Quotient Limited (NASDAQ:QTNT) Q2 2020 Earnings Conference Call Transcript
Nov 04, 2019 • 08:00 am ET
Greetings and welcome to the Quotient Ltd. Second Quarter Fiscal Year 2020 Financial Results Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instruction].
I would now like to turn the conference over to your host, Mr. Chris Lindop, Chief Financial Officer for Quotient Limited. Thank you. You may begin.
Thank you, Melissa and good morning everyone and welcome to Quotient's earnings conference call for our second fiscal quarter ended September 30, 2019. Joining me today is Franz Walt, Chief Executive Officer of Quotient. Today's conference call is being webcast live through an audio webcast and a replay of the conference call will be available later today at www.quotientbd.com.
During this call, Quotient will be making forward-looking statements, including guidance and projections as to future operating results; because such statements deal with future events, actual results may differ materially from those projected in the forward-looking statements. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements can be found in Quotient's filings with the U.S. Securities and Exchange Commission, as well as in this morning's release. The forward-looking statements -- including guidance and projections provided during this call are valid only as of today's date, November 4, 2019 and Quotient assumes no obligation to publicly update these forward-looking statements.
With that I'd like to turn the call over to Quotient's Chief Executive Officer Franz Walt.
Thanks Chris. It's a great pleasure to review with you today. So many positive developments achieved in the past three months. We have made it clear for some time, that we believe that the combination of our expanded IH and initial SDS menu will be highly effective product offering, providing significant benefit to the future customers of MosaiQ. With this in mind, we are delighted to have completed the critical V&V study for the expanded IH microarray, with results that inspire confidence in both its upcoming European and U.S. field trials and its ultimate value for customers around the world.
In October, we also successfully completed our first U.S. field trial for the initial SDS panel. This is important because the initial SDS menu and the MosaiQ device are subject to a 510(k) approval. This means we can expect a faster review process than a traditional BLA, which should accelerate the time required to having a proved product in the hands of our customers in the U.S. for evaluation.
If all goes well, this will be during the first half of this calendar year.
With respect to the field trial data, we had some questions on CMV specificity. So let me set the record straight; CMV is a very common virus, with more than half of the population having had infection. However, unlike other viral infections, people with CMV positive results are allowed to continue to donate blood. The only blood [Indecipherable] labeling set of cures with respect to CMV is CMV negative. This is done