RE:Orphan Drug Status vs Fast Track Designation
Retailrube, the allowance of an orphan drug submission implies that there is an unmet need in whatever area the FDA determines has a current gap in treatment or impending requirement for a replacement treatment. In the case of MCNA we all know how effective, but incredibly toxic and intolerable the current standard of care is. As I read it, the criteria for Orphan Drug status is very similar to the criteria for a fast track that is or might be associated with the primary MCNA application for approval. Certainly an approval under orphan drug status does not mean that the full application will be approved but it is certainly a strong indicator of its likelihood and moreso its probability of being expedited. Going a step beyod that, the very fact that the FDA is allowing both submissions concurrently, without the need for further Phase 3 work should provide some comfort that the safety profile and associated efficacy meet or exceed the threshold for approval in both submissions.
I might not wait for the 25 cent mark to re load.