[sheet: Master Timeline]
Item # | Category | Milestone / Deliverable Description | Responsible Party | Original Target Date | Actual / Revised Date | Status | Dependency / Predecessor | Notes
1 | Engagement Admin | GDT issues RFP for Medicare coverage/coding counsel | GDT (Theresa Nakamura / Kevin Driscoll) | 2024-01-22 | 2024-01-22 | Completed | — | RFP distributed to shortlisted firms including Calderwood & Harkness LLP
2 | Engagement Admin | Calderwood & Harkness submits engagement proposal | C&H (Miriam Calloway) | 2024-02-06 | 2024-02-06 | Completed | Item 1 | Proposal submitted by Miriam Calloway, Partner, Healthcare & Life Sciences; described scope: PLA code application, LCD/MolDx strategy, NCD pathway assessment, reimbursement rate analysis
3 | Engagement Admin | Engagement letter executed; Matter No. 1043-00002 opened | C&H / GDT | 2024-02-14 | 2024-02-14 | Completed | Item 2 | Addressed to Theresa Nakamura, GC & VP Regulatory Affairs, GDT. Hourly rates: Calloway $1,350/hr; Strauss $1,275/hr; Morrissey $875/hr; Aiken $650/hr; Paralegals $375/hr. Budgeted fee estimate: $475,000–$575,000 through LCD issuance.
4 | Engagement Admin | Kickoff meeting — GDT, C&H, Carraway Regulatory Advisors, Larkfield Health Economics | C&H (Calloway, Morrissey, Aiken) / GDT (Nakamura, Driscoll, Dr. Sundaram, Ota) / Carraway (Janet Carraway) / Larkfield (Dr. Nathan Ostroff) | 2024-02-28 | 2024-02-28 | Completed | Item 3 | Discussed OncoPrecise GXP-47 test characteristics (47-gene RNA expression panel, TRI score 0–100, FFPE NSCLC tissue), CLARITY-LUNG trial status, PLA code timeline targeting AMA CPT Editorial Panel September 2024 meeting (submission deadline June 28, 2024), LCD filing target August 2024, workstream assignments
5 | LCD-MolDx | LCD Regulatory Landscape Memorandum — Medicare Coverage for NGS-Based Oncology Diagnostics | C&H (Sean Morrissey, Christopher Aiken) | 2024-03-01 | Late February 2024 | Completed | Item 4 | Background research memo: overview of Medicare coverage landscape for NGS-based oncology diagnostics, survey of existing LCDs/NCDs, MolDx program requirements, recent CMS policy developments. Foundation document for strategy development.
6 | Coding Strategy | Coding Strategy Memorandum — PLA Code vs. CPT Code Analysis for OncoPrecise GXP-47 | C&H (Morrissey, Aiken) to GDT (Nakamura, Driscoll) | 2024-03-11 | 2024-03-11 | Completed | Item 4 | Recommended pursuing PLA code over existing CPT 81455 to capture proprietary TRI algorithm and support premium reimbursement rate. Included proposed PLA code 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.'
7 | Engagement Admin | Invoice No. INV-1043-00002-001 issued (period 2/14–3/14/2024) | C&H (Joel Strauss, Billing Partner) | 2024-03-15 | 2024-03-15 | Completed | — | Amount: $62,437.50. Status: PAID.
8 | Coding Strategy | Draft PLA code application transmitted to Carraway Regulatory Advisors for review | C&H (Christopher Aiken) to Carraway (Janet Carraway) | 2024-03-18 | 2024-03-18 | Completed | Item 6 | Email from Aiken to Carraway requesting review of draft PLA application, coding mechanics input, and AMA submission formatting prior to March 22 delivery to GDT. CC: Morrissey, Driscoll.
9 | Coding Strategy | Draft PLA Code Application — OncoPrecise GXP-47 delivered to GDT | C&H (Aiken, Morrissey) / Carraway (Janet Carraway) | 2024-03-22 | 2024-03-22 | Completed | Item 8 | Includes proposed code descriptor, test methodology, clinical indications (Stage IIIB/IV NSCLC, ICI therapy response prediction), specimen type (FFPE), lab info (CLIA No. 05D2187432, NPI 1902847365). Targeted for AMA CPT Editorial Panel September 2024 meeting; submission deadline June 28, 2024. Draft cover letter also prepared (Aiken, reviewed by Calloway).
