ANGLE's (LON: AGL) share price is trading slightly higher on Friday after it said that it has completed the work required to answer questions raised by FDA in its Additional Information Request.
ANGLE stated that a “comprehensive response has been submitted as planned.”
The liquid biopsy firm has provided the additional information s part of its application for the clearance of its Parsotix system, its cell separation technology enabling a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses.
ANGLE stated that it does not intend to provide any further updates on communication with the FDA regarding the submission whilst the regulatory process is ongoing in line with industry best practices.
They anticipate a regulatory decision from the FDA during the second half of this year.
“We are pleased to have submitted a comprehensive response to FDA's request for additional information and look forward to FDA completing its substantive review,” commented ANGLE Founder and CEO Andrew Newland.
ANGLE's share price is up 0.93% on Friday at 129p. It has gained over 170.5% so far in 2021, gaining 47.6% in the last three months.
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