Aeterna Zentaris Inc.’s (AEZS) (AEZ.TO) Macrilen, a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency, which was denied FDA approval in November 2014, is tying its luck again.On December 30, 2017, we will know if the second time’s a charm for Macrilen.The FDA had declined to approve Macrilen in 2014 stating that the planned analysis of the Company's pivotal trial did not meet its stated primary efficacy objective as agreed to in the Special Protocol Assessment agreement letter between Aeterna and the FDA. The lack of complete and verifiable source data for determining whether patients were accurately diagnosed with AGHD was also another reason for rejection then.To address the deficiencies, Aeterna was asked by the FDA to conduct a new, confirmatory clinical study to validate Macrilen for the evaluation of growth hormone deficiency in adults using the insulin tolerance test (ITT), which the Company agreed to.However, the results of the confirmatory study, which were reported in January of 2017, came as a disappointment as Macrilen did not achieve equivalence to the ITT as a means of diagnosing AGHD.Despite the disappointing trial outcome, the Company resubmitted the NDA for Macrilen in June of this year, and is now awaiting the verdict.Will Macrilen make it to the finish line?AEZS closed Tuesday’s (Nov.28) trading at $2.10, up 1.94%.