10 | Clinical Evidence | CLARITY-LUNG interim analysis results released | GDT (Dr. Priya Sundaram, VP Clinical Development / PI) | N/A (external) | 2024-03-29 | Completed | — | Interim analysis at 50% enrollment (n=600): PPV = 0.68 (target ≥ 0.75); NPV = 0.71 (target ≥ 0.80). Neither met pre-specified thresholds. CRITICAL EVENT — triggered strategy reassessment.
11 | Clinical Evidence | C&H preliminary assessment email — impact of CLARITY-LUNG interim results | C&H (Miriam Calloway) to GDT (Nakamura) | — | 2024-04-01 | Completed | Item 10 | Calloway to Nakamura (cc: Driscoll, Morrissey). Flagged PPV 0.68 and NPV 0.71 below pre-specified thresholds; discussed potential impact on LCD filing timeline and MolDx technical assessment. Noted detailed Clinical Evidence Gap Analysis memorandum to follow.
12 | Clinical Evidence | DSMB meeting — CLARITY-LUNG trial | DSMB Chair: Dr. Evelyn Matsuda (Carrington Cancer Institute) | N/A (external) | 2024-04-05 | Completed | Item 10 | DSMB recommended continuing enrollment but noted interim results 'inconclusive and below pre-specified performance benchmarks.' Enrollment as of meeting: progressing toward 847 of 1,200 target (70.58%).
13 | Board-Investor | GDT board meeting — request to reassess LCD filing strategy | GDT Board (Dr. Raval, Chair; Dr. Yuen; Marchetti; Ashford; Dr. Mosley; Hwang; Odom) | N/A (external) | 2024-04-09 | Completed | Items 10, 12 | Board directed C&H to reassess LCD filing strategy in light of CLARITY-LUNG interim data. C&H acknowledged via email from Calloway to Nakamura (April 10, 2024), outlining scope of revised analysis and estimated delivery timeline.
14 | Clinical Evidence | Clinical Evidence Gap Analysis Memorandum delivered | C&H (Calloway, Morrissey) to GDT (Nakamura, Driscoll, Dr. Sundaram) | 2024-04-15 | 2024-04-15 | Completed | Items 10, 13 | Analyzed impact of CLARITY-LUNG interim results (PPV 0.68, NPV 0.71) on LCD application and MolDx technical assessment. Identified evidence gaps, assessed risk of non-coverage determination from CFI/RAS based on current data, evaluated supplemental evidence strategies including retrospective studies and sub-group analyses.
15 | Engagement Admin | Invoice No. INV-1043-00002-002 issued (period 3/15–4/14/2024) | C&H (Joel Strauss) | 2024-04-15 | 2024-04-15 | Completed | — | Amount: $78,747.62. Reflects PLA application drafting, CLARITY-LUNG interim results analysis, clinical evidence gap analysis work. Status: PAID.
16 | LCD-MolDx | Revised LCD/MolDx Strategy Memorandum — Recommendation to Defer LCD Filing | C&H (Calloway, Morrissey) to GDT (Nakamura, Driscoll) | 2024-04-22 | 2024-04-22 | Completed | Items 13, 14 | Recommended deferral of LCD filing with Cascade Fiscal Intermediaries (CFI) and MolDx technical assessment submission to Ridgeline Administrative Services (RAS) until final CLARITY-LUNG data available (revised projection Q2 2025). Discussed risks of premature filing, precedent of non-coverage for tests with inconclusive validation data, alternative timeline options. Prepared per GDT board direction from April 9, 2024 meeting.
17 | LCD-MolDx | Draft MolDx Technical Assessment Dossier (Version 1.0) delivered | C&H (Morrissey, Aiken) to GDT | 2024-04-30 | 2024-04-30 | Completed | Items 14, 16 | Contains: (1) test description and intended use for Stage IIIB/IV NSCLC; (2) analytical validation data summary (completed Dec 2022, published JMOD Vol. 18, Issue 4, pp. 412–429); (3) clinical validation data from CLARITY-LUNG interim + prior retrospective studies; (4) clinical utility evidence; (5) health economic analysis (incorporating Larkfield Health Economics work product, reviewed per C&H internal HEOR review memo); (6) bibliography of 43 peer-reviewed publications. Status: NEVER SUBMITTED to RAS.
18 | Board-Investor | GDT internal commercial launch review meeting | GDT (Nakamura, Driscoll, Ota, Dr. Raval) / Verdant Life Sciences Capital (Christine Lau, MD) | N/A (external) | 2024-05-06 | Completed | Item 16 | Verdant presented revised financial models reflecting delayed launch. Revenue projections: Year 1 volume 8,500 tests, 62% Medicare mix, target rate $3,850/test → 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.
