Regen BioPharma Inc (RGBP)

[LaddyMan]

GREAT NEWS ALL. But longs knew it was coming.

For everyone's enlightenment, since some here continue to misrepresent the facts:

Misconception #4. The orphan application process is arduous

Actually, the orphan application process is quite simple. In the US, the argument hinges on disease prevalence of under 200,000. If the number can be established and there is a “scientific rationale” for the use of the drug, it will most likely achieve orphan status. Unlike most other FDA submissions, we often urge our clients to file rather than continuing a lengthy internal debate. If FDA rejects the submission, FDA will explain why and the submission may be reworked and refiled as many times as necessary. Additionally, there is no FDA fee for the orphan designation request.

Just to make sure everyone has the FACTS.

http://www.pharmaceuticalcommerce.com/index.php?pg=opinion&articleid=27143

RGBP