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My money is on the institutions.
Price is behaving exactly as you state about tutes establishing a position.
As far as revenues, Kite was given a pass on an adcomm meeting, which could mean they are approved as fast as Novartis. This would be huge.
https://endpts.com/fda-hands-kite-pharma-a-pass-on-axi-cel-panel-review-car-t-ready-to-launch/
I also expect revenue to pick up from this:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133549764
And this:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133549764
Wrong Again.
If you ever bother to read what is posted, you would see the amount from Woodford is 95 million.
More FUD spewing...
Woodford's financing's totaled 95 million...
https://www.nwbio.com/nw-bio-annouces-financings-totaling-35-million-expand-accelerate-dcvax-l-dcvax-direct-programs/
https://www.nwbio.com/nw-bio-announces-40-million-financing/
https://www.nwbio.com/nw-bio-has-entered-into-an-agreement-for-30-million-of-new-equity-funding-from-woodford-investment-management/
News today.
They are launching a refrigerated service in partnership with
Pelican Bio Thermal. Seems to be the beginning of the opening of another segment of the market to them. I find this as very good news.
https://finance.yahoo.com/news/cryoport-launches-cryoport-certified-cool-124500471.html
Cryoport Launches - Cryoport. Certified. Cool.
[PR Newswire]
PR NewswireAugust 15, 2017
Cryoport. Certified. Cool. solution is designed to provide cold-chain logistics in the 2 - 8 degrees Celsius temperature range for regenerative therapy requirements
IRVINE, Calif., Aug. 15, 2017 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX, CYRXW) ("Company"), the world's leading cryogenic logistics company dedicated to the life sciences industry, today announced it has expanded its portfolio of cold chain logistics solutions with the launch of its 'Cryoport. Certified. Cool.' solution, which will be branded as "C3 ™", in support of the new high value regenerative therapies that require temperature-controlled transportation within the 2 - 8°C temperature range during the logistics of processing these new therapies.
Cryoport, Inc.
Cryoport, Inc.
Cryoport's C3 ™ shipper offers the first 2-8°C shipping solution designed for synergistic integration into its intuitive informatics platform, the Cryoportal™ Logistics Management Platform. The C3 ™ solution provides enhanced, real-time visibility, security and risk mitigation from temperature excursions for the client's critical biological commodities. The introduction of C3 ™ means that Cryoport can support the entire logistics continuum for regenerative medicine clinical and commercial programs.
Cryoport strategically selected the well-established, validated, and reusable Credo Cube™ from Pelican BioThermal for its proven temperature protection, engineered the Smartpak II™ Condition Monitoring System, which provides real-time visibility into the location and key aspects of critical shipments and, then, seamlessly integrated the system into its Cryoportal™ Logistics Management Platform for cold chain transparency, monitoring and responsiveness. The C3 ™ solution includes Cryoport's 24/7/365 Client Support, which proactively monitors shipments and takes action to mitigate risks when they occur.
Dr. Mark Sawicki, Chief Commercial Officer of Cryoport, commented, "The C3 ™ solution was developed in response to recurring requests from our clients who wanted to be able to leverage our trusted Smartpak II™ Condition Monitoring System and our Cryoportal™ Logistics Management Platform to manage their shipments, not only for the cryogenic temperature range, but also in the 2-8°C temperature band. Our new C3 ™ shipper integrates new packaging technology and leverages our cold chain logistics expertise along with our 24/7/365 logistics and client support making Cryoport's C3 ™ solution the most reliable, groundbreaking 2 - 8°C logistics solution in the life sciences industry."
"C3 ™ is a demonstration of Cryoport's ability to scientifically-design and implement logistics solutions for the life sciences that provide steadfast protection of our clients' valuable biologic materials, including for regenerative therapies, which is our most rapidly growing market."
About Cryoport, Inc.
Cryoport is the life sciences industry's most trusted global provider of cold chain logistics solutions for temperature-sensitive life sciences commodities, serving the biopharmaceutical market with leading-edge logistics solutions for biologic materials, such as regenerative medicine, including immunotherapies, stem cells and CAR-T cells. Cryoport's solutions are used by points-of-care, CRO's, central laboratories, pharmaceutical companies, manufacturers, university researchers et al; as well as the reproductive medicine market, primarily in IVF and surrogacy; and the animal health market, primarily in the areas of vaccines and reproduction. Cryoport's proprietary Cryoport Express® Shippers, Cryoportal™ Logistics Management Platform, leading-edge SmartPak II™ Condition Monitoring System and geo-sensing technology, paired with unparalleled cold chain logistics expertise and 24/7 client support, make Cryoport the end-to-end cold chain logistics partner that the industry trusts.
