No sorry I am not WRONG. BY you posting the below proves nothing. I said all somebody has to do is prove to hold license/ownership of a drug/technology and show it may treat an orphan disease to get ODD. The drug/tech does not have to work!!
Think of ODD as pre approval for a loan/credit card. They're easy to get but when you aplly for the actual loan/CC and have to actually have to put in Verifiable info then it's a different story.
I've included a FDA link below for YOUR connivence. ________________________________________________________________________
SILVER SPRING, Md., March 16, 2015 (GLOBE NEWSWIRE) — PharmaCyte Biotech, Inc. (PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box(R), today provided shareholders with an update on developments on progress in its cancer and diabetes programs and at the corporate level. ________________________________________________________________________
FROM THE FDA; The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. 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 prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.
A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and 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.
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