Please read the following from the FDA regarding FDA Orphan Designation, I also believe that HemaXellerate is considered a biological product in this repect:
Also important are the grants and tax benefits for Orphan drugs: The OOPD administers two extramural grant programs. The Orphan Products Grants Program provides funding for clinical research that tests the safety and efficacy of drugs, biologics, medical devices and medical foods in rare diseases or conditions. The Pediatric Device Consortia (PDC) Grant Program provides funding to develop nonprofit consortia to facilitate pediatric medical device development.
What you get from FDA Orpan Approval:
- 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 Soruce: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM311928.pdf
If HemaXellerate is approved as a FDA Orphan treatment/drug, we should be able to receive a grant for the clinical trails of HemaXellerate.
In the PROSPECTUS, Regen BioPharma believes that HemaXellerate qualifies as shown below:
The Company believes that this application of HemaXellerate qualifies for Orphan designation under the Orphan Drug Act due to the fact that aplastic anemia is a rare disease with prevalence in the United States of less than 200,000 and intends to apply to the FDA for Orphan designation for HemaXellerate.
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