On October 31, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) reported that the US Food and Drug Administration (FDA) has cleared the company’s IND application for the product candidate HyNap-Dasa (Press release, Xspray, OCT 31, 2019, View Source [SID1234649565]).

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Xspray Pharma’s Investigational New Drug (IND) application, for permission to produce materials for and conduct clinical trials with the product candidate HyNap-Dasa, was accepted for review on September 30, 2019 by the US FDA. The application has now been given clearance by the FDA’s Division of Hematology Products (DHP).

"We are very pleased that the FDA has cleared our IND application. This is yet an important milestone that validates both our clinical data and the development of our production method. The commercial production of amorphous material is already up and running in Milan and preparations for our upcoming ANDA application are proceeding as planned. This sends clear signals to potential commercial partners for HyNap-Dasa. With the IND-clearance at hand, we now look forward to being able to start our pivotal study with HyNap-Dasa shortly," says Per Andersson, CEO of Xspray.