adam feuerstein: FDA: The CR/CRu data is not entirely reliable: 1. Small patient numbers. Data not robust. 2. Re-review of the patient data raises concern, especially since some patients were upgrade to a CR/CRu not none were downgraded. 3. No radiologic adjudication provided, which makes data unreliable. 4. 5 of 14 (36%) of CR/CRus in pixantrone patients occured in patients with ineligible forms of NHL. |