Dear Nelson, I appreciate you so much for your great helps in preventing HIV and give us nice consulting¡CCurrently we know Ibalizumab has been gotten the breakthrough and orphan drug designation for medications¡Ahowever¡Ait still need to be performed the Phase III clinical trials¡CDo you know when the drug can be approved by FDA to rescue so many HIV patients with multiple drug resistance?
Ibalizumab is a research monoclonal antibody that blocks one of the receptors on the CD4 cell. The salvage activist community has met with Taimed and its predecessor for the past 13 years that this product has been studied.
As you say, ibalizumab (IV) now has not only orphan drug designation but also breakthrough therapy designation. This is the first time that a HIV treatment has received orphan drug resignation. Both of these designations will help to get the drug approved more quickly due to a lower required number of patients to enroll for phase 3.
It is difficult for anyone to predict approval of a pre-phase 3 drug.
The company is currently meeting FDA requirements to proceed for accrual of their upcoming fast track phase 3.