Navidea Biopharmaceuticals Inc (NAVB)

[DewDiligence]

kaiva: There was a lot of detailed info on today’s CC. If you didn’t listen live, the replay access number is in today’s PR.

It’s clear that the company has considerable work to do to reactivate RIGS. Given the way the FDA typically performs statistical analyses, there may be an added statistical burden here to account for patients whose records cannot be located. Further, the FDA will require proof that the company can manufacture a product that is bioequivalent to what was given to patients back in the 1990s. (This would be the so-called “bridge study” that David Bupp mentioned in a recent webcast.)

There is an impressive upside if everything clicks, but I plan to take the cautious approach of waiting for guidance pursuant to the company’s April 15 meeting with the FDA.

--
Also from today’s CC: there were about 51M shares outstanding at 12/31/03 and about 15M options/warrants, many with exercise prices of 50 cents or less. For valuation purposes, one should assume that all options/warrants will be in-the-money, which gives an effective share count of about 66 million.