BLOO7 schreef op 4 oktober 2020 15:52:
31 maart 2020
Debjit Chattopadhyay -- H.C. Wainwright -- Analyst
Hey, good afternoon. Thanks for taking my questions. So I'm just curious about where you stand with the RA MANTA program and especially for any supplemental NDA for UC. Would that be necessary to file? And a follow-up on a prior question regarding the differentiated label. What kind of interactions have you had with the FDA now that there is unlikely to be an ad com to push for a label, which recognizes the PE DVT differentiation?
Walid Abi-Saab -- Chief Medical Officer
All right. So again, this is Walid. As you know, the status of the MANTA program has not been disclosed yet. The most that Gilead has shared is that we should expect to complete recruitment in the second half of this year. That would be for all the MANTA program, both MANTA in the UC population as well as the MANTA in the rheumatology MANTA-RAy. That's the name of the study.
In terms of discussion with the FDA, again, these things, we don't comment on them. There's been a number of discussions, of course, that our partner, Gilead has had with the FDA. What we say is that we're very appreciative with the work that they're doing. We're very confident in the data package that we have developed for filgotinib in RA, and we look forward to having further discussion as we get closer to the PDUFA later this year.
Regarding submission in UC and whether MANTA will be needed or not, again, I cannot comment on this, but I think it's a little premature before we even have the results of SELECTION. So I think just any discussion with the FDA will have to happen on that indication after the results of the SELECTION come out later this quarter. Thank you for your question.
Voortdurend op de hoogte dus,
maar ik kan daar geen toelichting over geven.
Zo klonk het over de eerdere discussies tussen Gilead en de FDA
Waarom kan of mag je daar geen eerlijke open toelichting over geven?
Volgens mij werd toen duidelijk al de conservatieve houding van de FDA aangevoeld,
iets wat wij als kleine belegger totaal niet konden aanvoelen.
Als je niet open kan of mag communiceren over iets, dan hapert er iets.
Wel dus.