They mentioned in the conference call that it was about as big a trial that could be organised - something like 5% of all the patients in the world. The real problem ws the patient population didn't match the trial plan - they certainly got lucky with the anti-bleeding effect as that data looks rock solid and the FDA is very likely to approve on that basis - in the end it doesn't matter why a patient is using your treatment as long as they are getting a benefit.
Ann: Presentation of BIT225-009 HIV-1 Phase 2 Data, page-580
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