Reported 2 days ago
RBC Capital has stated that Gilead's clinical hold on its weekly oral HIV treatment regimen will not likely impede the approval of lenacapavir for PrEP. Despite concerns regarding patient safety from earlier clinical studies, the firm believes the hold is manageable and does not foresee it delaying lenacapavir's PDUFA date. However, they acknowledge that the timing is not ideal, as it coincides closely with the approval deadline.
Source: YAHOO