Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Weaknesses In Gilead's Remdesivir Trial Designs Unlikely to Impact Approval Prospects In US

Executive Summary

Urgency of the COVID-19 crisis, political pressure, and trends in FDA reviews all point in favor of Gilead, despite the company's decision to conduct open-label Phase III trials for remdesivir and only one study with a control arm.

You may also be interested in...

COVID-19 Shifts ICER Pricing Targets, Creating New Hurdles For Drug Developers

With a remdesivir analysis pushing cost-recovery models and lower thresholds for cost-effectiveness, ICER's COVID-19 pricing framework will likely result in lower pricing benchmarks for drugs than the group would have issued under its typical analysis framework. Critics say this is the opposite of what should be incentivized in an emergency.

Coronavirus Update: Coalition Aims To Overcome 'Disjointed' COVID-19 Trials, Gilead's Open Label Criticized

NIH's Collins brings together coalition after months of behind-the-scenes work. Meanwhile, Gilead's remdesivir trials are the center of huge expectation and controversy.

FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments

Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs. 


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts