There was no Phase 2 trial sanctioned by the FDA in 1999, with a patient population of at least 40. Instead what Lohr called a Phase 2 comprised of 8 patients receiving the exact same treatment.
Lohr used 1st line recently diagnosed patients. Not 2nd line patients. No control arm to show the presence of CIABs did anything.
Amusing was that two of the patients Lohr deemed to have a partial response died at 28, and 39 weeks. Whereas those with less of a response to the therapy (e.g. stable disease) frequently lasted longer. Of course the FDA wouldn't even notice such a thing. LOL
it can only work better...
Unfortunately Ifosfamide has little efficacy. There would be no better.
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