Posted by MGK_2
•
13h ago
BGT, I took the data points you highlighted and mapped them out into a roadmap. When appreciated this way, June appears to be a massive Data Collision month where the ctDNA and RECIST scans finally overlap for the full CLOVER cohort. It’s hard to call this a theory when we're looking at MD Anderson, City of Hope, and Cornell all moving at once. Great job catching the signals.
The Quiet Period is being replaced by a massive, multi-front clinical offensive heading into the summer.
Clinical & Regulatory Roadmap (Spring/Summer 2026)
April 2026: Milestone Achievement
April 21: CLOVER trial (CRC) reaches full enrollment.
April 30: Webcast confirms a 68% Disease Control Rate (15 of 22 patients) showing tumor shrinkage or stable disease at the first 8-week scan.
Current Status: Reports from trial doctors indicate notable pain reduction in fragile CRC patients; Alzheimer’s study at Cornell and TNBC EAP (funded by a compassionate benefactor) are officially underway.
May 2026: Imminent Launches
CHAMP Trial: Launch of the liver pump delivery study (Dr. Kasi, City of Hope) is imminent.
Earlier-line CRC: Academic institution expected to make a final decision on an earlier-line trial within the next 30 days.
Sovereign Shield: Patent No. 12,624,111 issuance (May 12) provides the legal moat for these combined therapies.
June 2026: Data Convergence
Full ctDNA Profile: Potential for 2-week ctDNA data on the full CLOVER enrollment to be analyzed.
Full RECIST Data: The first 8-week scans (RECIST) for the final CLOVER participants are expected by mid-June, allowing for correlation analysis between ctDNA and imaging.
Summer & Beyond: The "Change" Expands
Q3 2026: PRE-ISPY HER2- Breast Cancer trial (MD Anderson) projected to start within "weeks to a few months."
Pipeline Maturation: Discussions continue for the I-SPY neoadjuvant trial (monotherapy potential) and the Glioblastoma pilot study at a major academic center.
Regulatory Goal: Targeted submission for Fast Track or Breakthrough Designation based on the strength of the consolidated CLOVER and EAP data.
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