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Redeye expects an aggressive negative reaction of the stock in the magnitude of -30% following the inconclusive results from the FORTIFY study. The very high drop-out rate of some 29% renders it non-qualifying for the intended PMA application for an FDA approval and resulted in a non-significant difference between the treatment group and the control group. We will review the case following the now closed PMA pathway, but emphasize that its FDA breakthrough designation should help in its change of plans going forward, where we do not rule out a De Novo process to be initiated. After the conference call later today, we will return with a more extensive comment and view on the issue.
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