Cytodyn Inc (CYDY)

[Amatuer17]

Actually the ODD does not speed up approval process - it gives few other benefits.(Breakthrough Designation expedites the process)

So they have to still follow normal trial and approval process


"Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a ...."

"information in support of their designation request. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies."

http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm