Coincidentally, Ampio just happens to have a solution to the problem. It has 6-week interim data from its ongoing Phase 3 trial evaluating three injections of Ampion for osteoarthritis of the knee. Patients improved 86% on pain score and 87% on function score. Its August 18 press release refers to the data as "very positive" results.
The company says that it is meeting with its regulatory advisors about the feasibility of substituting the multi-injection data for the singe-injection data in its BLA submission.
AMPE share are down 19% premarket on robust volume.