Friday, June 23, 2017 4:31:13 PM
Although post-approval benefits are significant, many early-stage companies apply for orphan designation when approvals are in the distant future. The successful application becomes public when the designation occurs, thereby broadcasting the young company’s intention and opening the category to anyone. Therefore, there must be another reason for these early filings. There is. Orphan designations are newsworthy and small companies often use the designation to put themselves on the map and to gain the interest of the investment community. Other benefits of orphan designation include:
Protocol assistance offered by FDA
Tax credits of 50% of the clinical drug testing cost awarded upon approval
Research grants—FDA awarded approximately 75 grants in 2013
Waiver of NDA/BLA application fee—this is a $2.2 million value
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