Biotech Values

[DewDiligence]

AMGN/AGN—From the same PR:

The results ruled out inferiority compared to trastuzumab but could not rule out superiority based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response (pCR). The primary endpoint had a prespecified equivalence margin of +/- 13 percent and the observed upper end of the confidence interval was 13.4 percent.

For an FoB, going slightly outside the efficacy-equivalence boundaries on the positive side won’t be a problem for regulatory approval, IMO.

Note: AGN’s FoB program partnered with AMGN was not part of AGN’s recent asset sale to TEVA.