19 | NCD | NCD Feasibility Assessment Memorandum delivered | C&H (Calloway, Strauss) to GDT (Nakamura, Driscoll, Dr. Raval) | 2024-05-10 | 2024-05-10 | Completed | Item 16 | Assessed feasibility/timeline for NCD through CMS including Coverage with Evidence Development (CED) framework and traditional NCD pathway. Estimated NCD timeline: 18–24 months from LCD issuance. Recommended LCD first before NCD. Transmitted via email from Calloway to Nakamura (cc: Driscoll, Dr. Raval, Morrissey).
20 | Reimbursement Rate | Reimbursement Rate Analysis Memorandum — Crosswalk/Gapfill Pricing delivered | C&H (Morrissey, Aiken) to GDT (Driscoll, Ota) | 2024-05-14 | 2024-05-14 | Completed | Item 9 | Crosswalk 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 avg: $3,622.33. Target $3,850/test = 6.28% premium justified by proprietary TRI algorithm. Includes gapfill alternative. Accompanied by Excel workbook (Reimbursement Rate Crosswalk Model).
21 | Board-Investor | Pinnacle Health Ventures (Elena Marchetti) formally recommends deferring OncoPrecise GXP-47 launch | PHV (Elena Marchetti, Partner / GDT Board Member) | N/A (external) | 2024-05-17 | Completed | Items 16, 18 | PHV holds 41.3% of GDT fully diluted equity; retained observer rights over all material commercialization and reimbursement decisions. Robert Garner (Ashby & Garner, LLP) advised PHV.
22 | Board-Investor | GDT board resolves to defer commercial launch of OncoPrecise GXP-47 indefinitely | GDT Board | N/A (external) | 2024-05-22 | Completed | Item 21 | Resolution driven by inconclusive CLARITY-LUNG interim results and PHV's formal recommendation. CLARITY-LUNG enrollment at ~847/1,200 (70.58%); trial expenditures $19.1M of $28.5M budget (67.02%). Final data readout revised to Q2 2025.
23 | Wind-Down | GDT instructs Calderwood & Harkness to wind down engagement | GDT (Theresa Nakamura) to C&H (Miriam Calloway) | — | 2024-05-23 | Completed | Item 22 | Email from Nakamura to Calloway (cc: Driscoll, Morrissey). Communicated board's May 22 resolution. Instructed C&H to wind down, prepare work product preservation summary, issue final invoice.
24 | Wind-Down | Coordination email — C&H to Whitford & Sable LLP re: board matters and PCNB covenant | C&H (Miriam Calloway) to W&S (Harrison Whitford) | — | 2024-05-24 | Completed | Items 22, 23 | CC: Nakamura, Danielle Reeves (W&S). Coordinated re: launch deferral and potential PCNB milestone covenant issue under Section 7.14 of Revolving Facility (Ref. PCNB-GDT-RF-2023-0922). Discussed whether existing GXP-12 LCD (L38472, effective 2021-08-15, issued by CFI) satisfies covenant requiring GDT to 'obtain' a Medicare coverage determination by Dec 31, 2024.
25 | Wind-Down | Matter Wind-Down Memorandum, Work Product Index, and PCNB Covenant Analysis Memorandum delivered | C&H (Calloway) to GDT (Nakamura) | 2024-05-28 | 2024-05-28 | Completed | Item 23 | Wind-Down Memo: summarized all work product, identified pending deliverables not to be completed (PLA submission, LCD filing, MolDx dossier finalization), outlined preservation and retention arrangements, recommendations for reactivation. PCNB Covenant Analysis: Section 7.14 requires 'obtain a final Medicare coverage determination' by Dec 31, 2024; $9.2M outstanding on $15M facility (SOFR + 3.75%); 90-day cure period expires March 31, 2025; argument that 'obtain' (future tense) may require new determination vs. existing GXP-12 LCD. Transmitted via email (cc: Driscoll, Strauss, Morrissey).
26 | Wind-Down | Matter formally closed/terminated | C&H (Calloway) | 2024-06-03 | 2024-06-03 | Completed | Item 25 | Formal matter closure letter from Calloway to Nakamura. Matter No. 1043-00002. Referenced wind-down memo and work product preservation. Noted document retention policy, statute of limitations considerations, offered to reactivate if GDT resumes GXP-47 commercialization.
