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BRIEF-CytoDyn provides update on combination therapy pivotal trial in HIV patients
October 13, 2017 / 10:24 AM / 2 months ago

BRIEF-CytoDyn provides update on combination therapy pivotal trial in HIV patients

Oct 13 (Reuters) - CytoDyn Inc

* CytoDyn provides update on pro 140 combination therapy pivotal trial in HIV patients following constructive meeting with FDA

* CytoDyn Inc - ‍interim efficacy analysis of primary endpoint to be conducted in coming weeks​

* CytoDyn - ‍FDA confirmed number, type of evaluable patients required for submission of BLA for pro 140 as a combination therapy​

* CytoDyn - ‍FDA accepted 40 patients currently enrolled in phase 2b/3 pivotal combination trial as evaluable

* CytoDyn - ‍FDA further agreed that data monitoring committee can conduct interim efficacy analysis of primary endpoint for pro 140 trial

* CytoDyn - ‍FDA confirmed 50 patients to be required to complete HIV drug trial, to allow flexibility in enrollment criteria for remaining 10 patients​ Source text for Eikon: Further company coverage:

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