Replies to post #2037 on Navidea Biopharmaceuticals Inc (NAVB)

[sts66]

"There will be people supporting Shrkeli's thesis that they should compare seek to VBD and SC, now that both are approved, especially since VBD and SC were standard of care even before yesterday's announcement. Second, that means that a new trial MAY be wanted by FDA. "

From everything I've read, which is plenty, you cannot do a direct VBD/SC comparison against LS - since both are radioactive tracers, you can't give the same patient both, you'd have no way knowing which tracer you were picking up heat from. And since these women ARE HAVING BREAST CANCER SURGERY, you surely can't propose to do two consecutive surgeries on them to see if LS would find something missed by the other combo.

It's one or the other, period. Attempting to do anything else would be morally and ethically indefensible. Assuming LS is approved (and Pharmalucene sure seems to think it will be), which one would you want to be forced upon you as a patient? One that could potentially kill you with anaphylactic shock or one with no known side effects?

[invest2win]

Great job summarizing it all up. It's nice to see a realistic view. You cannot always find that here. Sometimes we need to take a look at both sides of the story pro and con. It's not always a rosy picture like we'd like it to be.

[kelseyf]

Nice summary and opinion points but you do not address a couple of important points of the of this FDA approval; it limits the SC tracer to only breast cancer.

Where as NEOP is going after a much broader FDA approval and application also the safety and after affects issues comparing SC to NEOP lympo.

Kels

[Fenix1357]

In addition to establishing the clinical effectiveness of the indication, the Pharmalucence study consolidated information regarding SCI preparation parameters including injection volume and radioactive dose as well as describing performance stratified by injection site. Safety data related to the subcutaneous injection route were also collected. Related recommendations are included in updated drug labeling.

This may have nothing to do with NEOP.

Another angle to consider is whether Pharmalucence has established FDA approval only for its own proprietary brand of sulfur colloid so as to establish market exclusivity for its own brand of sulfur colloid. A similar story happened with another medicine used in Obstetrics and once the co. got FDA exclusivity raised its price several fold.