to minimize risk of failure and to lay the ground work for expediting B to approval. Take that all of you bashers!!! IMO, Leo Erlich will be recognized as one of the top biotech CEO's in the nation within the next few years.