Monday, June 17, 1996
WASHINGTON - Based on phone calls to BioCentury last week, readers were wont to second-guess the deliberations of the Central and Nervous System Drugs Advisory Committee on Genentech Inc.'s Activase and Cephalon Inc.'s Myotrophin.
Their questions included:
Why did the panel on one day reject the results of a European trial for Activase as unimportant, and then the next day dwell on the European study for Myotrophin?
And in any case, was the committee really concerned about the European trial of Myotrophin, and will FDA "really" refer the drug's NDA to the committee again?
In a nutshell, the committee's interpretation of the significance of foreign study data was based on the degree of similarity in the companies' protocols for the European and North American trials. Trial design, not geography, was the important variable.