fum8 Nov 2019 13:31
ve reread this from the previous RNS ,it looks like they are doing more than they need to to get this over the line , it does seem to come over with great confidence
A 12-month open-label extension study to assess long-term safety and tolerability of a drug is a standard regulatory requirement for drugs intended for long-term treatment of non-life-threatening conditions, such as ED. In line with advice received from regulatory authorities, Futura has designed an OLE in which subjects recruited from primarily high patient volume countries are invited to enter into the OLE on the 0.6% dose a few days after completing the double-blind phase and follow up visit of FM57. In OLE studies, generally 300 to 600 patients are evaluated for 6 months and at least 100 of those patients for 12 months; defined by the International Conference on Harmonisation (ICH) guideline E1. Therefore, to meet this requirement, Futura are pleased to announce that 450 subjects from the double-blind phase of FM57 have agreed to enter the OLE study. As previously reported on 11 September 2019 interest in patients electing to enter the OLE remained high having completed the double-blind phase of FM57.
anyone know how long the results usually take i know they said december but is it possible before that