Some folks are not paying attention to the FDA. He
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Posted On: 03/05/2021 10:18:36 PM
Some folks are not paying attention to the FDA. Here is a summary of FDA Director Janet Woodcock’s comments about S/C Treatments and drugs:
- The FDA acknowledged that normal P-Factor is not the bar they want to set to evaluate Treatments for S/C during a pandemic.
- If any Treatment shows good improvement over SOC for S/C patients, the FDA will be inclined to offer an EUA and continue evaluating said Treatment for either full approval or discontinuance of the EUA.
- S/C patients have no choice. Any Treatment that is SAFE and gives them a better chance of survival WILL receive an EUA as the alternative is death.
- The FDA will be looking to pair up viable drugs to improve that chance of survival through partnerships.
- The FDA acknowledged that normal P-Factor is not the bar they want to set to evaluate Treatments for S/C during a pandemic.
- If any Treatment shows good improvement over SOC for S/C patients, the FDA will be inclined to offer an EUA and continue evaluating said Treatment for either full approval or discontinuance of the EUA.
- S/C patients have no choice. Any Treatment that is SAFE and gives them a better chance of survival WILL receive an EUA as the alternative is death.
- The FDA will be looking to pair up viable drugs to improve that chance of survival through partnerships.
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