27 | Engagement Admin | Invoice No. INV-1043-00002-003 (Final) issued (period 4/15–6/3/2024) | C&H (Joel Strauss) | 2024-06-10 | 2024-06-10 | Completed | Item 26 | Amount: $79,592.56 (includes disbursements: Westlaw $1,875.50, printing $214.68, travel $250.00 = $2,340.18 total disbursements). Partial payment $6,000 received. Outstanding balance: $73,592.56. Total billed all invoices: $220,777.68. Total actual fees: $218,437.50.
28 | Board-Investor | Pacific Coast National Bank notified of potential milestone covenant issue | GDT (Nakamura / Ota) to PCNB (Thomas Becerra) | — | 2024-06-24 | Completed | Items 22, 25 | Notification re: potential inability to satisfy Section 7.14 milestone covenant by December 31, 2024 testing date. Facility maturity: September 22, 2026.
29 | Regulatory Deadline | PLA code application submission deadline — AMA CPT Editorial Panel (September 2024 meeting) | C&H / GDT / Carraway | 2024-06-28 | — | MISSED / Not Submitted | Item 26 | Application was never submitted due to matter termination on June 3, 2024. Draft PLA code application and cover letter preserved in work product files.
30 | Regulatory Deadline | LCD filing target with Cascade Fiscal Intermediaries (CFI) / MolDx submission to Ridgeline Administrative Services (RAS) | C&H / GDT | August 2024 | — | Cancelled | Item 29 | Original target post-PLA code assignment. Draft LCD request letter (to Dr. William Hargrove, Medical Director; Sandra Phu, LCD Analyst, CFI) and MolDx dossier (v1.0) preserved but never submitted. Recommended deferral until final CLARITY-LUNG data (Q2 2025).
31 | Regulatory Deadline | AMA CPT Editorial Panel September 2024 meeting | AMA | 2024-09-22 | — | N/A — GDT did not submit | Item 29 | GDT's PLA code application was not submitted; no action taken at this meeting.
32 | Regulatory Deadline | PCNB milestone covenant testing date (Section 7.14) | Pacific Coast National Bank | 2024-12-31 | — | Pending | Item 28 | Covenant requires GDT to obtain a final Medicare coverage determination for at least one proprietary LDT by this date. Potential argument re: existing GXP-12 LCD L38472 (effective 2021-08-15). See PCNB Covenant Analysis Memo.
33 | Regulatory Deadline | PCNB milestone covenant cure period expiration | Pacific Coast National Bank / GDT | 2025-03-31 | — | Pending | Item 32 | 90-day cure period from covenant testing date of December 31, 2024.
34 | Clinical Evidence | Revised projected CLARITY-LUNG final data readout | GDT (Dr. Sundaram) | Q2 2025 | — | Pending | Items 10, 22 | Originally projected Q4 2024; revised to Q2 2025 following inconclusive interim results. Trial ID: NCT05891247. Enrollment target: 1,200 patients across 14 U.S. sites.
[sheet: Deliverables Log]
Deliverable # | Deliverable Title | Document Type | Author(s) | Reviewed By | Recipient(s) | Date Delivered | Status | File Reference | Notes
1 | LCD Regulatory Landscape Memorandum — Medicare Coverage for NGS-Based Oncology Diagnostics | Memorandum | Sean Morrissey, Christopher Aiken | Miriam Calloway | Internal (C&H team) | Late Feb 2024 | Delivered | lcd-regulatory-landscape-memo.docx | Background research memo; foundation for strategy development
2 | Coding Strategy Memorandum — PLA Code vs. CPT Code Analysis for OncoPrecise GXP-47 | Memorandum | Sean Morrissey, Christopher Aiken | Miriam Calloway | GDT (Nakamura, Driscoll) | 2024-03-11 | Delivered | coding-strategy-memorandum.docx | Recommended PLA code over CPT 81455; proposed PLA descriptor included
3 | Draft PLA Code Application — OncoPrecise GXP-47 | Application | Christopher Aiken, Sean Morrissey; Carraway Regulatory Advisors (Janet Carraway) | Miriam Calloway | GDT (Nakamura, Driscoll) | 2024-03-22 | Draft — Not Submitted | draft-pla-code-application.docx | Targeted AMA CPT Editorial Panel Sept 2024 meeting (deadline June 28, 2024). Never submitted due to matter termination June 3, 2024.
4 | Draft Cover Letter — PLA Code Application Submission to AMA CPT Editorial Panel | Letter | Christopher Aiken | Miriam Calloway | AMA CPT Editorial Panel (intended) | 2024-03-22 | Draft — Never Sent | pla-code-application-cover-letter-draft.docx | Referenced analytical validation publication (JMOD Vol. 18, Issue 4, pp. 412–429, Dec 2022). Never sent.
