I'm pretty sure the test was already done before this last cc.
The ANDA represents the second filing for a product co-developed with SunGen under the SunGen Agreement. According to IMS Health data, the branded product and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017. The Company received a request from the FDA for additional information to which the Company has responded. The response is under review by the FDA.