Case Study
Objective: To collect additional data requested by the FDA to support a complete BLA data package.
What has been done:

1. The project began as a humanitarian aid program, during which 19 patients received treatment.
2. The subsequent project was conducted as a retrospective clinical trial.
3. Study startup, including feasibility assessment, took one month.
4. Obtaining IRB (LEC/EC) approvals also took one month.
5. Patient enrollment: 17 patients were enrolled within two weeks (out of the 19 who received treatment as part of the humanitarian aid program).
6. All data were collected according to the Sponsor's schedule within 1.5
months.
The collected data has been accepted by the FDA and will enable the Sponsor to proceed with the market authorization submission.
Case study 1
Duration of the whole project: 6 months
Objective: To collect additional data requested by the FDA to support a complete BLA data package.
Case study 1
Duration of the whole project: 6 months
What has been done:

1. The project began as a humanitarian aid program, during which 19 patients received treatment.
2. The subsequent project was conducted as a retrospective clinical trial.
3. Study startup, including feasibility assessment, took one month.
4. Obtaining IRB (LEC/EC) approvals also took one month.
5. Patient enrollment: 17 patients were enrolled within two weeks (out of the 19 who received treatment as part of the humanitarian aid program).
6. All data were collected according to the Sponsor's schedule within 1.5
months.
The collected data has been accepted by the FDA and will enable the Sponsor to proceed with the market authorization submission.