5 | Clinical Evidence Gap Analysis Memorandum | Memorandum | Miriam Calloway, Sean Morrissey | — | GDT (Nakamura, Driscoll, Dr. Sundaram) | 2024-04-15 | Delivered | clinical-evidence-gap-analysis.docx | Analysis of CLARITY-LUNG interim results impact (PPV 0.68, NPV 0.71 vs. targets ≥0.75, ≥0.80)
6 | Revised LCD/MolDx Strategy Memorandum — Recommendation to Defer LCD Filing | Memorandum | Miriam Calloway, Sean Morrissey | — | GDT (Nakamura, Driscoll) | 2024-04-22 | Delivered | revised-lcd-moldx-strategy-memo.docx | Recommended deferral until final CLARITY-LUNG data (Q2 2025). Prepared per GDT board direction (April 9, 2024).
7 | Draft MolDx Technical Assessment Dossier — OncoPrecise GXP-47 (Version 1.0) | Dossier | Sean Morrissey, Christopher Aiken | Miriam Calloway | GDT | 2024-04-30 | Draft — Not Submitted | draft-moldx-technical-assessment-dossier-v1.docx | Intended for submission to Ridgeline Administrative Services (RAS / Dr. Catherine Embry). Includes 43-publication bibliography. Never submitted.
8 | MolDx Technical Assessment Dossier — Bibliography (43 Publications) | Dossier Appendix | Sean Morrissey, Christopher Aiken | Miriam Calloway | GDT (with Dossier v1.0) | 2024-04-30 | Delivered (as part of v1.0) | moldx-dossier-bibliography.docx | Annotated bibliography organized by: analytical validation, clinical validation, clinical utility, health economics, ICI/NSCLC background literature
9 | Review Memorandum — Larkfield Health Economics HEOR Analysis for MolDx Dossier | Memorandum | Sean Morrissey | Miriam Calloway | Internal (C&H team) | ~April 2024 | Delivered | larkfield-heor-review-memo.docx | Review of Larkfield (Dr. Nathan Ostroff) HEOR work product for incorporation into MolDx dossier. Identified revision areas, flagged regulatory compliance considerations.
10 | NCD Feasibility Assessment Memorandum | Memorandum | Miriam Calloway, Joel Strauss | — | GDT (Nakamura, Driscoll, Dr. Raval) | 2024-05-10 | Delivered | ncd-feasibility-assessment-memo.docx | NCD timeline 18–24 months from LCD. CED framework analysis. Recommend LCD first.
11 | Reimbursement Rate Analysis Memorandum — Crosswalk/Gapfill Pricing | Memorandum | Sean Morrissey, Christopher Aiken | Miriam Calloway | GDT (Driscoll, Ota) | 2024-05-14 | Delivered | reimbursement-rate-analysis-memo.docx | Target $3,850/test; 6.28% premium over weighted avg $3,622.33. Comparators: Elara 0250U $3,742, CPT 81455 $2,919, Marlowe Asset Management 0239U $4,206.
12 | Reimbursement Rate Crosswalk Model (Excel) | Spreadsheet | Sean Morrissey, Christopher Aiken | Miriam Calloway | GDT (Driscoll, Ota) | 2024-05-14 | Delivered | reimbursement-rate-model.xlsx | Tabs: crosswalk comparator analysis, premium justification, revenue projection sensitivity (Year 1–3), gapfill pricing scenario
13 | Draft LCD Request Letter to Cascade Fiscal Intermediaries, LLC | Letter | Sean Morrissey | Miriam Calloway | CFI (Dr. William Hargrove, Sandra Phu) — intended | ~April–May 2024 | Draft — Never Sent | draft-lcd-request-letter.docx | To be signed by Dr. Anisha Raval (CEO). Target filing August 2024. Never sent.
