As my previous post got moderated here is the summary:
Orphan drug designation certainly comes into play with EMD AML. This provides 7 years post-approval market exclusivity even if you don't have patent protection (it is 10 years in the EU). Orphan drug designation is less important these days with the new peripheral formulation which has IP protection for 20 years (assuming the patent is granted).
Ann: Positive Pre-IND Guidance from FDA on Zantrene, page-31
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