Yeah, you're right. Direct is a miserable failure. Just ask Allan Butler.....
I am intrigued as to the timing of this 8-K.
On a Monday, in the middle of the trading day?
This is not the usual MO, where it is released on a Friday after market close. HMMmmmmm.
What team are you on?
There was also this from the last conference call.
https://seekingalpha.com/article/4070269-cryoports-cyrx-ceo-jerry-shelton-q1-2017-results-earnings-call-transcript?part=single
As mentioned previously, in addition to the regenerative therapy space CryoPort has been very successful in landing large pharma support projects for global biologics manufacturing. We have recently been awarded two global program support contracts from top 10 pharmas. In addition to the projects already supported. Both project wins entailed the large pharma client dissolving your own cryogenic fleet all shipping over to CryoPort. These will ramp throughout the current fiscal year. CryoPort anticipates additional program as in this space in the coming months and quarters as market awareness of CryoPorts develops.
I am wondering about the revenue from this drug with BMS.
They have been engaged with this one for over a year, and this drug was already approved and on the market. Maybe, just maybe, earnings are helped this quarter from this?
6/25/16
https://seekingalpha.com/article/3984752-cryoports-cyrx-ceo-jerry-shelton-q4-2016-results-earnings-call-transcript
Of the 13 Phase 3 programs we are heavily engaged in commercialization discussions with six companies under commercial launch needs, the earliest of which is set to launch in late fiscal year 2017 or early fiscal year 2018. In addition, we have just signed our first commercial program with one of the largest pharmaceutical companies in America supporting a $4 billion blockbuster biologic product that is already on the market.
11/13/16
https://seekingalpha.com/article/4023349-cryoports-cyrx-ceo-jerry-shelton-q2-2017-results-earnings-call-transcript?part=single
By developing relationship with Bristol-Myers Squibb, it is of particular note. BMS is pursuing multiple drug platforms in immuno-oncology and gene-therapy treatments among others, and in there is selected CryoPort to support logistics for their cryogenic component of a commercially launched therapy. This program will craze in over coming quarters as a relevant - as the relevant quality and regulatory elements are completed. To underscore the importance of BMS, in 2015, Bristol-Myers Squibb invested $4 billion in R&D, which included the discovery and development of new medicines for patients.
We are delighted to report this relationship at a time when BMS is investing significantly in developing and producing new regenerative medicines. As I reported before, as our clients progress through clinical trial phases, we are poised to experience greater shipping volumes. As a reminder, annualized revenue to CryoPort for Phase I trials typically ranges from $15,000 to $75,000 annually; for Phase II $50,000 to $150,000; for Phase III $200,000 to $1 million, and when commercialized, we anticipate $3 million to $20 million-plus annually. The sequential increases in revenue, as they materialize, will significantly accelerate our growth.
Brian Marckx
Hi guys, and congratulations on the quarter. Very nice and great progress. Jerry, just for clarity on my end, Bristol-Myers is the large pharma client that you had referenced on prior calls. Is that right?
Jerry Shelton
Yes, that's correct. Yes.
Brian Marckx
Okay. So I didn't catch all of your comments regarding that, and I apologize. But wondering if you could just go through again what your relationship is in terms of that, and then, when you think that that will start generating revenue?
Jerry Shelton
Mark, I'm going to turn that question to you.
Mark Sawicki
Sure, happy to answer that. So what we’re seeing is we've been asked to support the cryogenic component of one of their biologic blockbuster drugs. But the exact timing of the ramp-up of that support is going to be heavily dependent on us going through their regulatory and quality approval processes. Ultimately there will be - the ramp rate will be dictated by the progress and the expediency that we can move through those processes themselves.
We are actively supporting certain aspects of the program, but it will ramp and additional components will be added as we clear these quality and regulatory hurdles.
Brian Marckx
Mark, when you talk regulatory, is it already FDA-approved?
