Submitting an orphan designation request is unrelated to the drug approval process. In fact, the orphan application can be filed anytime in the drug development process before NDA/BLA submission, even prior to IND filing.
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 LINK
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