Wel there's this in regard to changes in FDA requirements for...

Wel there's this in regard to changes in FDA requirements for contrast agents.

"Given the importance of the contrast agent for successful deployment of the Optiscan devices, coupled with the regulatory changes, the Company has also been exploring options in relation to the supply and manufacture of the drug component of the combination (device/drug) suite of products. Optiscan has been Optiscan Imaging Ltd in discussions with drug manufacturers to find appropriate pathways to resolve the changes made by the FDA in relation to the regulation of fluorescein.

The Company expects to finalise its discussions with the FDA, allowing a clearly defined path to market, for both the InVueTM and InVivage® favouring a surgical use case, which fully accommodates the FDA’s feedback and the recent US legislative changes relating to contrast agents."