Im just adding a heads up to my previous post about upcoming BLA submission!
$Atara Biotherapeutics(ATRA.US$ PAY VERY CLOSE ATTENTION TO THE LAST 3 BULLET POINTS! This could be a catalyst for a large price increase? Even if its only a temporary increase? I want you to have ample opportunity to catch ahead of time if YOU CHOOSE? Not me choosing for YOU! NFA! Just a heads up for the possibility! Tab-cel U.S. BLA on Track for Submission in Q2 2024 Following Positive Pre-BLA Meeting! key upcoming milestones for 2024. Atara’s focused on submitting the BLA for tab-cel in the second quarter, the progress of which triggers financial milestones and sales royalty opportunities in our partnership with Pierre Fabre.” Tabelecleucel (tab-cel® or EbvalloTM) for Post-Transplant Lymphoproliferative Disease (PTLD) • Atara recently held a positive pre-BLA meeting with the U.S. Food and Drug Administration (FDA) that supports its plan to submit the tab-cel relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) Biologics License Application (BLA) in Q2 2024. • Data from the pivotal Phase 3 ALLELE study of tab-cel were published in The Lancet Oncology and showed a significant 51.2% objective response rate (ORR) and 23.0-month median duration of response in relapsed or refractory EBV+ PTLD subjects. Tab-cel was well tolerated with no events of graft-versus-host disease related to tab-cel. • Positive new data presented at the 2023 ESMO-IO meeting from the actively enrolling, multicohort Phase 2 EBVision trial with a pooled analysis demonstrated a 77.8% ORR in 18 central nervous system (CNS) EBV+ PTLD subjects including front line EBV+ PTLD. • Atara and Pierre Fabre Laboratories closed the expanded global partnership in December 2023 for the development, manufacturing, and commercialization rights of tab-cel in the United States and all remaining markets • Atara received approximately $27 million in cash upfront at the closing of the deal. Under the agreement, Atara has the potential to receive up to $640 million in additional payments and significant double-digit tiered royalties on net sales, including up to $100 million in potential regulatory milestones through BLA approval • Atara expects to receive $20 million of these regulatory milestones in April based on the recent positive pre-BLA meeting, another $20 million in connection with BLA acceptance, and the remaining $60 million in potential regulatory milestones in connection with BLA approval • In addition, Pierre Fabre Laboratories will reimburse Atara for tab-cel regulatory and development costs through BLA approval, and purchase tab-cel inventory manufactured through BLA transfer
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Benjamin’s : This for tomorrow or just reminder,? I didn’t see date.? TIA
TrytosaveabitOP Benjamin’s: It could move tomorrow? But it’s for a later date! They said April to sometime Q2! But that’s why I put it out now! GL
Jaguar8 : Very important drug. EBV virus unknowingly to most humans, it is 90% of population affected worldwide
TrytosaveabitOP Jaguar8: Dead on accurate as I’ve come to expect from you!
Jaguar8 TrytosaveabitOP:
You know we both love these clinical studies
TrytosaveabitOP Jaguar8: True dat!
BeeDeeVee712 TrytosaveabitOP: I know I've been MIA recently but you can add me to your group of people in love with clinical studies, great chances for growth potential if you know how to read and understand the studies and have a decent understanding of the medical field (or better yet, some one else who really understands that field better than i do
TrytosaveabitOP BeeDeeVee712: Whether you are here daily or have to be away for days,weeks at a time. You little gal, especially with being a TIDE fan ( now that Nick’s gone we gotta support each other ) hehehe! Are already added and you have been for a couple months! Hehehe! Hope things have been going good with you.
BeeDeeVee712 TrytosaveabitOP: Same, hope things have been going well with you too! I just got a bit burnt out from doing daily analysis on the side and took a week or 2 to decompress and am ready to comeback with a vengeance! And yeah, seriously, with Saban gone I'm interested to see what this new era will look like, but it's been a bit worrisome to see the amount of players enter the transfer portal, this will be an intriguing first non-Saban season. P. S. I can't remember I told you this or not prior but Saban is the reason I'm an Alabama fan, it wasn't vice-versa. I loved his coaching philosophy and after he left LSU (who can suck it big time lol) and did his first interview at Bama I was hooked (plus at that time my college football team couldn't beat a high school football team and I'm a hardcore sports fan so I needed something real to root for!! I definitely backed the right horse in that decision!
TrytosaveabitOP BeeDeeVee712: Nice to see you back! Yup everyone needs a break once in a while!
I’ve been a BAMA fan most of my life. Even back in early 90’s when they were suspended from playing bowl games for players having great paying jobs but mysteriously never showed up to work! Hehehe! Yes when Nick left LSU I was ecstatic because I have been a Dolphins fan just as long! Now he was my Pro coach! And since I like college football more! In 2007 his debut in Tuscaloosa, well I don’t think I could have been anymore excited to see if he would end up as great a coach as Bear Bryant? Hehehe I was not disappointed!
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