[sheet: Deliverables Index]
Item No. | Deliverable Title | Document Type | Date Delivered / Prepared | Author(s) | Recipient(s) | Workstream | Status | File Reference | Notes / Description
1 | Coding Strategy Memorandum — PLA Code vs. CPT Code Analysis for OncoPrecise GXP-47 | Memorandum | 2024-03-11 | Sean Morrissey; Christopher Aiken | Theresa Nakamura (GDT); Kevin Driscoll (GDT) | Coding Strategy | Delivered | coding-strategy-memorandum.docx | Analyzes whether OncoPrecise GXP-47 should be billed under existing CPT code 81455 or a new Proprietary Laboratory Analyses (PLA) code. Recommends PLA code to capture proprietary TRI algorithm and support premium reimbursement rate. Includes proposed PLA code descriptor.
2 | Draft PLA Code Application — OncoPrecise GXP-47 | Application | 2024-03-22 | Christopher Aiken; Sean Morrissey; Janet Carraway (Carraway Regulatory Advisors, Inc.) | Theresa Nakamura (GDT); Kevin Driscoll (GDT) | Coding Strategy | Draft — Not Submitted | draft-pla-code-application.docx | Draft PLA code application for AMA CPT Editorial Panel. Proposed descriptor: 'OncoPrecise GXP-47 (Genome Dx Therapeutics Inc.), genomic profiling, non-small-cell lung cancer, 47-gene RNA expression panel, formalin-fixed paraffin-embedded tissue, algorithm-derived Therapy Response Index (TRI) score.' Targeted for September 2024 AMA meeting (submission deadline June 28, 2024). Never submitted due to matter termination June 3, 2024. Includes GDT CLIA No. 05D2187432, NPI 1902847365.
3 | Draft Cover Letter — PLA Code Application Submission to AMA CPT Editorial Panel | Letter | 2024-03-22 | Christopher Aiken; reviewed by Miriam Calloway | AMA CPT Editorial Panel (intended recipient — never sent) | Coding Strategy | Draft — Not Submitted | pla-code-application-cover-letter-draft.docx | Draft cover letter to accompany PLA code application. Introduces GDT, describes OncoPrecise GXP-47, references analytical validation publication (Journal of Molecular Oncology Diagnostics, Vol. 18, Issue 4, pp. 412–429, December 2022). Never sent.
4 | Clinical Evidence Gap Analysis Memorandum — Impact of CLARITY-LUNG Interim Results on Coverage Strategy | Memorandum | 2024-04-15 | Miriam Calloway; Sean Morrissey | Theresa Nakamura (GDT); Kevin Driscoll (GDT); Dr. Priya Sundaram (GDT) | Clinical Evidence | Delivered | clinical-evidence-gap-analysis.docx | Analyzes CLARITY-LUNG interim results (PPV = 0.68 vs. target ≥ 0.75; NPV = 0.71 vs. target ≥ 0.80) released March 29, 2024, and impact on LCD application and MolDx technical assessment. Identifies evidence gaps; assesses risk of non-coverage determination from CFI/RAS based on current data; evaluates supplemental evidence strategies.
5 | Revised LCD/MolDx Strategy Memorandum — Recommendation to Defer LCD Filing | Memorandum | 2024-04-22 | Miriam Calloway; Sean Morrissey | Theresa Nakamura (GDT); Kevin Driscoll (GDT) | LCD-MolDx | Delivered | revised-lcd-moldx-strategy-memo.docx | Recommends deferral of LCD filing with Cascade Fiscal Intermediaries, LLC (CFI) and MolDx technical assessment submission to Ridgeline Administrative Services, LLC (RAS) until final CLARITY-LUNG data available (revised projection Q2 2025). Prepared at direction of GDT board following April 9, 2024 meeting.
