hi jack1510
what I recall reading (and from direct discussion with MR) is that they will go into phase IIb/III trials almost similatenously or at least phase IIb will quickly roll into phase III trials. Also the phase III trials may well be cut down in size in terms of number of patients (may be only 60/65 are needed) and endpoint criteria. Also he told me that once the IND approval is in (should be by Q4), then Orphan drug status will come automatically (which would allow for the reduced phase III trial).
planet
when ann. will available?, page-24
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