Residual Risk Assessment Template Five Top Risks Of Residual Risk Assessment Template

Image source: The Motley Fool.



residual risk assessment template
 Risk assessment form - - residual risk assessment template

Risk assessment form – – residual risk assessment template | residual risk assessment template

TG Therapeutics Inc (NASDAQ:TGTX)
Q3 2019 Balance Call
Nov 12, 2019, 8:30 a.m. ET

Operator



Greetings. Acceptable to TG Therapeutics Third Division 2019 Banking After-effects and Business Amend Call. [Operator Instructions]. And a abrupt question-and-answer affair will chase the academic presentation.



[Operator Instructions]

At this time, I will about-face the alarm over to Jenna Bosco. Jenna, you may now begin.

Jenna Bosco — Senior Vice President, Corporate Communications

Thank you. Acceptable morning and acceptable to our appointment alarm apropos TG Therapeutics’ third division 2019 banking after-effects and business update. I am Jenna Bosco, TG’s Senior Vice President of Corporate Communications, and I acceptable you to our appointment alarm today.

Following our Safe Harbor statement, Sean Power, TG’s Chief Banking Officer, will accommodate a abrupt overview of our banking after-effects and afresh about-face the alarm over to Michael Weiss, the Company’s Executive Chairman and Chief Executive Officer who will accommodate an amend on the advancing development of our advance compounds, ublituximab and umbralisib, as able-bodied as an overview of our all-embracing aggregation standing.

Before we begin, I would like to admonish anybody that abounding animadversion we accomplish about our approaching expectations, plans, and affairs aggregate advanced statements for purposes of the Safe Harbor accoutrement beneath the Private Securities Litigation Reform Act of 1995. TG cautions that these advanced statements are accountable to risks and uncertainties that may account our absolute after-effects to alter materially from those indicated. Factors that may affect TG Therapeutics’ operations accommodate assorted accident factors that can be activate in our SEC filings. This appointment alarm is actuality recorded for audio rebroadcast on TG’s website, Media breadth it will be accessible for the abutting 30 days. All participants on this alarm will be on a listen-only mode.

Now I would like to about-face the alarm over to Sean Power, our Chief Banking Officer, to briefly altercate the banking after-effects for the third division of 2019 as able-bodied as Che company’s all-embracing banking condition.

Sean A. Power — Chief Banking Officer

Thank you, Jenna. And acknowledgment anybody for abutting us. As I’m abiding you’ve all now seen, our banking after-effects were arise this morning and can be beheld on the Investors & Media breadth of our website. Our net accident for the third division of 2019, excluding non-cash items, was about $59.9 million, with a GAAP net accident for this division of $61.9 million, or $0.69 per share, compared to a net accident of $34 actor or $0.43 per allotment during the commensurable division in 2018. Included in this quarter’s net accident was an access in accomplishment and CMC costs of about $27 million. These costs chronicle primarily to accomplishment costs associated with Phase 3 development and in alertness for commercialization. And we’ve been able to defended favorable acquittal agreement on the bolus of these expenses, deferring acquittal of these costs for up to one year.

Offsetting increases in accomplishment costs has been the connected abatement in analytic balloon expenses, $3.8 actor in the quarter, which we apprehend will abide into 2020. All in all, for the quarter, we saw a banknote bake of about $33 million. With the aggregate of our accomplishment costs now abaft us and with our analytic costs continuing to decrease, we apprehend our banknote bake to be in the $25 actor to $30 actor per division range. Accordingly, with a pro forma banknote position as of September 30th of about $96 million, which includes about $24 actor aloft beneath our ATM ability consecutive to the end of the quarter, and our approaching availability beneath the ATM we accept our banknote will be acceptable to armamentarium our operations into the fourth division of 2020, and importantly, through our near-term milestones of Phase 3 readouts for UNITY-CLL and MS, which we I accept should be cogent value-creating articulation credibility for the Company.

With that, I will now about-face the alarm over to Mike Weiss, our Executive Chairman and CEO.

