EUA, from what I understand of it, appears well wi
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Posted On: 08/13/2020 12:08:00 AM
EUA, from what I understand of it, appears well within reach based on the CD10 results. Requirements for EUA (edited to highlight the important points) are below:
-HHS Secretary must declare that circumstances exist justifying the authorization based on a determination by the Secretary of HHS that there is a public health emergency CHECK
-After the Secretary of HHS issues an EUA declaration and after consulting (to the extent feasible and appropriate given the applicable circumstances) with the Assistant Secretary for Preparedness and Response (ASPR), the Director of the National Institutes of Health (NIH), and the Director of CDC,17 the FDA Commissioner may authorize the emergency use of an unapproved product provided that other statutory criteria are met.
-Criteria for Issuance:
Serious or Life-Threatening Disease or Condition
COVID-19CHECK
Evidence of Effectiveness: Medical products that may be considered for an EUA are those that "may be effective"...The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals. FDA intends to assess the potential effectiveness of a possible EUA product on a case-by-case basis using a risk-benefit analysis.
We have positive EIND & now positive Phase II resultsCHECK
Risk-Benefit Analysis: A product may be considered for an EUA if the Commissioner determines that the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product.
It's Safe right? CHECK
-No Alternatives: For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition.
There is no current SOC for mild/moderate, right?CHECK
To conclude, I think based on the above guidance criteria, there's no good reason (politics and shenanigans notwithstanding) why we don't get EUA following submission of CD10 Phase II top-line results. Feedback welcome on my analysis of the approval process.
-HHS Secretary must declare that circumstances exist justifying the authorization based on a determination by the Secretary of HHS that there is a public health emergency CHECK
-After the Secretary of HHS issues an EUA declaration and after consulting (to the extent feasible and appropriate given the applicable circumstances) with the Assistant Secretary for Preparedness and Response (ASPR), the Director of the National Institutes of Health (NIH), and the Director of CDC,17 the FDA Commissioner may authorize the emergency use of an unapproved product provided that other statutory criteria are met.
-Criteria for Issuance:
Serious or Life-Threatening Disease or Condition
COVID-19CHECK
Evidence of Effectiveness: Medical products that may be considered for an EUA are those that "may be effective"...The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals. FDA intends to assess the potential effectiveness of a possible EUA product on a case-by-case basis using a risk-benefit analysis.
We have positive EIND & now positive Phase II resultsCHECK
Risk-Benefit Analysis: A product may be considered for an EUA if the Commissioner determines that the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product.
It's Safe right? CHECK
-No Alternatives: For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition.
There is no current SOC for mild/moderate, right?CHECK
To conclude, I think based on the above guidance criteria, there's no good reason (politics and shenanigans notwithstanding) why we don't get EUA following submission of CD10 Phase II top-line results. Feedback welcome on my analysis of the approval process.
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