Ann: Mesoblast Maintains Momentum with FDA, page-195

Two things- VERDUN got stood down over Duchenne, which Prasad has previously publicly critiqued Marks for approving.
- An OFF THE SHELF STEM CELL THERAPY JUST CURED DIABETES- n=12 , 10 out of 12 no longer required insulin.

Reg, keeper of the faith, spiritual enigma and supporter of the meek- just in case they do inherit a windfall .


https://www.statnews.com/2025/06/20/fda-ouster-top-gene-therapy-official-nicole-verdun-placed-on-leave-after-review-committee-canceled/

The ouster of the Food and Drug Administration’s chief regulator of cell and gene therapies earlier this week came immediately after a disagreement with her boss over the review of a cell therapy for Duchenne muscular dystrophy, STAT has learned.

The regulator, Nicole Verdun, had scheduled an advisory committee meeting to review the therapy developed by Capricor Therapeutics. But Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, was skeptical of the treatment and decided unilaterally to cancel the meeting, according to a person familiar with the matter.

https://news.vrtx.com/news-releases/news-release-details/vertex-presents-positive-data-zimislecel-type-1-diabetes

Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions

–Results from the study continue to demonstrate the transformative potential of zimislecel with consistent and durable patient benefit–

– All 12 patients with at least one year of follow-up who received a full dose of zimislecel as a single infusion achievedADA-recommended target HbA1c levels <7% and >70% time-in-range (70-180 mg/dL), and 10/12 patients were insulin free –

–Data presented atADAsimultaneously published in theNew England Journal of Medicine–