14 | GDT Board Presentation — OncoPrecise GXP-47 Medicare Coverage & Coding Strategy Overview | Presentation | Miriam Calloway, Sean Morrissey | — | GDT Board (presented April 9, 2024) | 2024-04-09 | Delivered | board-presentation-coverage-strategy.pptx | Summarized reimbursement strategy, PLA coding, LCD/MolDx pathway, NCD considerations, CLARITY-LUNG interim impact, target rate $3,850, revenue projections, recommended next steps
15 | Analysis of Pacific Coast National Bank Milestone Covenant — Impact of Launch Deferral | Memorandum | Miriam Calloway, Sean Morrissey | — | GDT (Nakamura, Ota) | 2024-05-28 | Delivered | pcnb-covenant-analysis-memo.docx | Section 7.14 analysis; $9.2M outstanding on $15M facility; existing GXP-12 LCD L38472 argument; 'obtain' future tense issue; covenant testing Dec 31, 2024; 90-day cure to March 31, 2025
16 | Matter Wind-Down Memorandum and Work Product Preservation Summary | Memorandum | Miriam Calloway | — | GDT (Nakamura) | 2024-05-28 | Delivered | matter-wind-down-memo.docx | Per GDT's May 23 wind-down instruction. Identified pending deliverables not completed. Recommendations for reactivation upon commercial launch resumption.
17 | Work Product Index and Deliverables Tracker | Spreadsheet | Sean Morrissey | Miriam Calloway | GDT (Nakamura) | 2024-05-28 | Delivered | work-product-index.xlsx | Catalog of all work product; attached to Wind-Down Memo
18 | Matter Closure Letter | Letter | Miriam Calloway | — | GDT (Nakamura) | 2024-06-03 | Delivered | letter-calloway-to-nakamura-matter-closure.docx | Formal closure of Matter No. 1043-00002
[sheet: Key Dates & Deadlines]
Deadline / Event | Date | Type | Original Plan | Current Status as of June 3, 2024 | Impact of Deferral
PLA code application submission deadline (AMA CPT Editorial Panel — Sept 2024 meeting) | 2024-06-28 | Regulatory | Submit by June 28, 2024 | MISSED — application not submitted; matter terminated June 3, 2024 | No PLA code assigned for GXP-47; cannot proceed to LCD filing on original timeline
LCD filing target with Cascade Fiscal Intermediaries (CFI) | August 2024 | Regulatory | File LCD request and MolDx dossier with CFI/RAS post-PLA code assignment | Cancelled — per Revised LCD/MolDx Strategy Memo (April 22, 2024) recommending deferral until final CLARITY-LUNG data | LCD not pursued; no Medicare coverage determination for GXP-47 on current timeline
AMA CPT Editorial Panel September 2024 meeting | 2024-09-22 | Regulatory | GXP-47 PLA code application to be considered | N/A — GDT did not submit application | Next available AMA meeting cycle would need to be targeted upon matter reactivation
PCNB milestone covenant testing date (Section 7.14) | 2024-12-31 | Contractual | GXP-47 LCD expected to satisfy covenant | At risk — GXP-47 launch deferred; argument being evaluated whether existing GXP-12 LCD (L38472, eff. 2021-08-15) satisfies 'obtain' language | PCNB notified June 24, 2024 (Thomas Becerra). $9.2M outstanding on $15M revolving facility (Ref. PCNB-GDT-RF-2023-0922). Interest: SOFR + 3.75%.
PCNB milestone covenant cure period expiration | 2025-03-31 | Contractual | 90-day cure period from Dec 31, 2024 testing date | Pending — cure period not yet triggered | If covenant breach determined, GDT has until March 31, 2025 to cure
CLARITY-LUNG final data readout (revised projection) | Q2 2025 | Clinical | Originally Q4 2024; revised after inconclusive interim results | Pending — trial continuing per DSMB recommendation | CLARITY-LUNG ID: NCT05891247. Trial budget: $28.5M; $19.1M expended through May 2024 (67.02%). Enrollment: 847/1,200 (70.58%). Final data needed before reactivation of reimbursement strategy.
