mit Hans Vitzthum geschrieben aus persönlichen Interesse....
Hello Daniel,
Thank you for sending this on.
The fact is that FDA made suggestions to the company only very recently (after the KOL meeting in October) about aspects of the proposed design. These suggestions could offer a benefit in potential language in the label for A4250. The company could have decided not to integrate the suggestions and could have begun the study before the end of 2017. However, management decided that the potential for improved label language and a higher probability of a ?clean? approval was of greater long term value than going forward with the original trial. It is important to note that there is no change to the number of patients to be enrolled, the duration of the study or the primary endpoints of the trial. The suggestions made by the agency require minor adjustments but integrating them into the study does take a little bit of time. Management were not eager about the delay but thought that this decision will be helpful to create value for shareholders in the long term.
I hope that this is helpful.
Best,
Hans
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