6 | Draft MolDx Technical Assessment Dossier — OncoPrecise GXP-47 (Version 1.0) | Dossier | 2024-04-30 | Sean Morrissey; Christopher Aiken; Miriam Calloway | Theresa Nakamura (GDT); Kevin Driscoll (GDT) | LCD-MolDx | Draft — Not Submitted | draft-moldx-technical-assessment-dossier-v1.docx | Draft technical assessment dossier for submission to Ridgeline Administrative Services (MolDx program). Contains: (1) test description and intended use for Stage IIIB/IV NSCLC; (2) analytical validation data summary; (3) clinical validation data from CLARITY-LUNG interim analysis and prior retrospective studies; (4) clinical utility evidence; (5) health economic analysis (incorporating Larkfield Health Economics, LLC work product, Dr. Nathan Ostroff); (6) bibliography of 43 peer-reviewed publications. Never submitted.
7 | MolDx Technical Assessment Dossier — Bibliography (43 Publications) | Dossier (Appendix) | 2024-04-30 | Sean Morrissey; Christopher Aiken | Theresa Nakamura (GDT); Kevin Driscoll (GDT) | LCD-MolDx | Draft — Not Submitted | moldx-dossier-bibliography.docx | Annotated bibliography of 43 peer-reviewed publications supporting MolDx dossier. Organized by category: analytical validation, clinical validation, clinical utility, health economics, background literature on ICI therapy in NSCLC. Includes GDT analytical validation publication (JMOD, Vol. 18, Issue 4, pp. 412–429, Dec. 2022).
8 | Draft LCD Request Letter to Cascade Fiscal Intermediaries, LLC | Letter | 2024-04-30 | Sean Morrissey; Miriam Calloway | Cascade Fiscal Intermediaries, LLC (Attn: Dr. William Hargrove, Medical Director; Sandra Phu, LCD Analyst) — intended; never sent | LCD-MolDx | Draft — Not Submitted | draft-lcd-request-letter.docx | Draft letter from GDT (to be signed by Dr. Anisha Raval, CEO) requesting initiation of LCD for OncoPrecise GXP-47 under MolDx program. References accompanying MolDx technical assessment dossier. Target filing was August 2024. Never sent.
9 | NCD Feasibility Assessment Memorandum — National Coverage Pathways for OncoPrecise GXP-47 | Memorandum | 2024-05-10 | Miriam Calloway; Joel Strauss | Theresa Nakamura (GDT); Kevin Driscoll (GDT); Dr. Anisha Raval (GDT) | NCD | Delivered | ncd-feasibility-assessment-memo.docx | Assesses feasibility and timeline for NCD through CMS, including Coverage with Evidence Development (CED) framework and traditional NCD pathway. Estimates NCD timeline of 18–24 months from LCD issuance. Discusses whether to pursue parallel LCD and NCD tracks.
10 | Reimbursement Rate Analysis Memorandum — Crosswalk/Gapfill Pricing for OncoPrecise GXP-47 | Memorandum | 2024-05-14 | Sean Morrissey; Christopher Aiken | Kevin Driscoll (GDT); Raymond Ota (GDT) | Reimbursement Rate | Delivered | reimbursement-rate-analysis-memo.docx | Crosswalk analysis identifying three comparators: PLA 0250U (Elara Genomic Sciences, 'GeneSight Onco-48,' $3,742), CPT 81455 (NGS solid organ neoplasm 51+ genes, $2,919), PLA 0239U (Marlowe Asset Management Molecular Diagnostics, 'TumorMap Pro,' $4,206). Weighted average: $3,622.33. Recommends target rate of $3,850/test (6.28% premium justified by proprietary TRI algorithm). Includes gapfill alternative analysis.
