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However, none of the studies reported on hematological or clinical outcomes

5FU-resistant HCT116 cells were generated by chronic exposure to 5FU

there is no multicenter Phase III dataset

Pocate-Cheriet K, Santulli P, Kateb F, Bourdon M, Maignien C, Batteux F, et al

With respect to the substantial similarity criteria, the applicant believes that CYTALUX is not substantially similar to other currently available technologies because there are no other optical imaging agents with the same active ingredient, nor the same mechanism of action for the same indication of ovarian cancer, and that therefore, the technology meets the newness criterion