NorthWest Biotherapeutics Inc (NWBO)

[antihama]

Hankmanhub, here's potentially another example (i.e. adcomm approval but awaiting regulatory decision)

Amgen and US WorldMeds: A Tale of Data and Two FDA Adcomm Meetings
Published: Oct 06, 2023 By Greg Slabodkin

As FDA Commissioner Robert Califf has argued, the agency’s advisory committee system made up of nearly 50 panels of external experts is “messy” but “hard to imagine a better way of achieving our goals.” This week, the regulator got a view of just how messy the advice of outside experts can be—at least, in the case of US WorldMeds.

Despite the lack of a randomized controlled trial for US WorldMeds’ investigational drug, the FDA’s Oncologic Drugs Advisory Committee in a potentially precedent-setting decision found that the company provided adequate data to support its benefit in high-risk neuroblastoma. In a 14-6 vote, the adcomm determined that US WorldMeds provided enough evidence from a Phase II study to conclude that eflornithine hydrochloride (DFMO) boosts event-free survival in its target pediatric patient population.

While Committee Chair Christopher Lieu, director of the Gastrointestinal Medical Oncology Program at the University of Colorado, voted in favor of DFMO, he warned that the adcomm’s vote on Wednesday might lead to a “slippery slope” in terms of the degree of clinical evidence that will be required for future drug applications in similar rare and difficult-to-study indications.

https://www.biospace.com/article/amgen-and-us-worldmeds-a-tale-of-data-and-two-fda-advisory-committee-meetings/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=277551492&_hsenc=p2ANqtz-_OBfIz8uHQvZTwUISiaJUVnCiGTBEPb5XtfJskRvDyL6c70RwKRqwH7Yna7rqm2T1p5HPSfVSenRSoWB63BIxD_e9w-Q&utm_content=277551492&utm_source=hs_email