Telios caught in FDA limbo

Among the many risks not under a company's control is the timing of FDA action on marketing applications. Although there are formal timetables according to which the agency is supposed to act, they are honored more in the breach than in practice. Companies with limited cash resources can find themselves caught in limbo between the uncertainty of FDA timing and the desire to continue development of other products. Telios Pharmaceuticals Inc. found itself in just such a spot last week, when the FDA finally indicated that it had questions it wanted answered before filing a PMA application submitted by the company last March for Argidene Gel to treat diabetic foot ulcers. The information request came more than seven months beyond the allotted time in which the FDA is supposed to make a decision on filing.

Company cutbacks ...