Tuesday, December 21, 2010
Aeterna Zentaris Inc., of Quebec City, reached agreement with the FDA on a special protocol assessment for its ongoing Phase III trial of Solorel (AEZS-130, macimorelin) as a diagnostic for adult growth hormone deficiency. The original comparator diagnostic in the Phase III trial was withdrawn from the market, necessitating modifications to the trial design. Aeterna Zentaris expects to complete the trial and file for approval next year.
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