$AGRX All, @Clinton0 and I were in the middle of the crappy BD that the FDA released end of Oct (2 days prior to the ADCOM). It created a panic and the stock tanked from $1.2 to .3’s. Both of us had large positions and were extremely stressed. We reviewed the BD in detail and agreed they were going off old data....which played out in the ADCOM and we received a 14-1 recommendation for approval! I’ve seen several fear mongers keep bringing up the pearl index and I asked @Clinton0 to address it. Here’s a repeat of his post. 1. BMI and Pearl Index? Some of you may remember if you watched the Adcom, a PI of 5 will make no difference in terms of approval, as it is understood that Agile will more than likely have an LOU 202 lbs, which is typical of CHC patches, for example, Xulane, 198 lbs. The FDA is working closely with Agile regarding post marketing studies in order to better define the new standards by which the PI and efficacy will be defined.
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