Monday, November 30, 2015 11:11:29 AM
Warsaw, 11.18.2015 (ISBnews) - Perma Fix Medical is focused on acquiring strategic partnerships with leading companies involved in the supply chain isotope Technetium-99 (Tc-99m) and plans that will submit applications for approval of its process for commercial use in the United States Agency for. Food and Drug Administration (FDA) and the EU office in early 2016 announced ISBnews CEO Steve Belcher.
"We are in negotiations with several potential strategic partners in the US and Europe. We expect that this partnership will be finalized and announced in the coming months. After finalizing these agreements, we will be able to produce the resin in our generator or use external devices manufacturers. At the same time we ready to submit applications for approval of our product to the relevant authorities in the US and Europe, "- said Belcher in an interview with ISBnews.
At the same time, the company is finalizing the test phase required to submit an application. "However, the main technical challenges are behind us. We hope that We will requests both the FDA and the office of the EU at the beginning of 2016. We plan to start selling or the first delivery of Tc-99m to our partner Digirad immediately upon receipt of regulatory approvals," - he stressed Belcher.
The basic source of income has come from the production of the resin in a mobile generator that enables the production of medical isotopes directly in hospitals or pharmacies that deliver to hospitals.
At the same time Perma Fix Medical is working on obtaining grant funds from the National Centre for Research and Development and is expected to receive directly receive approx. 800 thousand. USD consortium created to develop innovative generator Tech-99.
"We are considering a number of potential possibilities of obtaining grants from the European Union that will help us both to accelerate the commercialization of our production process Tc-99m in Europe and the development of our production and research capacity in Europe. Our priority is to launch the project of a new generator" - summed Belcher.
In an interview with ISBnews CEO also pointed out that Perma-Fix Medical will begin the process of transferring its listing on the main market of the Warsaw Stock Exchange alternative market NewConnect by the end of this year. The company also plans a dual listing on the Nasdaq.
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