DokterTinus.. schreef op 15 oktober 2018 17:27:
Op de site van kiadis: Regulatory news.
Europe EMA
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.
US FDA
In 2017, the US Food and Drug Administration (FDA) granted ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) designation. Similar to a Breakthrough Therapy designation, RMAT status allows companies developing regenerative medicine therapies to interact with the FDA more frequently, and RMAT-designated products may be eligible for priority review and accelerated approval. As part of its RMAT status, Kiadis Pharma is benefitting from productive interactions with the US FDA, including a recent meeting.
Phase 3 clinical trial
The Company is on track with the ongoing Phase 3 clinical study to enroll 250 patients at leading transplant centers globally. The Company has now enrolled 22 patients and has 14 sites open in 7 countries. Kiadis Pharma expects to have over 20 sites open by the end of 2018, including several US sites. An interim analysis of the Phase 3 study is expected in the second half of 2020.
Arthur Lahr, CEO of Kiadis Pharma, commented: "We are pleased with our continued clinical and regulatory progress and remain on track for the initial commercial launch of ATIR101 in a first EU country in the second half of 2019. We are confident that we can address the remaining questions from EMA, allowing for a CHMP opinion in the first half of 2019. The FDA granting the RMAT status is a clear validation of the importance of ATIR101 and has resulted in productive interactions with the US FDA. We are very pleased with progress made in our Phase 3 clinical trial to date. We are again a step closer to bringing ATIR101 to patients."
Vind dit, als je Arthur nog moet/kan geloven, nog redelijk positief.
Inderdaad is de "verwachte" opinie van de CHMP verschoven van het laatste kwartaal 2018 naar het eerste half jaar van 2019. Nog een redelijke tijd om te overbruggen en te moeten kijken naar een saaie koers.
Toch vind ik het positief dat de vermarkting ongewijzigd is en nog gepland staat voor de 2de helft van 2019.
Zoals ik al vaker bij Kiadis heb gezien, vlak voor een emissie wordt de koers omhoog gepompt om vervolgens voor een paar euro minder een private placement emissie te doen. Hier ga ik voor uitkijken en misschien wel op inspelen. Al ben ik bang dat de CHMP wellicht eerder dan verwacht komt met hun opinie waardoor ik bang ben de boot te missen.
Ik heb ondertussen ook een flinke winst zien verdampen en sta zo ongeveer weer op gelijk...
We shall see...