Mark Sawicki
This product is, but any time you change any support element of an approved or a clinical program, you have to do, what is known as, a bridging study. And in that bridging study, you have to validate that any change in protocols and that support have to be consistent. And so they have to conduct those types of elements to assuage the regulatory authorities.
Brian Marckx
Okay. So you will be - CryoPort will be involved in the shipping of the product to - from where to where? Can you just help me with that?
Mark Sawicki
I can't tell you more than that at the moment. Sufficed to say, as I had mentioned, we are supporting the cryogenic component of it.
Brian Marckx
Okay.
Mark Sawicki
But I haven't been given authority to disclose anything more than that from them at the moment.
As Constitution said, I think any suitor would be a company like Amerisource Bergen, not one of the big 3.
I am a shareholder of Cryoport. I owned warrants that I received in an offering I participated in. The warrants were originally $3.57, and the company, after shareholder approval, allowed you to exercise these warrants at $1.50, and for every 4 you exercised, you got another warrant at $3.00. So, it would seem, there is some leeway here.
https://www.sec.gov/Archives/edgar/data/1124524/000114420416121858/v448019_sctoia.htm
I think you are looking at an old edition. It is issue 20, not the July 20 edition. It was published July 10, 2017.
Volume 35, Issue 20, July 2017
If you look at the link below, you will see there is another issue due in July. Will NWBO be in there. Maybe, maybe not, but we do not know yet.
http://ascopubs.org/loi/jco
I agree the next issue is out on July 20th, which is 6 days.
When do you think they start putting it together, on July 19th?
I am good with that scenario, except I would PR Monday morning.
But Linda has her own way of doing things.
I do not discount this theory. But I have another one to throw out to muddy the waters. I am in the camp of the peer reviewed article.
It has been mentioned by some, that this article is imminent. It has also been mentioned that it will be in the Journal of Clinical Oncology. Their next issue, it is said, ships out on Sunday night, so it must have printed this week sometime. I surmise, this could be leakage about the article. A lot of eyes have seen it by now.
I guess this guess is as good as the next.
I believe Cryoport ships for Northwest.
Linda thnks the shippers are the greatest thing ever.
I remember her gushing about how you could forget about it on the receiving dock for a few days with no problem.
Also, she said the containers looked like R2D2.
So far, So good....
http://www.reuters.com/article/us-novartis-cancer-idUSKBN19X2OZ?il=0
#Business News
July 12, 2017 / 3:31 PM
FDA panel backs Novartis' pioneering new cancer gene therapy
(Reuters) - Novartis AG's (NOVN.S) pioneering new cancer drug won enthusiastic support from a federal advisory panel on Wednesday, paving the way for approval of the first U.S. gene therapy.
The panel unanimously recommended that the Food and Drug Administration approve the drug, tisagenlecleucel, for patients ages 3 to 25 with relapsed B-cell acute lymphoblastic leukemia (ALL), the most common form of U.S childhood cancer.
The drug uses a new technology known as CAR-T, or chimeric antigen receptor T-cell therapy, which harnesses the body's own immune cells to recognize and attack malignant cells.
In a clinical trial, 83 percent of patients who had relapsed or failed chemotherapy achieved complete or partial remission three months post infusion. After one year 79 percent of patients were still alive.
Patients with ALL who fail chemotherapy typically have only a 16 percent to 30 percent chance of survival.
"This is a potentially paradigm-changing type of benefit," said Dr. Brian Rini, a panelist and physician at Cleveland Clinic Taussig Cancer Institute.
The FDA is not obliged to follow the recommendations of its advisers but typically does so. The agency is expected to rule on the drug by the end of September.
Approval of tisagenlecleucel would have significant implications not only for Novartis but for companies developing similar treatments, including Kite Pharma Inc (KITE.O), Juno Therapeutics Inc (JUNO.O) and bluebird bio Inc (BLUE.O).
It would also advance a technique scientists have been attempting to perfect for decades and help lift the entire field of cell therapy.
"This will be a historic approval," said Brad Loncar, chief executive of Loncar Investments which runs the Loncar Cancer Immunotherapy ETF (CNCR.O). "As an investor I've never seen anything like it. It's an entirely new way of treating cancer."
The product is made by extracting and isolating a patient's T cells, genetically engineering them to recognize and target cancer cells, and then infusing them back into the patient. Novartis said the entire process will take 22 days by the time it is launched.
