FDA Grants Orphan Drug Designation, page-19

Thanks to all above responding to the question; I agree that it indicates that the drug is not an approved Orphan drug in terms of marketing, but that the Orphan drug designation is granted. As an aside I wonder if there is any dispensation for continuing the release of the drug to those that were on it during the trial? Seems only fair, but fair isn't necessarily a prime concern in these matters, but given the safety profile...well...it seems fair.

Ajostu, if the FDA posted to their site that the designation was granted on 11/02/2015 as indicated, I would have thought that the Neuren team would have been advised on Thursday or Friday last week our time, enough time for a release to market about Orphan status. Which had me wondering about BTD being known and combined into a single release - pure speculation of course. But who knows - people could be in transit, there may be protocols that control communication to certain timelines and response cues.

Very interested to see a release on Monday, would almost have to arrive pre-open you'd think...

Thanks again to all who responded...have a great Sunday.