kmmr schreef op 14 december 2018 12:48:
Notulen van CAT inzake Kiadis:
2.2. Oral explanations
2.2.1. Viable T-cells - Orphan - EMEA/H/C/002397
Kiadis Pharma Netherlands B.V.; adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for a malignant disease
Scope: Oral Explanation held on 12.09.2018
Action: for adoption
List of Outstanding Issues adopted on 25.05.2018. List of Questions adopted on 08.09.2017.
The CAT Rapporteurs presented their assessment of the responses to the list of outstanding
issues. The BWP report was presented.
The applicant addressed the issues from the List of outstanding issues during the oral explanation.
The Rapporteurs updated their assessment report in the light of the CAT discussions and outcome. The second list of outstanding issues was adopted.
The response timetable will be agreed with the applicant. The response timetable will be included in the CAT minutes.