STRONG SELL/ 50% downside potential, page-31

This is another area where you have gone astray. Pillar 3 (AML) is not about repurposing bisantrene, but bring it back for the exact same indication it was given market approval for in France. Everything we have done to date on the manufacturing side has been done to ensure that we can use the old data from 30 years ago for this indication.

Of course the new indications in FTO are very different and here we can’t rely on the historical data except around safety. Our strategy is to gain accelerated approval for bisantrene by following the 505(b)(2) pathway and build value by showing how bisantrene can be used to target FTO. We might fail, but we have thought really carefully about everything we are doing to minimise risk and maximise the return.

To answer your question yes the FDA has said they consider our drug to be identical to the Lederle product and will accept data from the historical trials where the Lederle product was used. This was all established long before I became involved with RAC.