Today after their stock went up Gilead announced the following:
Gilead: Anecdotal Reports Do Not Provide Statistical Power Necessary To Determine Safety, Efficacy Profile Of Remdesivir As Treatment For COVID-19 -Expect Data From Phase 3 Study In Patients With Severe Covid-19 Infection To Be Available At End Of April
This is Gilead telling us not to be optimistic yet. This drug has serious side effects according to the study that I linked above:
1 in 4 patients experienced severe side effects, including multiple-organ dysfunction syndrome, septic shock, acute kidney injury and low blood pressure. 23% showed signs of liver damage on lab tests. 4 patients had to stop receiving infusions of the drug entirely.
Today GILD releaseed a statement on remdesivir, saying data is INCONCLUSIVE, no statistical power to determine efficacy, and reports are anecdotal – after its stocks surged after hours.
Gilead issued a statement which suggested that STAT was pumping the stock based on nothing more than “anecdotal reports” to wit:
“We understand the urgent need for a Covid-19 treatment and the resulting interest in data on our investigational antiviral drug remdesivir. The totality of the data need to be analysed in order to draw any conclusions from the trial.”
“Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for Covid-19. We expect the data from our Phase 3 study in patients with severe Covid-19 infection to be available at the end of this month, and additional data from other studies to become available in May.”
Is the new Remdesivir data a game changer? no
production capacity, IV infusion capacity in hospitals, and many other issues.
We need rapid turn-around time for PCR testing first: 6hrs for an average patient please?
— Barton (@Barton_options) April 17, 2020
[RTRS] – GILEAD – ANECDOTAL REPORTS DO NOT PROVIDE STATISTICAL POWER NECESSARY TO DETERMINE SAFETY, EFFICACY PROFILE OF REMDESIVIR AS TREATMENT FOR COVID-19
— FxMacro (@fxmacro) April 16, 2020