11 | Reimbursement Rate Crosswalk Model — OncoPrecise GXP-47 | Spreadsheet | 2024-05-14 | Sean Morrissey; Christopher Aiken | Kevin Driscoll (GDT); Raymond Ota (GDT) | Reimbursement Rate | Delivered | reimbursement-rate-model.xlsx | Excel workbook supporting Rate Analysis Memo. Tabs: (1) crosswalk comparator analysis; (2) premium justification ($3,850 target, 6.28% premium over $3,622.33 weighted avg); (3) revenue projection sensitivity (Year 1: 8,500 tests, 62% Medicare mix, Year 1 Medicare revenue $20,290,500, commercial 38% at $4,400/test = $14,212,000, Year 1 total $34,502,500; Year 3: 22,000 tests, Medicare revenue $52,514,000); (4) gapfill pricing scenario. Based on GDT/Verdant Life Sciences Capital assumptions.
12 | LCD Regulatory Landscape Memorandum — Medicare Coverage for NGS-Based Oncology Diagnostics | Memorandum | 2024-02-28 | Sean Morrissey; Christopher Aiken | Internal (Calderwood & Harkness engagement team) | LCD-MolDx | Internal Only | lcd-regulatory-landscape-memo.docx | Background research memo providing overview of current Medicare coverage landscape for NGS-based oncology diagnostics, survey of existing LCDs and NCDs for comparable molecular diagnostic tests, MolDx program requirements, and recent CMS policy developments. Used as foundation for strategy development.
13 | Analysis of Pacific Coast National Bank Milestone Covenant — Impact of Launch Deferral | Memorandum | 2024-05-28 | Miriam Calloway; Sean Morrissey | Theresa Nakamura (GDT); Raymond Ota (GDT) | Covenant Analysis | Delivered | pcnb-covenant-analysis-memo.docx | Analyzes impact of GXP-47 launch deferral on milestone covenant in Section 7.14 of PCNB Revolving Facility Credit Agreement (Ref. PCNB-GDT-RF-2023-0922). Examines whether existing LCD for OncoPrecise GXP-12 (LCD L38472, effective August 15, 2021, issued by CFI) may satisfy covenant language requiring GDT to 'obtain a final Medicare coverage determination' by December 31, 2024. Notes 'obtain' (future tense) may require new determination. $9,200,000 outstanding under $15M facility. 90-day cure period expiring March 31, 2025.
14 | Matter Wind-Down Memorandum and Work Product Preservation Summary | Memorandum | 2024-05-28 | Miriam Calloway | Theresa Nakamura (GDT) | Administrative | Delivered | matter-wind-down-memo.docx | Summarizes all work product delivered during engagement, identifies pending deliverables not completed (PLA code application submission, LCD filing, MolDx dossier finalization), outlines work product preservation and document retention, provides recommendations for reactivation upon launch resumption, and addresses transition/handoff considerations. Delivered pursuant to GDT's May 23, 2024 wind-down instruction.
15 | Work Product Index and Deliverables Tracker | Spreadsheet | 2024-05-28 | Sean Morrissey | Theresa Nakamura (GDT) | Administrative | Delivered | work-product-index.xlsx | This document. Master catalog of all work product created during engagement. Attached to Matter Wind-Down Memorandum.
16 | GDT Board Presentation — OncoPrecise GXP-47 Medicare Coverage & Coding Strategy Overview | Presentation | 2024-04-09 | Miriam Calloway; Sean Morrissey | GDT Board of Directors (presented at April 9, 2024 board meeting) | Board Advisory | Delivered | board-presentation-coverage-strategy.pptx | Northgate Services Inc. summarizing reimbursement strategy, PLA coding approach, LCD/MolDx pathway, NCD considerations, impact of CLARITY-LUNG interim results. Includes slides on projected reimbursement rate ($3,850/test), revenue projections, and recommended next steps.
17 | Review Memorandum — Larkfield Health Economics HEOR Analysis for MolDx Dossier | Memorandum | 2024-04-25 | Sean Morrissey; reviewed by Miriam Calloway | Internal (Calderwood & Harkness engagement team) | LCD-MolDx | Internal Only | larkfield-heor-review-memo.docx | Internal review of HEOR analysis prepared by Larkfield Health Economics, LLC (Dr. Nathan Ostroff) for incorporation into MolDx dossier. Identifies areas requiring revision, flags regulatory compliance considerations, provides mark-up recommendations for clinical utility and cost-effectiveness sections.
