Navidea Biopharmaceuticals Inc (NAVB)

[RMD1]

Manufacturer...this is from the 10Q

Upon the submission of the IND and draft Phase 2 protocol, FDA advised Navidea that commercially-produced Lymphoseek would need to be used in the Phase 2 clinical study, as opposed to using drug previously manufactured in laboratories at UCSD. Navidea transferred bulk drug manufacturing to Reliable Biopharmaceutical Corporation (Reliable) and engaged OSO BioPharmaceuticals Manufacturing LLC (OSO Bio, formerly Cardinal Health PTS) for commercial manufacturing of the drug product.

I know they did a 10 year manufacturing contract with Reliable in 2009. So, either Reliable, or OSO ( was Cardinal) is responsible. Just doesn't make sense. Reliable specializes in API, OSO does the rest. They have been working with the FDA for years. I cannot believe this would be something major. They are working with manufacturers that already do this type of work.