worst corporate governance on the asx, page-101

• The US FDA provides the highest hurdle standard globally for the
approval of new drug and therapy treatments
• Approvals process is a detailed and lengthy process, involving
clinical trials over 3 phases and other FDA mandated requirements
• Onerous processed highlighted by the fact the FDA only approved
a total of 18 drugs last year
• US FDA approval process is a major catalyst for Value for Prima
Prima is in the final stages of its commercialisation timeline and will
commence its Stage III Pivotal Clinical Trial with the US FDA midyear
before seeking FDA approval to licence the product for
commercial use


http://www.primabiomed.com.au/projects/prodDocuments/PRR%20ASX%20Investor%20Presentation%2021April%2009.pdf