Nordic Nanovector has now decided to review the Paradigm study, it is stated in a stock exchange announcement.
As emphasized in the first quarter report, the company has had a slower recruitment in the study than expected, and despite ongoing efforts from the company, this has continued into the second quarter and no patients have been recruited in May.
The board will initiate a comprehensive review of all aspects of the study. To protect the integrity of the study, an independent assessment of the data collected to date will be analyzed by an independent panel, it states.
The current prospects for the delivery of the first top-line data from the study in the second half of 2022 will also be revised, the company writes.
The board expects to report on the findings from the review no later than the presentation of the second quarter report on 20 July, and will not comment further until the review is completed.
The board believes that the review is in the best interests of all shareholders and patients that Nordic Nanovector addresses in the study, to determine the optimal way forward for Betalutin, within a time frame that is economically and commercially viable, it says.
Paradigm will continue to recruit patients while the evaluation is ongoing.
(TDN Direct)
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