Seeking Alpha's Brian Wilson believes Ampio Pharmaceuticals (AMPE) is on the fast track towards a 2014 FDA approval filing for the diabetic macular edema drug Optina.
He's wrong. Ampio's recent SEC filings paint a far more uncertain picture about Optina.
This drug [Optina] is being developed under a 505(b)(2) pathway, meaning that it can be FDA approved after completion of its current clinical trial. This is possible because of a FDA rule that would let Ampio use clinical trial data collected from other sources in its NDA, meaning that the company can utilize data supporting the use of danazol for other indications. The 450 patient Phase III trial is nearing completion, and should produce data in 2014 that will be usable in a submission for FDA approval...
In its most 10-Q for the September quarter, filed on Nov. 8, Ampio strikes all mention of Optina's development under the FDA's 505(b)(2) pathway.
The disappearance of the 505(b)(2) language is strange because in previous quarterly filings with the SEC going back to the middle of 2012, Ampio was quite adamant about reaching agreement with FDA on an accelerated clinical development path for Optina. Optina is a low dosage of the steroid danazol, which has been in use for more than 30 years.
For instance, this is how Ampio described Optina in its 10-Q for the March 2013 quarter:
The FDA granted Optina 505(b)(2) status in July, 2012, and we commenced enrollment in the clinical trial in February 2013. Drugs designated under this pathway can be approved on a single trial.