Wall Street Trader schreef op 10 september 2019 14:50:
We clarified with Galapagos that the FDA had access to the MANTA data generated to date and
Galapagos confirmed this, and
also that the agency appears to be being more flexible with the filing of an NDA ahead of the full MANTA readout.
This is terrific news because Gilead has a priority review voucher, and if Gilead chooses to use the voucher, the implication is that filgotinib could be approved by mid-2020 in the U.S.See for more information regarding priority review vouchers;
priorityreviewvoucher.org/Gilead’s Chairman and Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley Global Healthcare Conference in New York on Tuesday, September 10 at 10:00 a.m. Eastern Time.The audio portion of the fireside chat will be accessible live through the company’s Investors page at
investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast.
The replay will be available for 14 days following the presentation.