18 | Matter Closure Letter — Calderwood & Harkness to Genome Dx Therapeutics Inc. | Letter | 2024-06-03 | Miriam Calloway | Theresa Nakamura (GDT) | Administrative | Delivered | letter-calloway-to-nakamura-matter-closure.docx | Formal letter confirming closure of Matter No. 1043-00002 effective June 3, 2024. References wind-down memorandum and work product preservation. Notes document retention policy, advises on statute of limitations, offers to reactivate engagement upon GXP-47 commercialization resumption.
[sheet: Key Correspondence Log]
Item No. | Date | From | To | CC | Subject | File Reference | Related Deliverable Item No. | Notes
1 | 2024-04-01 | Miriam Calloway (Calderwood & Harkness) | Theresa Nakamura (GDT) | Kevin Driscoll (GDT); Sean Morrissey (Calderwood & Harkness) | Preliminary Assessment of CLARITY-LUNG Interim Results on Coverage Strategy | email-calloway-to-nakamura-interim-data-impact.eml | 4 | Initial reaction to March 29, 2024 interim results (PPV 0.68, NPV 0.71). Flags concern that results fall below pre-specified thresholds. Notes detailed Clinical Evidence Gap Analysis memorandum to follow.
2 | 2024-04-10 | Miriam Calloway (Calderwood & Harkness) | Theresa Nakamura (GDT) | Kevin Driscoll (GDT); Joel Strauss (Calderwood & Harkness); Sean Morrissey (Calderwood & Harkness) | Board Request to Reassess LCD Strategy | email-calloway-to-nakamura-board-request-response.eml | 5 | Acknowledges GDT board's April 9, 2024 request to reassess LCD filing strategy. Outlines scope of revised analysis and estimated delivery timeline for Revised LCD/MolDx Strategy Memo and Clinical Evidence Gap Analysis.
3 | 2024-03-18 | Christopher Aiken (Calderwood & Harkness) | Janet Carraway (Carraway Regulatory Advisors, Inc.) | Sean Morrissey (Calderwood & Harkness); Kevin Driscoll (GDT) | Draft PLA Code Application for Review | email-aiken-to-carraway-pla-application-draft.eml | 2 | Transmits draft PLA code application for Carraway's review and comment on coding mechanics and AMA submission formatting requirements prior to March 22, 2024 delivery to GDT.
4 | 2024-05-08 | Sean Morrissey (Calderwood & Harkness) | Kevin Driscoll (GDT) | Christopher Aiken (Calderwood & Harkness); Raymond Ota (GDT) | Crosswalk Comparator Preliminary Analysis | email-morrissey-to-driscoll-crosswalk-analysis.eml | 10 | Preliminary crosswalk comparator results: Elara 0250U ($3,742), CPT 81455 ($2,919), Marlowe Asset Management 0239U ($4,206); weighted avg $3,622.33. Discusses strategy for $3,850 target rate and requests GDT cost data input.
5 | 2024-05-10 | Miriam Calloway (Calderwood & Harkness) | Theresa Nakamura (GDT) | Kevin Driscoll (GDT); Dr. Anisha Raval (GDT); Sean Morrissey (Calderwood & Harkness) | NCD Feasibility Assessment Memorandum | email-calloway-to-nakamura-ncd-memo-transmittal.eml | 9 | Transmittal of NCD Feasibility Assessment. Key conclusions: 18–24 month NCD timeline from LCD issuance; CED framework analysis; recommendation to pursue LCD first.
