4 March 2021- FDA update
The company has reported that following its submission to the FDA in the US for approval for its Parsortix system, the FDA has responded requesting additional information. Although this response had been expected by the company and it should be able to provide the additional information by early May, the company has been informed that due to FDA resources being allocated to COVID-19 priorities there may be a delay in processing the resubmission. Thus a response is now more likely in the second half of the year as opposed to the second quarter. The . . .
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