Diagnostic Could CSCI get a milestone payment for the pediatric diagnostic from existing licensees in the near future? How aggressivly have they marketed the product to date without the ability to sell to children? How compelling will the childhood data be? The pediatric trial is also designed to test the product as a standalone test. Currently two tests are required to confirm a diagnosis. In addition to a new North American deal CSCI is also pursuing deals in Asia and for the rest of the world. Countries like China largely only test for pediatric growth hormone deficiency.
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Macimorelin Commercialization Program
Macrilen® (macimorelin), is the first and only U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency (“AGHD”). Macimorelin is currently marketed under the tradename Ghryvelin® in the European Economic Area and the United Kingdom through an exclusive licensing agreement with Pharmanovia. To date the product has launched in the United Kingdom, Sweden, Denmark, Finland, Germany, Netherlands and Austria. More EU countries will follow pending re-imbursement negotiations. The Company’s several other license and commercialization partners are also seeking approval for commercialization of macimorelin in Israel and the Palestinian Authority, the Republic of Korea, Turkey and several non-European Union Balkan countries. The Company is actively pursuing business development opportunities for the commercialization of macimorelin in North America, Asia and the rest of the world.