The treatments are given just once and are expected to cost up to $500,000. Loncar said approval of tisagenlecleucel would represent an inflection point for investors.
"Any time a new technology crosses the finish line at the FDA, it gets noticed and I think you'll see a rush of investment and see these therapies be improved over time."
More than half of patients experienced a serious complication known as cytokine release syndrome (CRS) which occurs when the body's immune system goes into overdrive. Doctors were able to manage the condition and the syndrome caused no deaths.
The FDA expressed concern that the drug could cause new malignancies over the long term. Panelists generally felt that risk was low and they said Novartis's risk mitigation proposals were adequate.
Novartis is also testing the drug in diffuse large B-cell Lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma, as is Kite.
Novartis's stock (NVS.N) closed up 1.5 percent at $83.21 in U.S. trading. The shares (NOVN.S) finished up 2.2 percent at 80.5 Swiss francs in Zurich before the vote was taken.
I am under the impression that the only warrants that are now callable are the free ones given in the last rights offering. I understand the warrants from the preferred stock offering are not callable.
Did you participate in the rights offering, exercise your warrants for $1.50, and get free warrants that are now callable?
Thanks in advance.
I am innocent...LOLOL
I did find this, so they do cryo shipping. There has to be a reason that all these trials are choosing CRYX. Maybe it is price, or the service itself.
http://www.icsconnect.com/integrated-logistics/product-storage-and-distribution
Do not have access to the report. Just saw they had raised the target price.
Nice, but long article on the importance of logistics in the commercialization of cell based biologics. I had to read it twice for it to sink in. Sheds new light on the challenges that arise in the manufacture and delivery of these new therapies.
Because autologous therapies are comprised of living cells with a limited lifespan, logistics expertise will be incredibly important to coordinate and connect services that are designed as a unique program - tailored to perfectly sync with the apheresis center, provider, manufacturer and patient for each cell therapy. Some of the many services that a manufacturer may require include: the fulfillment of kitting at apheresis site, the coordination and tracking of shipments, temperature monitoring and real-time temperature tracking, notification of interruptions or changes, chain of custody tracking, product data monitoring, and advanced cryopreservation and cryoshipping technologies that add an element of flexibility in the supply chain. Manufacturers should also ask logistics partners about their experience with contingency planning to assess their capability to resolving a variety of unexpected situations.
https://www.dddmag.com/article/2017/06/new-challenges-redefine-complexity-commercialization
Needham raised their price target to 6 dollars today.
Also, July12th is just around the corner...
July 12 FDA panel review looms as a watershed moment in Novartis’ campaign to win an historic new drug OK
http://www.prnewswire.com/news-releases/novartis-pivotal-ctl019-6-month-follow-up-data-show-durable-remission-rates-in-children-young-adults-with-rr-b-cell-all-300478830.html
I wasn't thinking in terms of a buyout, although I agree with you it would be one of the big 3 shippers if it were to happen somewhere down the road. My thinking was the Streetsweeper is wrong again. Shorts play funny games when the tide is turning against them.
The StreetSweeper...
This is the same RAG that put out this on Celator Pharmaceuticals (CPXX) on 2/29/16 when the stock was trading below 2 dollars. On 3/14/16, the company released positive phase 3 data which propelled the stock into the teens on its way to being bought out by Jazz Pharma just just 3 months later for $30 a share.
https://www.thestreetsweeper.org/undersurveillance/Celator_Pharmaceuticals__Eight_Key_Risks_Threaten_To_Chop_This_Stock
Big, no Huge Yawn.
I would sure like to know how many shares are now out on this PIG.
If someone knows, include the preferred shares also. I know Kirk has over 20 million of those. I assume the total is close to 40 million.
What a screw job. GOOD RIDDANCE to that loser Kinnon.
I will follow him wherever he goes and warn everyone he is there.
What a POS!
