FDA lifts hold on Green­wich Life­Sciences as biotech will forge ahead with im­munother­a­py drug can­di­date

While the bear mar­ket still has its hold over the biotech sec­tor, Green­wich Life­Sciences is wel­com­ing the lat­est news from the FDA.

The biotech an­nounced Tues­day that the FDA has re­moved the clin­i­cal hold on a Phase III tri­al for GLSI-100, an im­munother­a­py in HLA-A*02 pos­i­tive and HER2/neu pro­tein pos­i­tive sub­jects who are at el­e­vat­ed risk for breast can­cer re­cur­rence. With the hold lift­ed, reg­u­la­tors are al­low­ing the piv­otal tri­al, dubbed Flamin­go-01, to pro­ceed.

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