Replies to post #22096 on PharmaCyte Biotech Inc (PMCB)

[bulldurham]

it's not confusing...first they apply for orphan drug status and when they receive that they have access to the grants...

Incentives Orphan drugs are desperately needed by patients with rare diseases. The
ODA provides for granting special status, orphan drug designation, to a product to treat a
rare disease or condition upon request of a sponsor. The product to treat the rare disease
or condition must meet certain criteria. Orphan designation qualifies the sponsor of the
product for:
- Seven-year marketing exclusivity to the first sponsor obtaining FDA approval of a
designated drug
- Tax credit equal to 50% of clinical investigation expenses
- Exemption/Waiver of PDUFA application (filing) fees
- Assistance in the drug development process
- Orphan Products Grant funding

bull