Navidea Biopharmaceuticals Inc (NAVBQ)

[drbio45]

My take on the neop meeting

the most bullish scenario would have been that the FDA said get the survival data from the last trial and if results look good it will be approved but you need to do a bridging study of about 70 to 100 patients to make sure your manufacturing batches today work the same way they did 7 years ago.

The fda didn't do that. According to Bupp the FDA will use the prior trials as a first phase 3 trial and he needs to do another confirmatory trial which is what usually has to be done to get a drug approved. What Bupp didn't make clear in my opinion is that the drug can be approved as a diagnostic in a very short time once he starts enrolling. Since he already has shown that finding the additional tumors because of the use of the Rigs product leads to better survival I believe the drug's approval as a diagnostic will cause it to be used as a standard of care before the prognostic approval is attempted.

The coach of the Jersey Devels is undergoing colorectal cancer surgery this week. If the option was given to him, would he prefer to be taken off the operating table after the surgeon thinks he removed all the tumors, or would he rather have the surgeon do the surgery and then scan the area with the geiger counter to make sure all the tumors are gone.

I know what I would choose, but I guess no one in the meeting from the fda needed colorectal cancer surgery.

Another bad decision. I could see it if the drug had a lot of toxicity,but the side effects of the drug are benign if anything, why not approve it.

The stock got hit because people were looking for the most bullish scenario. With 60 million shares and a 70 cent price you are paying 42 million for a company with a potential billion dollar drug 2 years from approval (rigs), a potential 150 million dollar drug a year and a half to 2 years from approval (lymphoseek), and a profitable medical device business that should probably be sold so they don't have to raise cash to do the clinical trials.

The stock is cheap at this price.