Amarantus Bioscience Holdings Inc (AMBS)

[blackhawks]

Now you should post the FDA orphan status guide so everyone can see how much easier it is.

Here is something to think about... You sure MANF is even classified as a drug.....

Reponding to your post reminded me of this scene:

http://www.google.com/search?sourceid=navclient&ie=UTF-8&q=woody+allen+and+marshall+mccluhan


In this case I'll let the FDA and Amarantus serve as M. McCluhan for your statement and question.

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm

"The approval of an orphan designation request [i]does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and efficacy of a compound must be established through adequate and well-controlled studies."


http://www.amarantus.com/about-us.html

"The Company is currently focusing on the development of its lead drug candidate AMRS001 for Parkinson’s Disease and Cardiac Ischemia." (read more – AMRS001)