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Great. Thanks, Sean, and acknowledge you, Jenna, and acknowledgment anybody for abutting us this morning. Seeing as we were aloof on a alarm a few weeks ago, we’re action to try to accumulate this one about short. I anticipation I’d alpha off by absorption on the ASH abstracts that were arise aftermost week, I’ll accommodate a little bit of blush and ambience about those presentations, and afresh blow on some of this year’s above accomplishments and accomplish afterwards the Q&A with some accessible goals and catalysts for the Company.

So to start, let’s allocution about the two presentations at ASH that we arise aftermost week. Aboriginal is an articulate presentation on the amateur aggregate of umbralisib, our PI3K basin and CK1-epsilon inhibitor, and ublituximab, our glycoengineered anti-CD20 monoclonal antibody, which calm we accredit to as U2. So U2 added venetoclax in patients with relapsed or adverse abiding lymphocytic leukemia, additionally CLL. This is a Phase 1/2 abstraction was advised with the absorbed to appraise whether U2 added venetoclax could potentially drive abysmal and abiding responses in a anchored timeframe of treatment. For example, in this study, 12 months and afresh stop assay if you accomplish MRD abrogating in the cartilage marrow.

A few agitative and absorbing tidbits in this abstruse included that U2 abandoned was awful alive with an all-embracing acknowledgment bulk of 85%, 11 of 13 patients, afterwards three cycles of therapy, and this is afresh above-mentioned to the accession of venetoclax. We alpha with a U2 abandoned induction, and these are patients who were heavily pretreated, relapsed/refractory CLL patients, including a cardinal of whom that were adverse to ibrutinib. Afterward aeon three, venetoclax was alien to the abstraction and all nine patients that had at atomic seven cycles of chase up at the time of the ASH abstruse acquiescence had a complete or fractional acknowledgment to the three-drug combination. As importantly, of the bristles patients with 12 cycles of aftereffect at the time of the ASH abstruse submission, all of them had able ephemeral basal balance ache in the borderline claret and four or bristles of those patients had able ephemeral MRD in the cartilage bottom and were able to stop assay at the end of aeon 12.

While these are baby accommodating numbers, these after-effects arise to represent a abundant advance over absolute therapy. We attending advanced to the presentation of added abstracts from this abstraction at ASH, including added patients through the best — and patients through best chase up to affirm these affecting effects. This abstracts will be presented at ASH by Dr. Paul Barr, Director of the Analytic Balloon Center at Wilmot Cancer Institute at the University of Rochester.

Additionally, we accept already amorphous enrolling in what we achievement will be a registration-directed Phase 2 single-arm abstraction alleged the ULTRA-V study, which looks at the aggregate of U2 added venetoclax in both relapsed adverse and treatment-naive CLL patients. This abstraction is actuality led by Dr. Richard Furman. He is the Director of the CLL Research Center at Weill Cornell Medicine actuality in New York City.

The added abstruse accustomed for a affiche presentation is the Phase 1 abstraction of TG-1701, our atypical BTK inhibitor, as a distinct abettor and in aggregate with U2 for patients with a array of relapsed/refractory B-cell malignancies. As you may recall, we accept advanced advised the amateur aggregate of U2 added a ibrutinib breadth we accustomed a 100% acknowledgment bulk in patients with CLL and bordering breadth lymphoma, with a well-tolerated assurance profile. The able after-effects apparent in the U2 added ibrutinib study, which was appear in Lancet Haematology motivated us to move our proprietary once-daily BTK inhibitor into amateur aggregate studies as rapidly as possible. The ASH abstruse includes the first-ever analytic abstracts on our BTK inhibitor, TG-1701, and includes abstracts from the single-agent accomplice as able-bodied as the amateur aggregate accomplice with U2.

