RE:RE:RE:Une question!!I forgot to highlight that Fred wrote "commercialisation" and not "approval" (as was posted) H2 2019
1- Ryplazim: True that we have not yet submitted and filed the amendments. Until we have done so we won’t know the new PDUFA date. Given where we are at right now, we are indeed most likely looking at commercialisation during the second half of 2019. Don’t ask me if it will be July 1 or November 1. I don’t know. Once we will have the new PDUFA date, we’ll have a much better idea. Before we get there, we need to run the new conformance plasminogen batches, send them to the fill&finish external supplier. Get everything analyzed, prepare the regulatory dossier, refile the documents etc…A lot of work that will need to be done and then we get the FDA to provide us with a new date. So I can’t provide exact timelines for a while still but we are indeed most likely looking at commercialization in H2 2019.