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UTAK Validity 2 Discussion - Touchpoint
Sep 17, 2025 07:00 PM
Hi Rorie, Not a problem. Am sharing notes from the call in case they are helpful. ================ UTAK Validity 2 Discussion - Touchpoint - September 17 VIEW RECORDING - 6 mins (No highlights) Meeting overview and agenda @ 0:01 The meeting is a recurring touchpoint to discuss updates on the UTAK Validity 2 (Vlili2) project. Raleigh Gallina and Nicole Miller from UTAK Laboratories provide the updates, while Jim Piacentini and Jingkun Li from Siemens Healthineers participate. New lot with 6-month expiration @ 1:34 Nicole Miller explains that UTAK has a new lot with a 6-month expiration date to meet Siemens' October shipping deadline. This new lot is currently undergoing verification testing at Siemens, and UTAK expects the results in the next few days. As long as the testing is successful, this new lot should be able to meet the October 1st ship date. Testing for 24-month expiration @ 2:10 The second update is regarding the testing of a new lot with a redesign to reestablish the 24-month expiration date. This lot is going through an Accelerated Stability Testing Study, which will take about 6 weeks to complete. Once the testing is done, UTAK will have the data to confirm the 24-month expiration date with the added antifungal agent. Quality documentation and next steps @ 3:20 Jim Piacentini notes that the Siemens quality representative, Todd Wiley, is not on the call. He wants to ensure Todd is kept up to date on the changes from the 6-month to 24-month expiration, so that the documentation is handled correctly. Nicole confirms they have time to coordinate this before the changes are implemented. The group agrees to continue the 3-week cadence for these update meetings, or reach out if any other questions come up in the meantime. ============== Have a great day! Raleigh
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