Nubes, "catalysts" are far from over unless you mean very short term, including EMA approval for LS (filed last December), EU partnership, and further good news from the P2b NAV4694 study was just announced:
Navidea Biopharmaceuticals Announces that Results of NAV4694 Clinical Trial Published in the Journal of Nuclear Medicine Last update: 4/18/2013 1:40:00 PM -
Head-to-head comparison of NAV4694 and B-Amyloid imaging gold standard in Alzheimer's disease and dementia - DUBLIN, Ohio, Apr 18, 2013 (BUSINESS WIRE) --
Navidea Biopharmaceuticals, Inc. (nyse mkt:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the peer-reviewed publication of results from a clinical trial of NAV4694 in healthy subjects and those with diagnosed forms of dementia. The trial assessed the performance of Navidea's Fluorine-18 labeled amyloid imaging candidate, NAV4694, in a head-to-head comparison with the acknowledged benchmark, gold-standard amyloid imaging agent, (11)C-labeled Pittsburgh Compound-B(PiB). Results demonstrated that NAV4694 displayed imaging characteristics nearly identical to those of PiB and the authors believe these results show that NAV4694 may be useful in the early and differential diagnosis of Alzheimer's disease (AD). The study, "Head-to-Head Comparison of (11)C-PiB and (18)F-AZD4694 (NAV4694) for B-Amyloid Imaging in Aging and Dementia," was published in the current online edition of the Journal of Nuclear Medicine and will appear in the June print edition [J Nucl Med 2013; 54:1-7 DOI: 10.2967/jnumed.112.114785].
B-Amyloid imaging has the potential to play an increasingly important role in clinical practice as revised criteria for the diagnosis of probable AD allow for earlier diagnosis and therapeutic intervention. "For this to be a reality, clinicians will need access to reliable, practical and affordable imaging options," said Professor Christopher Rowe, MD, FRACP, Director of the Department of Nuclear Medicine and Centre for PET at Austin Health, Melbourne, Australia and one of the authors. "This study suggests that NAV4694 images may be more easily and reliably read in clinical practice than other F-18 labeled PET tracers. By displaying imaging characteristics nearly identical to those of the gold standard, PiB, NAV4694 provides the same low background needed for earlier differential diagnosis while affording the practicality needed for production logistics."
I agree the shorts currently have a stranglehold on the pps, but they can't hang in there forever - LS will be the new gold standard for solid tumors and sentinel node designation within the next 12-18 months - for all practical matters, it already is, but word needs to spread via education and sales need to ramp decisively.
Interviews with LS aware oncologists/surgeons indicate they can't wait to get their hands on it, and the H&N trials were so superior they were halted early by the safety monitoring agency, as it was deemed unfair for the control group to not receive LS - avg of 43 lymph nodes removed in control vs. only FOUR per patient in the LS group - that's frigging unbelievable! Beyond the extra surgical complications associated with removing that many lymph nodes, the ones in the head and neck provide crucial immune system support - as in the human body exists as it does for a very good reason - removing lymph nodes is not desirable from an overall health standpoint, so minimizing how many are removed while still getting that critical sentinel node out is a REALLY BIG DEAL.
Lastly, Cardinal Health has finally rolled out LS for sale:
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