Oppenheimer notes Cellectar Biosciences (CLRB) announced receipt of feedback from the Scientific Advice Working Party of the European Medicines Agency that a submission of an application for a conditional marketing authorization, similar to the FDA’s conditional approval, in the EU could be acceptable for iopofosine-I131 as a treatment for post-BTKi refractory patients with Waldenstrom macroglobulinemia. This committee does not opine whether safety and efficacy are sufficient for approval itself. The firm sees the news as a substantial positive catalyst that should bolster Cellectar’s efforts to partner the iopofosine-I131 program. Oppenheimer has a Perform rating on the shares.
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