INSIDE PHARMA

INSIDE PHARMA

Share this post

INSIDE PHARMA
INSIDE PHARMA
Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy

Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy

Ah ha, the man behind the poison mRNA jabs...revealed in plain sight!

Hedley Rees's avatar
Hedley Rees
Jun 21, 2024
∙ Paid
14

Share this post

INSIDE PHARMA
INSIDE PHARMA
Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy
6
1
Share

INSIDE PHARMA is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

Article from yesterday:

Check this out guys:

Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy

It begins:

“For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy.

On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year. 

That decision, documents concurrently released by the agency show, was made almost exclusively by Peter Marks, the agency’s director of the Center for Biologics Evaluation and Research. He overruled three review teams and two top lieutenants, who wrote that the data Sarepta…

This post is for paid subscribers

Already a paid subscriber? Sign in
© 2025 Hedley Rees
Privacy ∙ Terms ∙ Collection notice
Start writingGet the app
Substack is the home for great culture

Share