No.7
The review confirmed that the data generated in the ongoing 100-patient phase II study of IMMU-132 in 3rd line TNBC, which was fully enrolled in December 2016, can provide the basis for accelerated approval, subject to review by the FDA.
Furthermore, this review has led to detailed filing and manufacturing plans. Alongside the immediate focus on preparations for a BLA filing, Immunimedics will proceed with the final selection of a CRO to launch the confirmatory phase III study with the expectation of first patient enrolled in late Q3 2017, as well as executing on a manufacturing plan to build commercial inventory in preparation for a potential launch in the U.S. in 2018.
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