bezinteergebelegt schreef op 29 mei 2020 13:21:
[...]Kiadis kwam destijds voorbeurs. Ik zeg niet dat je nu de conclusie moet trekken dat Gala dezelfde weg krijgt.
De koersreactie bij Kiadis laat zich raden bij dit bericht.
Published: 07:00 CEST 12-10-2018 /GlobeNewswire /Source: Kiadis Pharma N. V. / : KDS /ISIN: NL0011323407
Kiadis Pharma provides regulatory and clinical update on ATIR101
Potential CHMP opinion moved from Q4 2018 into H1 2019
Guidance for initial EU commercial launch in H2 2019 unchanged
FDA meeting held under RMAT status
Phase 3 study on track with over 20 open sites expected by end 2018, of which several in US
Amsterdam, The Netherlands, October 12, 2018 - Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces a regulatory and clinical update for ATIR101.
Following recent meetings of the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), Kiadis Pharma received a Day 180 second List of Outstanding Issues relating to its marketing authorization application (MAA) for ATIR101. Kiadis Pharma has completed its evaluation of these remaining Day 180 questions. Addressing the questions will require additional analyses of existing clinical data. As expected, no new experimental or new clinical data needs to be generated. EMA has accepted the Company's request for the time needed to respond to the remaining questions. As a result, the timing of the expected CHMP opinion has moved from the fourth quarter of 2018 into the first half of 2019. Following potential EU approval, which typically follows a positive CHMP Opinion within 67 days, Kiadis Pharma intends to commercially launch ATIR101 in a first EU member state in the second half of 2019, which is unchanged versus previous guidance.