Ampio Pharmaceuticals (AMPE) completed a clinical trial of its diabetic macular edema drug Optina in November, but it is just too busy to disclose results.
I'm not kidding. Ampio filed its annual report with the Securities and Exchange Commission on Tuesday with this gem tucked inside:
At this same time, our scientific and regulatory staff and our CRO were fully engaged in completing the Ampion STRUT and STRIDE clinical trials, it was decided to retain their focus on that effort rather than divide their attention. Once the Ampion clinical trials are complete and the outcome data reported to shareholders, management focus will be shifted back to compiling and reporting the Optina clinical trial results.
Hmm. Let's back up for moment and recap Ampio's bizarro backtracking on the timelines for the Optina diabetic macular edema clinical trial. Ampio initially promised results from the Optina trial in the third quarter of 2014. Later, the analysis was pushed back to the fourth quarter because Ampio decided to enroll fewer patients than originally expected. (Shouldn't enrolling fewer patients accelerate the time to final analysis? Not at Ampio, where logic goes to die.)
Ampio admitted the shortened Optina study was completed in November, but analysis of results couldn't happen until after the company met with the Food and Drug Administration. The meeting couldn't be scheduled because of Christmas, and so, yup, another Optina results delay. (Why did Ampio need to meet with the FDA prior to analyzing results from the Optina trial? That's never been explained.)
Which brings us to the present. Ampio employees are "fully engaged" dealing with studies involving the company's other pipeline drug, a knee arthritis drug known as Ampion. There is just not enough time in the day to take a look at the Optina data and report results.