JP,
Your question seemed like a good time to address a topic that according to the mail I get , needs clarification.
The FDA approval you speak of means to me FDA approval for SMD trials that are slated to start first. The trial has not yet been started. IMO, we are looking at a couple years at minimum before an NDA(New Drug Approval) would be possible. I base this on an expedited review of Orphan designations being about half of the normal 5-7 years time for "regular trials and NDA approval". The safety and efficacy are all the same as other trials and huge challenges exist as only 16-17% of all trials(orphan and non-orphan) receive FDA marketing approval. What the sp might be that far out is nothing but a WAG...thanks
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