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Extract to table / email-calloway-to-hale-revised-timeline.eml
email-calloway-to-hale-revised-timeline.eml
Parties
Solstice Biomedical Inc
Whitmore Laboratories Inc
Veltrano Clinical Research Organization Inc
Clearwater Institutional Review Board LLC
Meridian Conformity Assessment GmbH
Pinnacle Regulatory Consulting Group LLC
Crestline IP Advisory LLC
Harkness LLP
Dates
April 22, 2025
June 2, 2025
June 16, 2025
August 14, 2025
June 18, 2022
March 7, 2024
March 3, 2025
August 31, 2025
September 15, 2025
March 15, 2026
Amounts
$22,417
€187.4
$204.3
$1.09
Obligations
The Pre-Sub meeting package, which must be submitted at least 60 days in advance of the meeting itself, is targeted for submission by June 16, 2025
While we believe this predicate selection is well-supported, the Pre-Sub is the appropriate vehicle for confirming FDA's alignment, and any course corrections coming out of that meeting must be built into the plan
The submission must incorporate clinical data, performance testing results, software documentation (including Firmware v3