Gilead's statement on emergency access to Remdesivir outside of clinical trials.

On March 23, Gilead said it was currently providing an emergency channel for personal compassion use to transition to the expansion access program, which will accelerate access to Remdesivir for severe patients and collect data on all participating patients.
these projects are currently being rapidly developed in conjunction with national regulatory agencies around the world (FDA, CDC, DHHS, NIAID, DoD, CDC, NMPA, WHO, etc.).
by the time of writing, Gilead had launched six clinical trials worldwide.
in-group clinical trials is the primary way to obtain critical data from Remdesivir to generate (inform the appropriate use of the experimental drug).
consideration of emergency treatment requests only if admission to a clinical trial is not a viable option.
Gilead said the "exponential increase" in requests for compassionate use in recent weeks because of the spread of the coronavirus in Europe and the UNITED States had "overwhelmed" its access to treatment system, which was set up for limited access to drugs and had never been intended to be used to deal with a pandemic.
", "In view of the overwhelming demands of the past few days, we cannot accept new requests for compassionate use of individuals during this transition period, except for pregnant women who have been diagnosed with COVID-19 and who exhibit serious related diseases and children under the age of 18."
our current focus is now on processing previously approved applications and expect that the extended use project will be launched within a similar expected time frame, i.e. to process any new compassionate use applications.
noted that on March 13th the White House said Remdesivir was a very promising treatment.
earlier, the New England Journal of Medicine (NEJM) published several papers online on the case of the new coronavirus (2019-nCoV), including one about the first confirmed case in the United States and the clinical manifestations of "an immediate improvement in clinical symptoms after one night of drug use."
References: s1. Emergency Access to Remdesivir Outside of Clinical Trials. Retrieved 2020-03-23, from the original title: Official Xuan. Gilead's statement on emergency access to Remdesivir outside of clinical trials.