'Fauci gives his blessing to remdesivir
The result from Gilead's (NASDAQ:GILD) trial of remdesivir is "quite good news," says "President" Anthony Fauci, with the data showing "clear cut significant positive effect in diminishing the time to recovery." The FDA, he says, is working with Gilead on the availability of the drug.
[...] The primary endpoint was time to improvement, with those on remdesivir showing that in 11 days, and those on placebo 15 days.
The mortality rate on remdesivir was 8% vs. 11% for those on placebo.
[...] The independent Data Monitoring Committee informed him that remdesivir's clinical benefit was "clear-cut" and highly statistically significant (p<0.001). The drug's mortality benefit, while numerically better, is not yet statistically significant. Remdesivir represents a new standard-of-care for COVID-19.'
https://seekingalpha...g-to-remdesivir
'The Food and Drug Administration is likely to issue an emergency approval for remdesivir, a senior administration official told The New York Times. [...]
An emergency authorization by the F.D.A. is not the same as a formal drug approval by the agency. When the federal government declares a public health emergency, the F.D.A. can approve certain drugs or tests to address the emergency if there are no other alternatives. That is the case with the coronavirus, since no drugs have been proven to be effective against the virus.'
https://www.nytimes....ses-deaths.html
Wonder how much control Trump has over the F.D.A.'s emergency approvals....
'Nano cap Capricor Therapeutics (CAPR +180.5%) is up big on a whopping 69x surge in volume in reaction to new data on lead candidate CAP-1002, an off-the-shelf cardiac cell therapy, in severely ill COVID-19 patients.
Six patients were treated on a compassionate care basis. All were suffering from acute respiratory distress syndrome and five were on mechanical ventilator support.
All patients have survived. Four of the five patients on mechanical ventilation were successfully weaned off support within one-to-five days following infusion. The remaining patient remains on mechanical ventilation. The sixth patient is receiving supplemental oxygen and is clinically stable.
[...] The FDA has signed off on expanding the access protocol to include up to 20 additional COVID-19 patients.'
https://seekingalpha...nus-19-patients
This post has been edited by Azath Vitr (D'ivers: 29 April 2020 - 10:05 PM