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I thought we already completed the phase 3 trial for mono with great results. Our goal was a label extension after we achieved combo HIV approval

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Monotherapy CD03 was a trial with no comparator arm. A phase 3 double blinded, placebo controlled trial needs to be done in monotherapy in order to get a label extension. All of this because the FDA wanted a combo trial done before we could get a green light on a pivotal monotherapy trial. Which was BS because the placebo arm would have been with HAART therapy so no harm would come to those patients as a result or none more than the HAART they were already taking would have done.