PharmaCyte Biotech Inc (PMCB)

[frosr6]

Needs FDA DRUG APPROVAL. PMCB does not have FDA approval of Ciab ONLY ODD. There's a difference. Pmcb would have to go through all required trials AND then get FDA approval. Think that can happen by end of June when patents expire? Me neither.

"Seven-year marketing exclusivity to the first sponsor obtaining FDA approval of a designated drug"


"Orphan Drug Status Orphan status does not mean that FDA has approved the drug. Orphan status and FDA approval are not the same. The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Sponsors must establish safety and efficacy of a compound to treat a rare disease through adequate and well-controlled studies."

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM311928.pdf