Faulty reasoning signals

• Attempt to Sell a Product or Service - 24.9%
• Negativity Bias - 14.6%
• Framing Effect - 12.9%

Article text

Opinion Adam’s Biotech Scorecard

931 days. The drug approval scandal hiding in plain sight

Why the extra-long delay on a review of Northwest Biotherapeutics’ brain cancer treatment?

Senior Writer, Biotech

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

Northwest Biotherapeutics, a public biotech company developing a treatment for brain cancer, submitted a marketing application to U.K. regulators in late December 2023. The review was supposed to take 150 days, under an expedited regulatory pathway for drugs that address serious unmet medical needs.

As you’re reading this newsletter, two years, six months, and 18 days have elapsed without an approval decision. Why the extra-long delay? Regulators at the U.K’s Medicines and Healthcare products Regulatory Agency, or MHRA, won’t comment, telling anyone who inquires, including me, that it’s up to Northwest Bio to provide an update on its brain cancer treatment, called DCVax.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.

Totals $468 per year

for 3 months, then $399/year

Savings start at 25%!

$300 Annually per user

To read the rest of this story subscribe to STAT+.

biotechnology , Cancer , drug development , Pharmaceuticals , STAT+

Submit a correction request Reprints

Adam's Biotech Scorecard

STAT Plus: Halfway into the year, biotech is booming

STAT Plus: In pancreatic cancer, Patrick Soon-Shiong makes promises he has not kept

STAT Plus: ‘Synthetic lethality’ could trigger another round of biotech M&A

STAT Plus: Does Revolution Medicines’ pancreatic cancer drug have even greater potential?

STAT Plus: An ASCO preview: What to watch for at cancer research’s big meeting