Interesting article on manufacturing. This is only a teaser as this is a pay site. If anyone has a subscription maybe they can give a summary. May give some answers to some of our manufacturing questions.
https://www.statnews.com/2017/06/09/car-t-challenges/?s_campaign=endpts
News....
https://finance.yahoo.com/news/cryoport-expands-agreement-sanaria-support-123000114.html
Cryoport Expands Agreement with Sanaria to Support Grant Awards with U.S. National Institutes of Health and U.S. Army
[PR Newswire]
PR NewswireJune 7, 2017
IRVINE, Calif., June 7, 2017 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX, CYRXW), the world's leading cryogenic logistics company dedicated to the life sciences industry, announces that it will assist Sanaria Inc. in the design and implementation of the cryogenic cold chain for Sanaria's investigational malaria vaccines. This work is supported by grants to Sanaria from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) (phase II Commercialization Readiness Pilot Program) and U.S. Department of Defense (DoD) (phase I Small Business Innovation Research).
Cryoport, Inc.
Cryoport, Inc.
Cryoport's expertise in cryogenic logistics will be applied to distribution models for Sanaria® PfSPZ Vaccine for travel clinics (NIAID, NIH grant) and the U.S. military (DoD grant). This work will assist in the implementation of Phase 3 clinical trials of the vaccine and the development of cryogenic logistics distribution in support of the anticipated commercial launch of PfSPZ Vaccine, which is cryopreserved. Initially, vaccine distribution will be aimed at filling the needs of the U.S. DoD, State Department, and Peace Corps, travel medicine companies, and extraction industries. The Cryoport designs will incorporate distribution models enabling "just in time" delivery by providing logistics support incorporating novel packaging designs, inventory management, liquid nitrogen (LN2) replenishment and will test transport to specific clinics. Cryoport's SmartPak II monitoring system will be utilized to manage in real time the "chain of custody" distribution logistics as well as the "chain of condition" environmental conditions. The SmartPak II works alongside Cryoport's Cryoportal™ software system to provide comprehensive logistics monitoring, including GPS tracking, which locates dry shippers and payloads and proactively tracks potential adverse events which may occur due to weather, logistics handling, or other delays.
Jerrell Shelton, Chief Executive Officer of Cryoport, commented, "We are thrilled to have been selected to develop models for the distribution of Sanaria's groundbreaking malaria vaccine as part of these two projects. This selection, we believe, is a testament to the quality and reliability of our cryogenic logistics solutions. We are proud to support Sanaria's work developing and eventually bringing to market a vaccine to prevent malaria."
Dr. Stephen L. Hoffman, Chief Executive and Scientific Officer of Sanaria stated, "Cryoport's expertise in cryogenic logistics management, track record and reputation were important in helping to secure funding from the U.S. DoD and NIAID, NIH. Cryoport has reliably supported our research efforts over the past five years and they were the natural partner for these new projects."
Sanaria's malaria vaccines have achieved more than 90% protection in multiple clinical trials to date. Current clinical studies aim to finalize the regimen (dose strength, number of doses, and interval between doses) for the traveler's indication. Future Phase 3 clinical trials are intended to lead to licensure of the vaccine for prevention of malaria in travelers and subsequently for use in mass vaccination programs in the countries most affected by malaria.
Maybe even Higher....
Another Cryoport customer......
http://investor.bluebirdbio.com/phoenix.zhtml?c=251820&p=irol-newsArticle&ID=2278711
Maybe they should have gone higher than that:
July 12 FDA panel review looms as a watershed moment in Novartis’ campaign to win an historic new drug OK
by John Carroll — on June 6, 2017 10:20 AM EDT
If you have any interest in the CAR-T field, mark down Wednesday, July 12 as a red letter day.
The FDA posted a note on Tuesday saying that its group of outside cancer experts will gather that day to discuss the pharma giant’s application and vote on whether Novartis $NVS should get a marketing approval for its leading CAR-T CTL019 (tisagenlecleucel-T) as a new treatment for relapsed and refractory pediatric B-cell acute lymphoblastic leukemia. And on Monday preceding the panel review the FDA will be expected to deliver its internal review of the therapy, which will further tip its hand on what regulators are thinking about the data for a drug awarded its breakthrough therapy designation.
The latest twist in this closely-watched saga comes a little more than two months since Novartis won a priority review for its potentially revolutionary CAR-T, which extracts T cells from patients, reengineers them and infuses them by the millions to swarm cancer cells. The priority review lopped two months off the review process, hitting fast forward on the agency’s call.
Right on its heels, two months behind in the process, is Kite Pharma $KITE with its application to market KTE-C19 (axicabtagene ciloleucel) for non-Hodgkin lymphoma, also newly offered a priority review of its own.
