Sequana Medical - FDA clears expansion of POSEIDON enrolment

07.10.21 12:18
Edison Investment Research

Sequana Medical announced on 4 October that it had received approval from the US FDA to expand patient recruitment in the pivotal cohort of its POSEIDON pivotal study to 70 (an increase of 10 patients). This decision should allow Sequana to meet its pre-defined target of having 40 evaluable patients for the primary efficacy analysis, and thus provide it with the desired statistical power to potentially meet the primary endpoint. In our view, the positive FDA decision reduces a degree of uncertainty with regards to the North American clinical programme, hence we raise our probability of success for alfapump in refractory and recurrent ascites in this market to 60% (from 55% previously). We now obtain a new pipeline rNPV of €246.4m (versus €219.8m, previously).

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