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It seems pretty self-explanatory. Good and bad news. Goldenberg hints at acceptance above expectations or at least not below expectations of LeukoScan for osteomyelitis in the German speaking countries, but the European FDA wants more info about when to use LeukoScan for appendicitis...what type of patients to use it on and under what circumstances.
From my first-hand knowledge of LeukoScan, having seen the studies and enrolled patients in the phase III trial, I am convinced that LeukoScan will replace WBC scanning (and gallium scans for infection) for any patient with occult infection. But IMMU better hurry up...Diatide's Techtide agent is only about 18 monts behind them (even if the images do suck). Just Friday, there was a patient who would have benefitted from LeukoScan had it been available. A baby with multiple prior surgeries with too many clips in his belly to make CT possible (the clips cause a streak artifact that degrades the CT images). It was decided that a Gallium scan was the best way to find the source of infection. Only problem, Gallium scans take 2-3 days to become diagnostic. LeukoScan would have given the answer in 4 hours, but it's not FDA approved. Remember that study: 100% sensitivity for patients who need surgery for intraabdominal infection).
Personally, I wish IMMU would stop f'ing around and sell themselves out to Mallinckrodt or some other company with the resources and know-how to exploit/utilize LeukoScan - and CEAScan for that matter - to its fullest potential. Also, if they're going to present data at large international meetings on new applications for CEAScan (ie, medullary thyroid CA), at least get someone on the stage who knows how to push a button on a slide projector (Forward vs. reverse does get confusing, I guess)....I digress. |
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