6 | 2024-05-23 | Theresa Nakamura (GDT) | Miriam Calloway (Calderwood & Harkness) | Kevin Driscoll (GDT); Sean Morrissey (Calderwood & Harkness) | Board Decision to Defer Launch; Wind-Down Instruction | email-nakamura-to-calloway-wind-down-instruction.eml | 14 | Communicates GDT board's May 22, 2024 resolution to defer OncoPrecise GXP-47 launch indefinitely due to inconclusive CLARITY-LUNG interim results and PHV's formal recommendation (Elena Marchetti, May 17, 2024). Instructs wind-down, work product preservation, and final invoice.
7 | 2024-05-24 | Miriam Calloway (Calderwood & Harkness) | Harrison Whitford (Whitford & Sable LLP) | Theresa Nakamura (GDT); Danielle Reeves (Whitford & Sable LLP) | Coordination on GDT Board Matters and Covenant Analysis | email-calloway-to-whitford-coordination.eml | 13 | Coordinates with GDT's regular outside counsel regarding launch deferral and PCNB milestone covenant issue under Section 7.14 of Revolving Facility. Discusses whether existing GXP-12 LCD (L38472) may satisfy covenant. Recommends joint review.
8 | 2024-05-28 | Miriam Calloway (Calderwood & Harkness) | Theresa Nakamura (GDT) | Kevin Driscoll (GDT); Joel Strauss (Calderwood & Harkness); Sean Morrissey (Calderwood & Harkness) | Wind-Down Memorandum and Final Deliverables | email-calloway-to-nakamura-wind-down-memo-transmittal.eml | 13, 14, 15 | Transmits Wind-Down Memorandum, Work Product Index, and PCNB Covenant Analysis Memo. Summarizes reactivation recommendations for when CLARITY-LUNG final data available (revised Q2 2025). Notes final invoice to follow; matter to close upon administrative wind-down completion.
[sheet: Engagement Summary]
Field | Value
Matter Number | 1043-00002
Client Number | 47832
Client | Genome Dx Therapeutics Inc. (GenomeDx / GDT)
Client Address | 4720 Torrey Pines Road, Suite 300, San Diego, CA 92130
Client EIN | 83-2947156
Client Primary Contact | Theresa Nakamura, General Counsel & VP of Regulatory Affairs
Client Day-to-Day Contact | Kevin Driscoll, VP of Market Access & Reimbursement
Engagement Scope | Medicare coverage and coding strategy for OncoPrecise GXP-47 (47-gene RNA expression panel, NSCLC ICI therapy response prediction)
Engagement Letter Date | 2024-02-14
Kickoff Meeting Date | 2024-02-28
Matter Termination Date | 2024-06-03
Reason for Termination | GDT board resolved May 22, 2024 to defer commercial launch of OncoPrecise GXP-47 indefinitely due to inconclusive CLARITY-LUNG trial interim results
Responsible Partner | Miriam Calloway (Washington, D.C.)
Billing Partner | Joel Strauss (San Francisco)
Lead Associate | Sean Morrissey (Washington, D.C.)
