SeanJ1, re your question regarding ODP. I have the same question. There is no mention of official designation by the FDA in the News Release.

Here is a description of Orphan Drug Designation:

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit:
http://www.fda.gov/forindustry/DevelopingProductsforrareDiseasesConditions/default.htm.

Deke