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Gilead seeks rapid FDA approval for Covid-19 vaccine, pushing its stock into the stratosphere!

03-17-2020 08:35 AM CET | Business, Economy, Finances, Banking & Insurance

Press release from: DB Consultancy

Gilead Sciences, Inc. (NASDAQ: GILD) announced the initiation of two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 (novel coronavirus). This randomized, open-label, multicentre studies will enrol approximately 1,000 patients at medical centres primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March. The studies will assess two dosing durations of remdesivir, administered intravenously. The initiation of these studies follows the U.S. Food and Drug Administration's (FDA) rapid review and acceptance of Gilead's investigational new drug (IND) filing for remdesivir for the treatment of COVID-19.
The new clinical studies expand the on-going research into remdesivir, which includes two clinical trials in China's Hubei province led by the China-Japan Friendship Hospital as well as the recently initiated clinical trial in the United States led by the National Institute of Allergy and Infectious Diseases (NIAID). Gilead has donated drug and provided scientific input for these studies, with results from those in China expected in April.
"Gilead's primary focus is on rapidly determining the safety and efficacy of remdesivir as a potential treatment for COVID-19, and this complementary array of studies helps to give us a more expansive breadth of data globally on the drug's profile in a short amount of time. The speed with which remdesivir has moved into clinical development for this coronavirus reflects the pressing need for treatment options and the shared commitment of industry, governments, global health organizations and healthcare providers to respond to this public health threat with the highest urgency," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
The Gilead studies will evaluate two dosing durations of remdesivir. One study will randomize approximately 400 patients with severe clinical manifestations of COVID-19 to receive either five or 10 days of remdesivir. The second study will randomize approximately 600 patients with moderate clinical manifestations of disease to receive five or 10 days of remdesivir or standard of care alone. The primary endpoint of both studies is clinical improvement, as described below.
Remdesivir is not yet licensed or approved anywhere globally though with the pressure the FDA is under, it is only a matter of time. Working with government agencies, non-governmental organizations and local regulatory authorities, Gilead is providing remdesivir to qualified patients with COVID-19 on a compassionate use basis for emergency treatment outside of on-going clinical studies.
About Remdesivir
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens including Ebola, Marburg, MERS and SARS. Remdesivir has been studied in healthy volunteers and in people with Ebola virus infection. Individual compassionate use cases are not sufficient to determine the safety and efficacy of remdesivir in treating COVID-19, which can only be determined through prospective clinical trials.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

Forward Looking Statement
Wall St insider Bob Rubiano along with several European boutique brokerage affiliates like Swiss company Hardman Brookes, purchased institutional blocks of GILD months ago looking to hedge but will now offer small retail positions on a first come first serve basis for non U.S. clients. With the Whitehouse putting the FDA under enormous political pressure to fast track approval on this vaccine, essential clinical trials and already successful treatments* ensure a quick turnaround. WHO, IMF, EB and BoE all recognise Remdesivir has a gone under numerous studies already as a possible treatment for Ebola. On the basis of the successful treatments A level investors have been pumping cash into the drug development and the stock of Gilead.

*The drug has already been used in the treatment of 14 American passengers on a cruise ship recently quarantined in Japan. 5 of whom were in critical condition. All have since returned to the US and are recovering.
A 35-year-old U.S. patient with a form of coronavirus who visited family in Wuhan and returned to Washington State on Jan. 15. Four days later, he went to urgent care with a cough and fever. He was quickly hospitalized. Physicians treated him with remdesivir a week later, according to a recent report from the New England Journal of Medicine. On the eighth day of hospitalization, after receiving Gilead's drug, the man's symptoms were seen to improve. He has since recovered and been released from hospital.

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