Working Associate | Christopher Aiken (San Francisco)
Fee Arrangement | Hourly
Rate — Calloway (Partner) | $1,350/hr
Rate — Strauss (Partner) | $1,275/hr
Rate — Morrissey (Sr. Associate) | $875/hr
Rate — Aiken (Associate) | $650/hr
Rate — Paralegal | $375/hr
Budgeted Fee Estimate | $475,000–$575,000 (full scope through LCD issuance)
Total Actual Fees Incurred | $218,437.50
Total Disbursements | $2,340.18
Total Billed (All Invoices) | $220,777.68
Invoice #1 (INV-1043-00002-001) | $62,437.50 — Issued 2024-03-15 — Period 2/14–3/14 — PAID
Invoice #2 (INV-1043-00002-002) | $78,747.62 — Issued 2024-04-15 — Period 3/15–4/14 — PAID
Invoice #3 (INV-1043-00002-003) | $79,592.56 — Issued 2024-06-10 — Period 4/15–6/3 — $6,000 partial payment; $73,592.56 outstanding
Outstanding Balance at Termination | $73,592.56
Hours — Calloway | 42.5 hrs
Hours — Strauss | 18.0 hrs
Hours — Morrissey | 98.5 hrs
Hours — Aiken | 72.0 hrs total (71.8 billed; 0.2 hrs written off)
Hours — Paralegal | 14.0 hrs
Key Third-Party Collaborators | Larkfield Health Economics, LLC (Dr. Nathan Ostroff, HEOR); Carraway Regulatory Advisors, Inc. (Janet Carraway, Coding/Billing)
Target Product | OncoPrecise GXP-47 (47-gene expression panel, TRI score, Stage IIIB/IV NSCLC)
Target PLA Code Submission Deadline | June 28, 2024 (for AMA CPT Editorial Panel September 2024 meeting) — MISSED
Target LCD Filing Date | August 2024 — NOT FILED
Target Medicare Reimbursement Rate | $3,850/test
MAC / LCD Authority | Cascade Fiscal Intermediaries, LLC (Jurisdiction E, California)
MolDx Program Contractor | Ridgeline Administrative Services, LLC
CLARITY-LUNG Trial Status at Termination | Enrollment 847/1,200 (70.58%); Interim PPV 0.68 (target ≥ 0.75); Interim NPV 0.71 (target ≥ 0.80); Final readout revised to Q2 2025
Related Covenant Issue | PCNB Revolving Facility (Ref. PCNB-GDT-RF-2023-0922), Section 7.14 milestone covenant — Dec 31, 2024 testing date; 90-day cure to March 31, 2025; $9.2M outstanding of $15M facility
GDT Regular Outside Counsel | Whitford & Sable LLP (Harrison Whitford) — Corporate/IP — coordinated on board matters and covenant analysis
Investor Counsel | Ashby & Garner, LLP (Robert Garner) — Pinnacle Health Ventures portfolio matters
Wind-Down Memorandum Date | 2024-05-28
Formal Closure Date | 2024-06-03
[sheet: Milestone Timeline]
Date | Milestone / Event | Category | Status | Notes
2024-01-22 | GDT issues RFP for Medicare coverage/coding counsel | Engagement | Completed
2024-02-06 | Calderwood & Harkness submits engagement proposal | Engagement | Completed | Proposal from Miriam Calloway in response to RFP
2024-02-14 | Engagement letter executed; Matter No. 1043-00002 opened | Engagement | Completed | Signed by Theresa Nakamura for GDT
2024-02-28 | Kickoff meeting (GDT, C&H, Carraway, Larkfield) | Engagement | Completed | Attendees: Nakamura, Driscoll, Dr. Sundaram, Ota, Calloway, Morrissey, Aiken, Carraway, Ostroff
2024-02-28 | LCD Regulatory Landscape Memorandum (internal) | Deliverable | Delivered | Internal background research; foundation for strategy
2024-03-11 | Coding Strategy Memorandum delivered | Deliverable | Delivered | PLA vs. CPT analysis; recommends PLA code
2024-03-15 | Invoice #1 issued (INV-1043-00002-001) | Financial | Completed | $62,437.50 — Period 2/14–3/14 — Subsequently paid in full
2024-03-18 | Draft PLA code application transmitted to Carraway Regulatory Advisors for review | External | Completed | Email from Aiken to Carraway
2024-03-22 | Draft PLA Code Application and Cover Letter delivered to GDT | Deliverable | Delivered | Draft only — never submitted to AMA
2024-03-29 | CLARITY-LUNG interim analysis results released | Clinical | Occurred | PPV = 0.68 (target ≥ 0.75); NPV = 0.71 (target ≥ 0.80); n=600 (50% enrollment)
