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Ville

05/04/18 4:58 AM

#2174 RE: Ville #2172

Looking at the phase 2 data of Rolontis (n=36) and the phase 3 data of the first study i would like to see the superiority value for the phase 3 study.

With those values and n = 406 i think there could still be a chance to have met superiority in the first phase 3 study. They maybe just hit superiotrity and hold back this information til the second study hits, because they need to have superiority in both studies to have it in the label. Just a speculation.

EricHN

05/04/18 6:44 AM

#2177 RE: Ville #2172

Correct me if I'm wrong...it seems like the presentation at MASCC won't necessarily provide new information but will be a presentation of the ADVANCE study results, which they released on February 5th.

If so, that seems to mean it's neither good nor bad news. It doesn't provide data about the RECOVER study (and whether superiority is a possibility) but it also doesn't mean superiority is out of the cards because the original intention of the ADVANCE study was to provide non-inferiority, which it did.