Thursday, March 16, 2017 4:27:59 PM
At the end of the year, we had approximately 12.9 million common shares outstanding. During the first quarter of 2017 to date, we raised an additional $1.7 million of net proceeds using our ATM program. And we now have approximately 13.5 million common shares outstanding.
After year-end, we reported top line results from our confirmatory Phase 3 study of Macrilen for the evaluation of Adult Growth Hormone Deficiency or AGHD. We were disappointed by the top line results as we failed to meet one of the co-primary endpoints of the study.
However, our disappointment soon gave way to optimism, as we evaluated the full data from the clinical trial. We concluded together with our panel of independent experts that Macrilen works even better than we had expected. And that it demonstrated performance that we believe is supportive of achieving registration with the U.S. Food and Drug Administration.
We will discuss the results of the clinical trial in our conclusions with the FDA at the end of March. And hope to have a timely decision regarding the future of the development of this drug. If the FDA agrees with us, we expect to be able to file the NDA or new drug application early third quarter, and if it is approved begin commercializing the product in first quarter of 2018.
Recent AEZS News
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