It was found in the 10-K under Phase I "Clinical Development Pathway" with a direct quote as "During 2013, we decided to switch Ampion to an acute label as we believe that this would be a more efficient and effective pathway to regulatory approval and require us to expose Ampion to few than 1,500 patients."
I read some of the he report and there are a few things that concern me. First, Ampio changed the study from a Chronic managing condition to managing an Acute pain situation. Therefore, it would be easier to get approval of something that manages acute pain, than trying to get studies that show an ongoing management of long-term pain. This changed the focus and condition of approval. Therefore, there could be an adjustment to the population of those administered the injection. Second, the company has been creating a physical plant for the production of Ampion that isn't yet approved. This expense to create a building or campus is under the 'anticipation' of an FDA approval that may or may not happen. Third, The company seemed to say that they are too busy with this current study to even comment about the other study they are involved with. Finally, the report indicated a number of times in bold type, large type, various fonts that nothing may come of their studies and nothing is guaranteed. Therefore, since the announcement of some trial data might support approval, it's not really ground breaking yet. It seems to work much better than placebo or saline. However, the question is whether it will be approved just for acute pain situations, or whether it can be used safely for long-term use - years.