Sesen Bio Inc (NASDAQ: SESN), a clinical firm, is developing fusion protein therapeutics for cancer patients’ treatments. The firm contributed with a US Food and Drug Administration in an effective Late-Cycle Meeting on July 13, 2021, regarding the firm’s Biologics License Application for Vicineum to treat BCG unresponsive nonmuscle invasive bladder cancer under Priority Review.
The Late-Cycle Meeting in between FDA review team members and the applicant to communicate delivers the review status under the BLA review method.
- The FDA and the firm discussed product quality data, manufacturing capacities inspection, and more information related to chemistry, controls, and manufacturing. They conceded upon a timeline for benefiting information to be submitted.
- There are No Discipline Review letters issued to date.
- The FDA does not yet confirm the Advisory Committee meeting.
- There are no issues in risk management that have been observed to date.
- There is no identification of post-marketing requirements along with a confirmatory trial.
Moreover, the review of the BLA is lasting, and the firm believes the BLA stays on track for a perceived regulatory decision by August 18, 2021.
Sesen Bio’ President and CEO Dr. Thomas Cannell said that they are delighted with the outcome of the Late-Cycle Meeting and proceed to believe encouraged by the phase of engagement from the FDA in their ongoing conversation heeding the BLA for Vicineum.
It also adds that they understand the FDA’s responsibility for reviewing items and predict a successful determination of these matters previous to the target PDUFA date.
COVID-19 Potential Impact
Sesen Bio proceeds to regulate the quickly developing environment heeding the potential consequence of the COVID-19 epidemic on their firm. The firm has not yet trained any disturbances to their operations as an outcome of COVID-19. Still, they cannot quantify or indicate with promising the scope of potential effects to their business. However, not limited to their ability to raise capital, and if approved, commercialize Vicineum. Sesen Bio persists dedicated to the health and security of the patients and employees.