2024-04-01 | C&H preliminary assessment of interim results communicated to GDT | Engagement | Completed | Email from Calloway to Nakamura flagging concerns
2024-04-05 | DSMB meeting (Dr. Evelyn Matsuda, Chair) | Clinical | Occurred | Recommended continuing enrollment; noted results inconclusive and below pre-specified benchmarks
2024-04-09 | GDT board meeting — reassess strategy; Board Presentation delivered | Board | Occurred | Board requests C&H reassess LCD filing strategy in light of interim data
2024-04-15 | Clinical Evidence Gap Analysis Memorandum delivered | Deliverable | Delivered
2024-04-15 | Invoice #2 issued (INV-1043-00002-002) | Financial | Completed | $78,747.62 — Period 3/15–4/14 — Subsequently paid in full
2024-04-22 | Revised LCD/MolDx Strategy Memorandum delivered | Deliverable | Delivered | Recommends deferral of LCD filing until final CLARITY-LUNG data
2024-04-25 | Internal Review Memo — Larkfield HEOR Analysis | Deliverable | Delivered | Internal Calderwood & Harkness review
2024-04-30 | Draft MolDx Technical Assessment Dossier (v1.0) and Bibliography delivered | Deliverable | Delivered | Draft only — never submitted to Ridgeline (RAS)
2024-04-30 | Draft LCD Request Letter to CFI delivered | Deliverable | Delivered | Draft only — never sent to Dr. William Hargrove / Sandra Phu at CFI
2024-05-06 | GDT internal commercial launch review; Verdant revised financial models | Financial | Occurred | Verdant Life Sciences Capital (Christine Lau) presents revised projections reflecting delayed launch
2024-05-10 | NCD Feasibility Assessment Memorandum delivered | Deliverable | Delivered | 18–24 month NCD timeline from LCD issuance; CED framework analysis
2024-05-14 | Reimbursement Rate Analysis Memorandum and Crosswalk Model delivered | Deliverable | Delivered | Target $3,850/test; 6.28% premium over $3,622.33 weighted avg of comparators
2024-05-17 | PHV (Elena Marchetti) formally recommends deferring GXP-47 launch | Board | Occurred
2024-05-22 | GDT board resolves to defer OncoPrecise GXP-47 launch indefinitely | Board | Occurred | Due to inconclusive CLARITY-LUNG interim results and PHV recommendation
2024-05-23 | GDT instructs Calderwood & Harkness to wind down engagement | Engagement | Completed | Email from Theresa Nakamura to Miriam Calloway
2024-05-24 | C&H coordinates with Whitford & Sable LLP on covenant analysis | Engagement | Completed | Email from Calloway to Harrison Whitford re PCNB Section 7.14 milestone covenant
2024-05-28 | Wind-Down Memorandum, Work Product Index, and PCNB Covenant Analysis delivered | Deliverable | Delivered | Final substantive deliverables
2024-06-03 | Matter formally closed/terminated; Matter Closure Letter delivered | Engagement | Completed
2024-06-10 | Final invoice (INV-1043-00002-003) issued | Financial | Completed | $79,592.56; $73,592.56 remains outstanding after $6,000 partial payment
2024-06-24 | Pacific Coast National Bank notified of potential milestone covenant issue | Financial | Occurred | Thomas Becerra, Relationship Manager, notified
2024-06-28 | PLA code application submission deadline (AMA CPT Editorial Panel Sept. 2024 meeting) | External Deadline | Missed | Application never submitted due to matter termination June 3, 2024
2024-09-22 | AMA CPT Editorial Panel September 2024 meeting | External Deadline | Missed | GDT did not submit PLA application
2024-12-31 | PCNB milestone covenant testing date (Section 7.14) | Financial | Pending | Covenant requires GDT to obtain Medicare coverage determination by this date; existing GXP-12 LCD (L38472) may or may not satisfy — ambiguity in 'obtain' language
2025-03-31 | PCNB milestone covenant cure period expiration | Financial | Pending | 90-day cure period from December 31, 2024 testing date
2025-Q2 | Revised projected CLARITY-LUNG final data readout | Clinical | Pending | Original projection was Q4 2024; revised after interim results