Would the FDA say OK to the CMC ? That will come only with approval. It would be like the FDA saying "give us more data and we will give approval" not knowing what that data would look like.
My reasoning to giveing compasionnate use through a registar is that data could be used as the data the FDA asked for. Would it be all that is needed? I don't know, The FDA wouldn't know. No one would know untill the data starts to come in. Do we have anything to lose.
"Time" So important , on many different levels.
Lives first, finance and regulation.
Lets go SI !
Why a trial?, page-48
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