Cel Sci Corporation (CVM)

[trickledownfacists]

John Cipriano – Sr. VP of Regulatory Affairs for CVM (Cel-Sci) and a former Deputy Director of the FDA….
“I would like to let you know that I have already contacted FDA, both the Division of Oncology Products, which is the group that will manage any application that comes forward, and the Division of Orphan Drug Products. Our product is an orphan drug, which means it affects under a certain population of patients in the United States. For that purpose sometimes it is advantageous to the review process, sometimes it will speed it up and helps us along.
and seek their approval to submit an application.
36:35 – And in my opinion, we should be successful in that. I think an application will be successful, that will be accepted by the FDA and the product will be approvable, for all of the reasons that Eyal outlined.”