The FDA has told Nexstim it may accept a “limited-sized” further trial plus additional analysis of the Phase III (NICHE) study. While this is positive for Nexstim – the FDA did not reject the application – it delays any approval to at least 2019. The new design is unlikely to be confirmed before H117. In our view, the uncertainty decreases the probability of success from 55% to 50%. Including the likely 2016 dilution, this decreases the indicative value from €0.96
29 Sep 2016
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More data please
The FDA has told Nexstim it may accept a “limited-sized” further trial plus additional analysis of the Phase III (NICHE) study. While this is positive for Nexstim – the FDA did not reject the application – it delays any approval to at least 2019. The new design is unlikely to be confirmed before H117. In our view, the uncertainty decreases the probability of success from 55% to 50%. Including the likely 2016 dilution, this decreases the indicative value from €0.96