The five dropouts in the placebo arm could be the reason for the low placebo rate. They discontinued the trial probably because they had severe OM. Maybe Leo will provide some explanations when the secondary endpoint is available. KMBJN made some good comments on dropouts here.
I understand why interim data raised people’s expectations. Come to think of it, bad timing could be the culprit. Here’s what I mean. Let’s assume in the B-OM arm, patient 1 didn’t have severe OM and patient 2 had severe OM. If patient 2 was enrolled before patient 1, patient 2 would be included in the interim analysis and patient 1 would be excluded. Then the interim analysis would look like this.
Incidence rate - 3 out of 9 patients (33.3%)
The top-line data would still be the same.
Incidence rate - 7 out of 19 patients (36.8%)
But it’s a lot closer to the interim %. That’s why interim analysis can be a double-edged sword sometimes. Hope I make sense.
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