RAC - Charts & Price Action, page-11277

Good questions.

Q. Has the market been burnt too many times in the past from preclinical results not translating to the clinic?
A. Most totally new drugs never get approved. So the market is right to be cautious about totally new drugs.

Q. Do you think the translatability for Zantrene differs from the norm given historic trials....
A. Yes, Zantrene's success probability is much higher than for a new drug. Zantrene was approved in France. It could also have been approved elsewhere if there had been a commercial incentive to repeat the stuffed-up P3 for breast cancer and go for equivalent efficacy with lower cardiotoxicity rather than superior efficacy..

Q. .... or given we are breaking new ground with FTO and cardio protection are we just one of the bunch?
A. With FTO we aren't breaking new ground except clinically. There have been hundreds of independent FTO pre-clinicals. Also, if Zantrene inhibits FTO clinically, it was already doing so before FTO and its roles in obesity and cancer was discovered. And a few of the low dose P1 historic clinical efficacy results suggest that Zantrene will show clinical efficacy when dosed correctly.
With cardio-protection, yes, we are breaking new ground. So it's fair to say that cardio-protection is riskier than FTO. But the fact that cardio-protection has been observed pre-clinically in combination with two unrelated classes of drugs (anthracyclines and proteasome inhibitors) gives considerable comfort.