It's just a fact Dr. Fisher screwed up the earlier rabbit trials (no PET scans in the first critical 10 days post application) and made bogus containment claims he couldn't backup. The work had to be repeated at JHU Vet school as a result, and apparently that didn't go well either. Why else did MK have to pull his fubared IDE application last year before FDA could reject it? Here we are a year later and MK is again making bogus safety claims based on a few patients in India that apparently received watered down product. How else do you explain tumors surviving treatment?
Maybe IDE is approved this time, but MK has again managed to give FDA a boatload of reasons to say no. Time will tell. All should be prepared for the worst.
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