PCNB Revolving Facility maturity | 2026-09-22 | Contractual | 3-year term from September 22, 2023 execution | Active — $9.2M drawn of $15M facility | Maturity provides outer boundary for resolution of covenant issue
[sheet: Engagement Financials]
Timekeeper | Role | Hourly Rate | Total Hours | Billed Hours | Written-Off Hours | Total Fees | Notes
Miriam Calloway | Responsible Partner | $1,350 | 42.5 | 42.5 | 0 | $57,375.00 | Washington, D.C. office; 28 years experience
Joel Strauss | Billing Partner | $1,275 | 18 | 18 | 0 | $22,950.00 | San Francisco office; health technology assessment / FDA-CMS regulatory
Sean Morrissey | Lead Associate (Senior) | $875 | 98.5 | 98.5 | 0 | $86,187.50 | Washington, D.C. office; 6 years experience; former CMS Coverage & Brightmoor Strategy Partners policy analyst
Christopher Aiken | Working Associate | $650 | 72 | 71.8 | 0.2 | $46,670.00 | San Francisco office; 3 years experience; CPT/HCPCS coding focus. 0.2 hrs written off ($130)
Paralegals | Paralegal Support | $375 | 14 | 14 | 0 | $5,250.00
TOTAL FEES | 245 | 244.8 | 0.2 | $218,432.50 | Subtotal before reconciliation adjustment. Per final invoice reconciliation with minor disbursements of $5.00: actual fees = $218,437.50
[sheet: Invoice Summary]
Invoice Number | Invoice Date | Billing Period | Fees | Disbursements | Total Amount | Amount Paid | Outstanding Balance | Status
INV-1043-00002-001 | 2024-03-15 | 2/14/2024 – 3/14/2024 | $62,437.50 | $0.00 | $62,437.50 | $62,437.50 | $0.00 | PAID
INV-1043-00002-002 | 2024-04-15 | 3/15/2024 – 4/14/2024 | $78,747.62 | $0.00 | $78,747.62 | $78,747.62 | $0.00 | PAID
INV-1043-00002-003 | 2024-06-10 | 4/15/2024 – 6/3/2024 | $77,252.38 | $2,340.18 | $79,592.56 | $6,000.00 | $73,592.56 | Partial Payment — Outstanding
TOTALS | $218,437.50 | $2,340.18 | $220,777.68 | $147,185.12 | $73,592.56
[sheet: Stakeholder Contacts]
Organization | Full Legal Name | Role in Engagement | Key Contact Name | Title | Location | Notes
GDT | Genome Dx Therapeutics Inc. | Client | Theresa Nakamura | General Counsel & VP of Regulatory Affairs | 4720 Torrey Pines Road, Suite 300, San Diego, CA 92130 | Primary contact for C&H engagement; JD (Georgetown); former associate at Whitford & Sable LLP
GDT | Genome Dx Therapeutics Inc. | Client — Day-to-day reimbursement lead | Kevin Driscoll | VP of Market Access & Reimbursement | San Diego, CA | MBA (Wharton); former reimbursement director at Meridian Molecular Labs
GDT | Genome Dx Therapeutics Inc. | Client — CEO / Board Chair | Dr. Anisha Raval | Co-Founder & CEO | San Diego, CA | PhD in Molecular Biology (Stanford); co-founded GDT 2018
GDT | Genome Dx Therapeutics Inc. | Client — CSO / Board Member | Dr. Marcus Yuen | Co-Founder & CSO | San Diego, CA | MD/PhD (UCSF); oversees assay development and clinical validation
GDT | Genome Dx Therapeutics Inc. | Client — Clinical Development / CLARITY-LUNG PI | Dr. Priya Sundaram | VP of Clinical Development | San Diego, CA | MD (Johns Hopkins); principal investigator for CLARITY-LUNG trial (NCT05891247)
GDT | Genome Dx Therapeutics Inc. | Client — CFO | Raymond Ota | Chief Financial Officer | San Diego, CA | CPA, MBA (Chicago Booth); responsible for financial projections tied to Medicare reimbursement modeling
PHV | Pinnacle Health Ventures, L.P. | Majority Investor (41.3% fully diluted); GDT Board | Elena Marchetti | Partner; GDT Board Member | 200 Clarendon Street, 48th Floor, Boston, MA 02116 | Observer rights over commercialization/reimbursement decisions; formally recommended launch deferral May 17, 2024
PHV | Pinnacle Health Ventures, L.P. | Majority Investor; GDT Board | David Ashford | Managing Partner; GDT Board Member | Boston, MA | Led GDT $78M Series C (March 2022)
C&H | Calderwood & Harkness LLP | Outside Counsel — Medicare Coverage & Coding | Miriam Calloway | Responsible Partner, Healthcare & Life Sciences | 1700 K Street NW, Suite 900, Washington, DC 20006 | 28 years experience; 15+ LCD/NCD proceedings
C&H | Calderwood & Harkness LLP | Outside Counsel — Billing Partner | Joel Strauss | Billing Partner, Healthcare & Life Sciences | 555 California Street, Suite 3200, San Francisco, CA 94104 | Health technology assessment; FDA/CMS regulatory intersections
