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Since the COVID-19 pandemic, the pharmaceutical industry has become an inimitable market. If we are to believe the news stories, several pharmaceutical companies possess the most potential drug or treatment method. It has become a race against the clock, because in several countries the situation is still deteriorating and no research for a vaccination has a breakthrough yet.

Gilead Science Inc. enjoys a lot of attention

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One of the biopharmaceutical companies often mentioned recently is Gilead Science Inc. The mission is to discover and develop innovative medicines and try to answer the demand for unmet medical needs. They fight life-threatening diseases from 35 different countries. Remdesivir is the most recent antiviral product that shows great potential. It’s said to have produced promising results and has been recognized by several governments worldwide. Let’s see where the product is standing.

Remdesivir, wild speculation or panacea?

At first, a lot of positive news has been published about Remdesivir. To what extent are these reports retional or does it perhaps have a somewhat optimistic character? Here is a brief overview of what has passed our review.

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Today, health authorities in South Korea reported that one in three seriously ill patients with COVID-19 had an improved condition after administration of Remdesivir. As a result, many hospital beds can be released more quickly from the hospital. If we look at the figures on which this report is based, we see that there are 27 patients from various hospitals. This means that for 9 patients who were administered Remdesivir their condition improved. For 15 patients the condition remained the same and for 3 patients the condition deteriorated. A critical need here is that it was not examined whether the improvement was related to anything other than Remdesivir, for example the immunity of patients or other therapies. In addition, the results were not compared with the risk group. As a result, we cannot determine that Remdesivir actually improved the condition of 9 patients.

On 10 July, additional data were announced about Remdesivir. It includes a comparative analysis of the Phase 3 SIMPLE-Sever study and a realistic retrospective cohort of critically ill patients with COVID-19. What emerges from the analysis? An improvement in clinical recovery and a 62% reduction in mortality risk compared to standard care. There is also a comment that this remarkable finding has yet to be substantiated by prospective clinical studies. An analysis of the compassionate programme adds that 83% of paediatric patients and 92% of pregnant and postnatal women with varying degrees of COVID-19 virus recovered by day 28. A declining 4% did not survive the virus. There are no known complications with these women after administration of Remdesivir. Gilead is going to investigate this further and recently announced to improve the study of these results in individual cases.

Remdesivir in the United States

In the United States, Remdesivir is not approved by the U.S. Food and Drug Administration (FDA) and the safety and efficacy of Remdesivir for the treatment of COVID-19 has not been established. However, in view of the emergency, the FDA has issued an emergency use authorisation only for hospitalised patients in an emergency situation. Gilead has previously entered into an agreement with the U.S. Department of Health and Human Services (HHS) whereby HHS and the states are responsible for managing and allocating hospitals until the end of September. An analysis – primarily with patients from North America – showed that 74.4% of patients receiving Remdesivir recovered by day 14, versus 59% of patients receiving standard care. Furthermore, the analysis showed that 7.6% of patients treated with Remdesivir died on day 14, significantly lower than the 12.5% of patients who did not use Remdesivir.

“In the United States, Remdesivir (GS-5734™) is only approved for use under an Emergency Use Authorization (EUA) for the treatment of patients with suspected or laboratory confirmed SARS-CoV-2 infection and severe COVID-19.

Gilead Science Inc.

Australia seems to be optimistic

The Australian Health Service stated that Remdesivir is currently the most promising treatment option to shorten admissions times for people suffering from severe coronavirus infections. As a result, the Australian Therapeutic Goods Administration (TGA) has provisionally approved Remdesivir as the first treatment option. As a result, the first COVID-19 treatment in Australia has been approved. If we find out for whom it is intended, the report states that Remdesivir is not available in Australia with the exception of critically ill patients who require oxygen or high-level support to breathe. The TGA also reports that the drug has not been shown to prevent coronavirus infection or to affect milder cases of infection. So why was it approved? The explanation is that based on preliminary clinical data there is a high potential and significant benefits for Australian patients. We cannot determine what the actual benefits are based on the source of the TGA except unofficial documentation.

Gilead seems well on his way, but will it finish?

There is limited clinical data available on Remdesivir. Gilead recognises that serious and unexpected side effects may occur that have not previously been reported. It’s now known that hypersensitivity reactions, including infusion-related and anaphylactic reactions, may occur after administration of Remdesivir. Transaminase increases have also been observed in healthy volunteers and patients with COVID-19 during clinical trials. Therefore, it’s also intended only for patients in hospitals equipped with clinical and laboratory monitoring. Kidney and liver functions should be monitored daily before administration of the Remdesivir and during treatment. This also applies to serum chemistry and haematology. Therefore, Gilead will continue to explore the potential to come up with a COVID-19 medicine as soon as it seems safe and highly effective. The company itself is convinced that at the end of 2020 the investment in the development and production of Remdesivir will exceed $1 billion USD.

There are studies, analyses and data that show that the use of Remdesivir has a positive effect on the healing of patients with COVID-19. It reduces the death toll and discharges patients from the hospital faster. The drug has proven to be ineffective for a majority. Why this is the case needs further investigation. It’s also not clear whether other complications may occur when using Remdesivir. Finally about the stock. It may be that investors feel they will miss the boat if they don’t go on board now, but at the same time it is also insecure as you don’t know where the boat will sail to or even leave the harbor at all.

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