Investor68 schreef op 15 oktober 2018 13:45:
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You said: "Het gaat hier gewoon over een nieuwe statistische analyse van de beschikbare data van het fase-2 onderzoek." My question to you is this: Is it not possible that the new statistical analysis could lead to a rejection of the application for approval of ATIR101? Is it not possible that based on the new statistical analysis, the CHMP or EMA could conclude that the number of patients (15) that were used for the phase two clinical trials were too small? In fact, the EMA might decide to wait for the results of the ongoing phase three trials before ruling on the application for approval of ATIR101. All these scenarios are possible. Because we do not know what the new questions are and the answers Kiadis will provide to CHMP, we cannot tell with certainty how long the whole process will take. There is simply not visibility now!
You also said:"De vertraging heeft ook te maken met de verhuis van de EMA van Londen naar Amsterdam, waardoor er nog geen vergaderingen gepland zijn in Q1 2019."
Since the Brexit referendum more than one year ago, we all knew that the EMA will move from London to Amsterdam. Didn't the CEO of Kiadis know that the EMA will move from London to Amsterdam when he told investors on 31 August, 2018: Arthur Lahr, CEO of Kiadis Pharma, commented: “We have made tremendous progress in the last six months: ATIR101 is now very close to potential CHMP opinion in 2018..... Kiadis is in great shape and well positioned to deliver on the promise of ATIR101.”
"Day 180 List of Issues received in May 2018 and responses submitted in August 2018; On track to obtain CHMP opinion from the European Medicines Agency in the fourth quarter of 2018."
Do you really want us to believe that when the CEO made all these statements less than two months ago, he did not know that the EMA is moving to Amsterdam and that this will create delays for Kiadis?