worst corporate governance on the asx, page-100

The trial can starts 30 days after the IND has been submitted to the FDA if the FDA does not contact Prima within the 30 day waiting period. Phase11b/111 Pivotal Trial.


Read page 3 and page 6

http://www.innovation.org/documents/File/Adaptive_Designs_Presentations/14_Maca_Adaptive_Seamless_Designs_for_Phase_IIb_III_Clinical_Trials.pdf


"Mr Rogers will also meet with the Company’s key medical advisers in the US, Dr
Joyce Frey-Vasconcells and Dr Heidi Gray, to progress Prima’s Investigational New
Drug (IND) application with the US Food and Drug Administration (FDA) and its plans
for the Phase IIB/III Pivotal Trial. The granting of Investigational New Drug status is a
pre-requisite for all new drug applications seeking FDA approval for
commercialisation, and is one of the final milestones to be completed by Prima in the
commercialisation process for CVac™."


http://www.primabiomed.com.au/projects/prodDocuments/PRR%20ASX%20%20North%20American%20investment%20patners%2011%20May%2009.pdf