Replies to post #88140 on Biotech Values

[DewDiligence]

PSDV: Thanks for the confirmation in regard to the Hochberg correction for having two dosing arms that were compared to placebo.

The combined data from both A and B by modified ART showed 26.7% patients in the high dose, 26.1% of patients in the low dose gained 15 or more letters compared to 13% of controls and this was highly statistically with a p of less than 0.001.

One statsig trial plus a post hoc pooled analysis with a seemingly impressive p-value is not the same thing as two statisg trials!

If the indication in question were cancer, one statsig phase-3 trial plus a non-statisg supportive trial might be sufficient for approval. But DME is not cancer, and one can presume that the FDA will not be inclined to be lenient with its statistical analysis. PSDV and Alimera will need to show two statsig phase-3 trials to have a chance for approval, IMO.