Biotech Values

[DewDiligence]

PSDV:

However, the above refutes that assumption unless the standard ART analysis implies that there is no requirement to divide the p value.

PSDV’s use of the “ART” analysis in the PR is a lame attempt to mask the failure of the modified-ART primary analysis that was agreed to by the FDA. The ART analysis counts data points even when patients were receiving Avastin or Lucentis during the trial in violation of the study protocol! Such an analysis has zero chance of being accepted by the FDA as the basis for approval, IMO.

Please bear in mind that diabetic macular edema is not cancer, where bailout therapy following disease progression is a widely accepted (and ethically justified) policy because second-line therapy is generally thought to induce at most a small bias in the statistical outcome. On the other hand, in a DME trial for an implant such as Iluvien, giving some patients Avastin or Lucentis in an uncontrolled manner is apt to bias the results unduly.

If the FDA ends up accepting PSDV’s “ART” numbers as the basis for approval of Iluvien despite the fact that ART makes little sense and was not the prespecified primary analysis, I’ll eat my hat and never post on a biotech message board again!