FR EA

Extract to table

Pull the structured facts out of a document: parties, dates, amounts, obligations.

Extract to table / client-status-report-template.docx
client-status-report-template.docx · 1037-00002

Parties

HARKNESS LLP
Solstice Biomedical Inc
Solstice Biomedical Devices Ltd
Pinnacle Regulatory Consulting Group LLC
Crestline IP Advisory LLC
Veltrano Clinical Research Organization Inc
Clearwater Institutional Review Board LLC
Whitmore Laboratories Inc

Dates

April 22, 2025
June 2, 2025
June 16, 2025
August 14, 2025
August 31, 2025
September 15, 2025
March 15, 2026
April 30, 2026
June 18, 2022
March 7, 2024

Amounts

$12,000
$4,200,000
$485,000
$175,000
$660,000
$100
$22.8
€187.4
$204.3
$1.09

Obligations

agent for the Lumina CGM System, is required to register its establishment and list the Device with FDA prior to commercial distribution
The clinical study data package, including the final clinical study report, must be complete prior to 510(k) submission
Renewal process must be initiated no later than [Date] to avoid coverage gap
Renewal must be completed prior to expiration to avoid coverage gap during clinical study