FDA approval of the generic version of Temodal (Temozolomide) must be getting reasonably close by now. A distribution agreement is already in place with Mayne Pharma's USA division. Also some of the 23 generics recently purchased would now have had trial/stability batches manufactured at Boronia to satisfy the FDA requirements to for transfer to the new manufacturing site. I think they need 6 months of stability data before they can submit the application so expect approvals before end of 2015.
Temozolomide is the key one for me to give the share price a real uplift as Mayne Pharma ability to penetrate the market has been given a boost through their recent acquisitions in the USA and the setting up of a new specialised and experienced marketing group.
Price Catalysts, page-2
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