RE: RNS & GL interview9 Aug 2018 09:16
Morning Rebarm,
Yes worth another listen.
Really think some have missed the importance of yesterday’s news.Basically whatever Iclaprim sells or is worth it effectively e tends the protection vs generics by 80% in ABSSSI in US the biggest addressable market and hence an increase in valuation.
The FDA not only led the idea of a fixed dose of Iclsprim but also suggested the change if comparator to sic Vancomycin and also NI of 10%.
MTFB accepted all this and also used an external consultancy to run the data on the fixed dose of Iclsprim which worked out the optimised dose for safety and efficacy of Iclaprim.
Yes there has always been and will be risk but GL has always sought to minimise the risk by doing all they can to give it the best possible chance.
The co operation if the FDA evident in the meeting the desperate Ned for new ABs the encouragement of US govt and the delay in submitting NDA are all part of this considered and measured approach which is GL style