Hey Rich, this is a direct quote from the SEC filed 8-k: " Other Events.
On February 25, 2013, Ampio Pharmaceuticals, Inc. (“Ampio” or the “Company”) issued a press release announcing that it’s Phase III clinical study of Ampion™ for the treatment for osteoarthritis of the knee will include a dose-escalation run-in study as recommended by the FDA. Our prior IND submission and FDA guidance suggested we would complete two Phase III studies (AP-003 and AP-004) with respect to Ampion™, each having approximately 800 patients. However, the formal guidance the Company received from the FDA indicated that the Company should conduct a dose ranging study “as a Phase II dose-escalation study or as a run-in study for one of the Phase III studies.” Now, as currently proposed in our revised IND, one of our Phase III studies (AP-004) will be conducted as a run-in study following the first study (AP-003A) with 320 patients. The size of the AP-004 study will be determined by statistical power based on the AP-003A study. The run-in allowance that the FDA has provided Ampio means that data can be presented anytime enough data is collected to support the hypothesis, which will allow for a rapid turn-around."
You can verify that by looking at SEC site. Seems to pretty clearly say there will be at least 3 studies (AP-003 and AP-004), Not sure how "The upcoming trial is a Phase III pivotal trial." makes any sense when the SEC document clearly says there will be two studies.
You are correct. There is still going to be the phase IIi trial but the FDa wants an additional study 'Run In" with the phase III study that will encompass 320 patients with the larger dose of 10ml.
I don't believe this will slow the phase III dow at all. In fact, it should reduce costs and time.
No IR job. The company gave the job to the youngster Rick Giles, who is the son of Richard Giles and Barbara Giles. Richard is a director and Barbara is an employee who I believe is like the controller.
It;s a huge mistake and one that is costing the company hundreds of millions in market cap because they are not effective with the investment community. A good IR program would have delivered the real story to a much broader segment of Wall Street ad would have certainly included big name bankers and analysts. This stock should be selling at $20 today and it is lagging for that very reason.
Pity for all the shareholders. The stock will eventually rise but it should be rising from a much higher base than $4.
Except for IR, management is great but no other company I know of is so removed from their shareholders.
They blame it on attorneys, but that is probably not the real reason.
It is indeed a pity they have fallen asleep in this arena and allowed the short interests to control their stock.
The FDA is allowing a modified (AP-003A) study with fewer persons for 4 weeks using two doses INSTEAD of the original AP-003 study. After 4 weeks the follow on study (AP-004) using the same people will be of a size determined and length determined by the statistical results from the first 4 weeks. Thus there is really only ONE study that is actually smaller in required size and duration that originally suggested. It is really all Phase III according to the FDA and the two original studies are actually combined. One can call it one or two. What really matters is using two different doesages makes it more likely that the statistical results will be significant and the more positive the results the shorter the last 1/2 of the study. Thus the cost to AMPE will be about 60% of what was originally estimated since instead of two seperate AMPE gets a smaller first part and a run on second 1/2.