Anyone ever heard of something like this from the
Post# of 153880
(Total Views: 456)
Posted On: 01/20/2021 9:45:18 AM
Anyone ever heard of something like this from the FDA ? Sure would speed up our BLA for HIV .
On January 18, 2021, Sesen Bio, Inc. (the “Company”) completed an Assessment Aid submission to the FDA in connection with the Company’s Biologics License Application (“BLA”) for VicineumTM as part of a voluntary program developed by the FDA’s Oncology Center of Excellence. Following the Company’s submission of the BLA, the Company was selected to participate in the Assessment Aid program as part of the BLA review process.
The Assessment Aid is based on the FDA Multidisciplinary Review template with the main objectives of focusing the FDA review on the benefit-risk profile, increasing efficiency to decrease review time and, should Vicineum be approved, the Assessment Aid helps support the summary basis for approval.
In addition, the Company has been invited to participate in an FDA Application Orientation Meeting (AOM) in late January 2021 in order to educate the FDA review team on the BLA submission to further facilitate the FDA’s review.
On January 18, 2021, Sesen Bio, Inc. (the “Company”) completed an Assessment Aid submission to the FDA in connection with the Company’s Biologics License Application (“BLA”) for VicineumTM as part of a voluntary program developed by the FDA’s Oncology Center of Excellence. Following the Company’s submission of the BLA, the Company was selected to participate in the Assessment Aid program as part of the BLA review process.
The Assessment Aid is based on the FDA Multidisciplinary Review template with the main objectives of focusing the FDA review on the benefit-risk profile, increasing efficiency to decrease review time and, should Vicineum be approved, the Assessment Aid helps support the summary basis for approval.
In addition, the Company has been invited to participate in an FDA Application Orientation Meeting (AOM) in late January 2021 in order to educate the FDA review team on the BLA submission to further facilitate the FDA’s review.
(2)
(0)