Posted by Michael Wonder on 28 Jun 2021
Technegas receives complete response letter from the US FDA - requirement to address outstanding technical elements
28 June 2021 - Cyclopharm announces that the US FDA has provided a complete response letter for the new drug application for Technegas.
The US FDA has determined it is unable to approve the new drug application for Technegas in its present form and has provided a definitive list of items and recommendations for outstanding elements to be addressed within a 12 month period.
Cyclopharm expects to resolve all these elements with a view to securing approval for commercial sales of Technegas in the US market in 2022.
