Here is a summary of FDA Director Janet Woodcockâ€
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Posted On: 03/06/2021 3:21:29 PM
Here is a summary of FDA Director Janet Woodcock’s comments about S/C Treatments:
The FDA acknowledged that normal P-Factor is a higher bar than they want to set to evaluate Treatments for S/C during a pandemic. It is still highly useful, but trial time, size and logistical constraints during COVID are creating barriers to meeting traditional statistical significance for endpoints, and they are willing to take more risk with Severe/Critical trials.
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 until data warrants 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.
May be this will bring sunshine Monday to the SP...
The FDA acknowledged that normal P-Factor is a higher bar than they want to set to evaluate Treatments for S/C during a pandemic. It is still highly useful, but trial time, size and logistical constraints during COVID are creating barriers to meeting traditional statistical significance for endpoints, and they are willing to take more risk with Severe/Critical trials.
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 until data warrants 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.
May be this will bring sunshine Monday to the SP...
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