AspenBio will likely release results from the phase III study of its AppyScore appendicitis blood test in June, around the same time the company plans to re-file for AppyScore's approval with the U.S. Food and Drug Administration, according to AspenBio Vice Chairman Greg Pusey and CFO Jeff McGonegal, both of whom spent some time talking to me this week.
It's easy to file for FDA approval, convincing FDA to grant approval is a bit more difficult. AspenBio knows this well because the company pulled AppyScore from the FDA's medical device review process last year, choosing instead to conduct a new clinical trial and resubmit.
McGonegal insists that there was nothing wrong with the data from the previous phase III study of AppyScore; the company merely felt that it was quicker and faster to run a new clinical trial rather than try to answer FDA's questions with data from the old study.I must say, that answer had my head spinning a bit. AppyScore demonstrated a negative predictive value of 83% in the old phase III study, which was well below expectations.
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