Novartis and Kite have both offered some compelling data for these CAR-Ts. And while they are not currently going head-to-head on the same indication, Novartis will be offering what could be a direct challenge when it rolls out its JULIET data mid-week.
I’ll be following that too.
In addition to efficacy, you can expect plenty of discussion about the safety profile of this drug. Unlike its rivals, Novartis and its partners at the University of Pennsylvania have largely avoided the safety crises that afflicted Juno $JUNO and blew up its lead therapy. Kite also has had to deal with the death of one patient from a case of cerebral edema while cytokine release syndrome continues to hover as clear threat that physicians have to guard against in many cases.
If approved, Novartis will also be expected to compete effectively on the manufacturing side, working to reduce the time it takes to get this drug from patients, prepare it and then get it back into the vein.
Maybe they are trying to tell us something.
Have never seen this before, kinda interesting that they did it.
Maybe this has something to do with it!
CHICAGO — With its lead program for non-Hodgkin lymphoma in front of FDA reviewers, Kite Pharma $KITE today updated their Phase I CAR-T study on relapsed cases of acute lymphoblastic leukemia, noting a strikingly high complete remission rate of 73% as they continue to work on improving the safety profile of their therapy.
The study included 11 patients in the Phase I portion of ZUMA-3. Complete remissions — with the responders all testing negative for minimal residual disease with few or no cancer cells in circulation — were being tracked that lasted from 2 to more than 7.4 months. And the Phase II trial will get underway as Kite looks to expand use of its drug KTE-C19.
David Chang, Kite
“In many ways it sort of confirms what we thought we’d see in the clinical study; very rapid response in 2 to 4 weeks,” Kite CMO David Chang tells me.
Safety, though, remains a key concern. These CAR-T studies have been marred from the beginning by common cases of cytokine release syndrome. In this trial, there were three cases of grade three or higher CRS with one death and six cases of grade three or higher neurological reactions.
That left Kite looking at who should receive tocilizumab within 36 hours post-KTE-C19 infusion, and a lower dose of 0.5×10(6) CAR T cells/kg rather than the two doses of 2.0×10(6)/kg and 1.0×10(6)/kg used in the first round.
Kite recently reported that one patient died recently from cerebral edema, or brain swelling, in a separate trial, rattling investors who didn’t like the comparisons to the five cases of cerebral edema that forced Juno to scrap their led program, leaving Kite and Novartis alone in the race to a potential first approval later this year.
Kite has learned a lot about controlling safety, says Chang. Dosing, getting rid of infections before treatment, preparing to battle back CRS are all part of the game plan now.
Cases of cerebral edema have also sparked a debate over whether the CD28 costimulatory domain Kite uses in their CAR-Ts — instead of the 4-1BB domain Novartis uses — could be responsible. Juno’s initial lead therapy also used the CD28 costimulatory domain.
“In a way I can see why some people would say that, but there’s really no basis to draw that conclusion,” says Chang. He adds that there have been cases of cerebral edema with 4-1BB going back to the early academic studies.
Chang also isn’t keen on making cross-trial comparisons.
“There’s a lot of false conclusions that one can draw,” he says. But outcomes can be altered by the characteristics of the patients recruited, whether they were truly chemo refractory or simply relapsed, how many times they had relapsed on multiple lines of therapy and the distribution of disease types, all of which play into the data.
Kite has also been honing its manufacturing skills. In this latest Phase I the manufacturing team was able to get the time it takes to make the therapy from patient cells down to six days. Chang says that the company has the vein-to-vein time down to about 17 days, which he believes can still likely be improved by two or three days.
https://endpts.com/with-one-bla-at-the-fda-kite-hustles-along-impressive-new-leukemia-data-and-sounds-a-note-of-caution-on-safety/?utm_medium=email&utm_campaign=236%20Monday%206517&utm_content=236%20Monday%206517+CID_8862f9003164cdc1c46f8fa8eaf893a6&utm_source=ENDPOINTS%20emails&utm_term=With%20one%20BLA%20at%20the%20FDA%20Kite%20hustles%20along%20impressive%20new%20leukemia%20data%20and%20sounds%20a%20note%20of%20caution%20on%20safety
Outstanding work Senti, Thank You!