C&H | Calderwood & Harkness LLP | Outside Counsel — Lead Associate | Sean Morrissey | Senior Associate, Healthcare & Life Sciences | Washington, DC | 6 years experience; former CMS Coverage & Brightmoor Strategy Partners policy analyst
C&H | Calderwood & Harkness LLP | Outside Counsel — Working Associate | Christopher Aiken | Associate, Healthcare & Life Sciences | San Francisco, CA | 3 years experience; CPT/HCPCS coding and laboratory billing compliance
CFI | Cascade Fiscal Intermediaries, LLC | Medicare Administrative Contractor (MAC) — Jurisdiction E (CA) | Dr. William Hargrove | Medical Director (Molecular Dx Coverage) | 2800 SW Moody Avenue, Suite 500, Portland, OR 97201 | MD, FACP; responsible for molecular diagnostics coverage determinations
CFI | Cascade Fiscal Intermediaries, LLC | MAC — LCD Analyst | Sandra Phu | LCD Analyst (Genomic Diagnostics) | Portland, OR | Assigned to GDT's genomic diagnostic LCD application (not filed)
RAS | Ridgeline Administrative Services, LLC | MolDx Program Administrator | Dr. Catherine Embry | MolDx Technical Assessment Director | 1600 Hampton Street, Suite 700, Columbia, SC 29201 | PhD; reviews molecular diagnostic test dossiers for Medicare coverage
Carraway | Carraway Regulatory Advisors, Inc. | Coding & Billing Consultant (retained by GDT) | Janet Carraway | Principal | 233 South Wacker Drive, Suite 4100, Chicago, IL 60606 | CPC, CCS-P; worked alongside C&H on coding strategy and PLA application
Larkfield | Larkfield Health Economics, LLC | HEOR Consultant (retained by GDT) | Dr. Nathan Ostroff | Principal Consultant | 7910 Woodmont Avenue, Suite 610, Bethesda, MD 20814 | PhD, MS; prepared clinical utility and cost-effectiveness analyses for MolDx dossier
W&S | Whitford & Sable LLP | GDT Regular Outside Counsel (Corporate/IP) | Harrison Whitford | Lead Partner | 501 West Broadway, Suite 1400, San Diego, CA 92101 | Not involved in reimbursement engagement but coordinated on regulatory/corporate board matters
W&S | Whitford & Sable LLP | GDT Regular Outside Counsel — Coordination | Danielle Reeves | Associate | San Diego, CA | Handling coordination between W&S and C&H
A&G | Ashby & Garner, LLP | PHV Outside Counsel (Portfolio Matters) | Robert Garner | Partner | 599 Lexington Avenue, 22nd Floor, New York, NY 10022 | Reviewed board-level decisions related to launch deferral
Verdant | Verdant Life Sciences Capital, LLC | Investment Bank / Financial Advisor (GDT) | Christine Lau | Managing Director | 101 Montgomery Street, Suite 2600, San Francisco, CA 94104 | Pre-commercial valuation / Series D or IPO planning; modeled GXP-47 Medicare reimbursement revenue
PCNB | Pacific Coast National Bank | Commercial Lender (GDT Revolving Facility) | Thomas Becerra | Relationship Manager | 633 West 5th Street, 18th Floor, Los Angeles, CA 90071 | $15M revolving facility (Ref. PCNB-GDT-RF-2023-0922); $9.2M outstanding; SOFR + 3.75%; maturity 9/22/2026; milestone covenant Sec. 7.14
Hawthorne | Hawthorne Mutual Insurance Company | D&O and Professional Liability Insurer (GDT) | Megan Forsythe | Underwriter | 280 Trumbull Street, Suite 1200, Hartford, CT 06103 | D&O: $10M (Policy HMI-DL-2023-04891); Prof. Liability: $5M (Policy HMI-PL-2023-07234)
Summit Ridge | Summit Ridge Accounting Group, LLP | Independent Auditor (GDT) | Brian Castellano | Engagement Partner (CPA) | 1250 Sixth Avenue, Suite 800, San Diego, CA 92101 | Performed GDT FY2023 audit
Carrington | Carrington Cancer Institute | DSMB Chair Affiliation | Dr. Evelyn Matsuda | DSMB Chair (CLARITY-LUNG) | 7500 Fannin Street, Houston, TX 77054 | MD, PhD; independent; chaired DSMB meeting April 5, 2024
GDT Board | Genome Dx Therapeutics Inc. | Independent Board Member | Dr. Franklin Mosley | Independent Director | — | Former CMO of Harborview Diagnostics, Inc.
GDT Board | Genome Dx Therapeutics Inc. | Independent Board Member | Catherine Hwang | Independent Director | — | Former CFO of Altius Biosciences, Inc.
Westbrook | Westbrook Life Sciences Fund, L.P. | Series B Investor — GDT Board Representative | Reginald Odom | Board Member | — | Westbrook Life Sciences Fund, L.P. (Delaware LP)