By Caribbean News Global 
WASHINGTON, USA – The coronavirus fighting drug the US Food and Drug Administration (FDA) issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease, will be in the hands of doctors and patients as early as this week, the biotechnology company’s chief executive officer said Sunday.
“We intend to get [remdesivir] to patients in the early part of this next week, beginning to work with the government which will determine which cities are most vulnerable and where the patients are that need this medicine,” Gilead Sciences chairman and chief executive officer Daniel O’Day told CBS’ “Face of the Nation.”
“We’ve donated the entire supply that we have within our supply chain and we did that because we acknowledge and recognize the human suffering, the human need here, and want to make sure nothing gets in the way of this getting to patients,” O’Day added.
“What we will do is provide that donation to the US government and they will determine, based upon things like ICU beds, where the course of the epidemic is in the United States. They will begin shipping tens of thousands of treatment courses out early this week and be adjusting that as the epidemic shifts and evolves in different parts, in different cities in the United States,” O’Day said.
In an open letter from the chairman and chief executive officer, O’Day, April 29, 2020, he said: “The results from the global, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases (NIAID) are positive. They show that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo. There is still more work to do and remdesivir has not been approved, but all of us at Gilead are humbled by what these promising results might mean for patients. After years of research and hard work on remdesivir, there is relief and gratitude among our teams today that their efforts have been so worthwhile.”
Forward-looking statement
“This statement includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19.
“There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized.
“All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s periodic reports filed with the U.S. Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K.
“All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.”
