Hey Enjay. Hmmm, I didn't know Marketwatch had a p
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Posted On: 10/23/2020 2:17:57 PM
Hey Enjay. Hmmm, I didn't know Marketwatch had a pay wall, but what you pasted is essentially the same story. I would also add:
"At the same time, some medical experts are questioning the basis for the approval and have also wondered why the FDA did not hold an advisory committee meeting to discuss the risks and benefits of the drug. In the traditional FDA approval process, a group of independent clinical experts convenes for a public meeting to discuss experimental therapies before a FDA decision. They vote on whether the agency should approve a drug. The FDA isn’t required to follow the committee’s recommendation, but it often does."
"The FDA’s label for the drug “surprisingly” excludes findings from the two trials conducted in China and the WHO Solidarity trial, according to Raymond James analyst Steven Seedhouse. “In other words, the label excludes negative trials/data for remdesivir,” he wrote in a note to investors."
So it seems favorable treatment by the FDA bordering on unethical. Fast-tracking, skipping steps, and turning a blind eye to negative data.
"At the same time, some medical experts are questioning the basis for the approval and have also wondered why the FDA did not hold an advisory committee meeting to discuss the risks and benefits of the drug. In the traditional FDA approval process, a group of independent clinical experts convenes for a public meeting to discuss experimental therapies before a FDA decision. They vote on whether the agency should approve a drug. The FDA isn’t required to follow the committee’s recommendation, but it often does."
"The FDA’s label for the drug “surprisingly” excludes findings from the two trials conducted in China and the WHO Solidarity trial, according to Raymond James analyst Steven Seedhouse. “In other words, the label excludes negative trials/data for remdesivir,” he wrote in a note to investors."
So it seems favorable treatment by the FDA bordering on unethical. Fast-tracking, skipping steps, and turning a blind eye to negative data.
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