I wanted to look into what the process is to apply
Post# of 154852
(Total Views: 374)
Posted On: 09/17/2020 10:22:31 AM
I wanted to look into what the process is to apply for and EUA, based on this it looks like Cytodyn was completely right in assuming they should apply. The process seems to encourage applying sooner rather than later. below is a few copy/paste statements from the FDA on EUA submissions:
About Pre-EUA
To help prepare for potential and current emergencies, FDA works with medical countermeasure developers to prepare Pre-EUA packages, when appropriate. A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation. The pre-EUA process allows FDA scientific and technical subject matter experts to begin a review of information and assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA in advance of an emergency and also helps to facilitate complete EUA requests during a current emergency declaration. Please note that a pre-EUA can only transition to an EUA if there is a current applicable emergency declaration.
FDA intends to assess the potential effectiveness of an EUA product on a case-by-case basis. The Agency has
significant experience assessing effectiveness where clinical information is limited, including experience with
treatment INDs and IDEs and humanitarian device exemptions. However, the amount, kind, and quality of
evidence available to support an EUA may not always be the same as that required for treatment INDs, IDEs,
and humanitarian device exemptions under the FD&C Act and Agency regulations. If, based on the totality of
the scientific evidence available, including adequate and well-controlled clinical trials, if they are available, it is
reasonable to believe that the product may be effective for the specified use, the FDA Commissioner may
authorize its emergency use--provided that other statutory criteria (e.g., relating to the risk-benefit analysis
and alternatives) also are met.
Submission of a Request for Consideration: Section 564(c) requires that the data to support
authorization demonstrate that, based on the totality of scientific evidence available to the FDA Commissioner
(including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that the
product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or
condition. The exact type and amount of data needed to support an EUA may vary depending on the nature of
the declared emergency and the nature of the candidate product. To facilitate FDA review of such data, the
Agency recommends that a request for consideration for an EUA include a well-organized summary of the
available scientific evidence that evaluates the product's safety and effectiveness, including the adverse event
profile when used for diagnosis, treatment, or prevention of the serious or life-threatening disease or
condition, as well as data and other information on safety, effectiveness, risks and benefits, and (to the extent
available) alternatives.
I thing given how the FDA expects to receive an application, the data from the M/M is very relevant. I don't think the response is just a cold shoulder from the FDA, it is more of a add to the request with the S/C trial as you get it.
About Pre-EUA
To help prepare for potential and current emergencies, FDA works with medical countermeasure developers to prepare Pre-EUA packages, when appropriate. A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation. The pre-EUA process allows FDA scientific and technical subject matter experts to begin a review of information and assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA in advance of an emergency and also helps to facilitate complete EUA requests during a current emergency declaration. Please note that a pre-EUA can only transition to an EUA if there is a current applicable emergency declaration.
FDA intends to assess the potential effectiveness of an EUA product on a case-by-case basis. The Agency has
significant experience assessing effectiveness where clinical information is limited, including experience with
treatment INDs and IDEs and humanitarian device exemptions. However, the amount, kind, and quality of
evidence available to support an EUA may not always be the same as that required for treatment INDs, IDEs,
and humanitarian device exemptions under the FD&C Act and Agency regulations. If, based on the totality of
the scientific evidence available, including adequate and well-controlled clinical trials, if they are available, it is
reasonable to believe that the product may be effective for the specified use, the FDA Commissioner may
authorize its emergency use--provided that other statutory criteria (e.g., relating to the risk-benefit analysis
and alternatives) also are met.
Submission of a Request for Consideration: Section 564(c) requires that the data to support
authorization demonstrate that, based on the totality of scientific evidence available to the FDA Commissioner
(including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that the
product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or
condition. The exact type and amount of data needed to support an EUA may vary depending on the nature of
the declared emergency and the nature of the candidate product. To facilitate FDA review of such data, the
Agency recommends that a request for consideration for an EUA include a well-organized summary of the
available scientific evidence that evaluates the product's safety and effectiveness, including the adverse event
profile when used for diagnosis, treatment, or prevention of the serious or life-threatening disease or
condition, as well as data and other information on safety, effectiveness, risks and benefits, and (to the extent
available) alternatives.
I thing given how the FDA expects to receive an application, the data from the M/M is very relevant. I don't think the response is just a cold shoulder from the FDA, it is more of a add to the request with the S/C trial as you get it.
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