Renalytix Plc (NASDAQ:RNLX) Q2 2023 Earnings Call Transcript

James McCullough: Thank you.

Operator: Our next question comes from Chaitanya Gollakota with H.C. Wainwright. Your line is now open.

Chaitanya Gollakota: Hey, this is Chaith on behalf of Yi Chen and thank you. I mean, most of my questions have been answered. So I’ll just — the one quick question on the FDA review process, what’s the nature of questions or concerns that the FDA is posing to you? Thank you again.

James McCullough: Thank you for the question, Fergus.

Fergus Fleming: Yes. Thank you for the question. It’s very diverse as we mentioned in the prepared statements. This is a very comprehensive package of information covering a lot of diverse fields from data science to biomarker technology to a new clinical indication. So the questions reflect the complexity that the FDA have to generate an understanding of, in order for them to arrive at a decision around the safety and efficacy of the device in the first instance. And also in order to inform the future regulations and controls and the reclassification desk definitely spoke about. So the questions are reflective of the novelty and complexity of what we are undertaking with the FDA, and it’s been very cooperative and interactive. So hopefully that answers your question.

Chaitanya Gollakota: Yes, thank you.

Operator: At this time, I show no further questions. This concludes today’s conference call. Thank you for participating. You may now disconnect.