Responses accept been apparent at all dosage levels and all patients advised in the amateur aggregate at the everyman dosage accept able a acknowledgment at the aboriginal assessment, including a complete acknowledgment in a accommodating with follicular lymphoma and two fractional responses, one in a accommodating with follicular lymphoma and one in a accommodating with bordering breadth lymphoma. This abstraction is decidedly important to us at TG as it represents a cogent footfall advanced in our mission to advance atypical aggregate therapies to those patients in need. This is the aboriginal amateur aggregate abstraction conducted breadth all the agents are proprietary TG biologic candidates.

Needless to say, we are aflame for the ASH affair in Orlando abutting month. Both of these trials will appear into bigger focus aback we accept the UNITY-CLL cardinal data. But amuse accept that we are administering today, the studies that will hopefully accredit a action that puts U2 in a position to use both as U2 abandoned and additionally on top of BTKs and venetoclax to optimize those treatments. Neither BTKs nor venetoclax abandoned are the solution. Our acceptance is that U2 makes these treatments bigger and should enhance the cardinal of patients that get abiding abiding remissions, so patients can stop therapy. That is the ambition of all this work.

With that, it’s apparently a acceptable time to alteration to the UNITY-CLL study, as abundant of the action of these two abstracts hinges on a absolute UNITY-CLL outcome. As a reminder, the UNITY-CLL balloon is a randomized Phase 3 abstraction of U2 compared to an alive ascendancy arm of a aggregate of a chemotherapy and an anti-CD20 monoclonal antibiotic in patients with both treatment-naive, as able-bodied as relapsed adverse abiding lymphocytic leukemia. The primary endpoint for this balloon is progression-free survival. As we’ve said previously, we achievement to accept after-effects from this abstraction about anniversary or into the aboriginal division of abutting year. However, as this is an event-driven trial, it is arduous to absolutely adumbrate the timing of completion. We abide acutely optimistic about the abstraction and the affairs for a acknowledged PFS outcome.

Before I alteration to a quick highlight-reel of what we’ve able this year so far, let me additionally admonish anybody that in accession to the UNITY-CLL Phase 3 data, we accept addition ample Phase 3 affairs account out in 2020. That, of course, is our ULTIMATE 1 and 2 Phase 3 trials in relapsing forms of assorted sclerosis. These are two absolute Phase 3 trials comparing ublituximab to articulate teriflunomide. The primary endpoint for anniversary abstraction is annualized backsliding rate, afterward 96 weeks of assay and advised to abutment acquiescence for abounding approval of ublituximab in relapsing forms of MS.

These trials are actuality conducted beneath Special Protocol Appraisal with the FDA and accept been absolutely enrolled for over a year now. We are targeting top band abstracts from these trials in the average to added bisected of abutting year. For sure, agitative times advanced for TG, but let’s not forget, all the advance we’ve fabricated already this year.

Let me accomplishment my able animadversion with a little epitomize of the — with the above achievements for the aboriginal three abode of 2019. Aboriginal in the year, we arise that our allotment directed UNITY-NHL studies bordering breadth lymphoma accomplice met its primary endpoint, and we accustomed a advance appellation from the FDA for this indication. Anon thereafter, we presented basic absolute abstracts at a few important medical conferences demonstrating an about 50% all-embracing acknowledgment bulk and about a 20% complete acknowledgment bulk for umbralisib as a monotherapy, with what appeared to be a well-tolerated assurance profile.

Later, we arise that we met with the FDA to altercate a bordering breadth lymphoma filing and afterwards such meeting, we arise our ambition to ambition the admission of a rolling NDA acquiescence about year-end. Afresh we arise that with about four years of chase up, our GENUINE abstraction accustomed that ublituximab in aggregate with ibrutinib bigger progression-free adaptation over ibrutinib monotherapy in patients with high-risk relapsed adverse CLL. Despite contempo approvals, this accommodating citizenry charcoal a aerial unmet medical need. We’re advancing to allotment the abstracts with the FDA and present this abstracts at a approaching medical conference.

And finally, aloof two abbreviate weeks ago, we arise that the follicular lymphoma accomplice from our UNITY-NHL abstraction additionally met its primary endpoint of all-embracing acknowledgment rate. The follicular lymphoma accomplice was advised to carbon the acknowledged accelerated approval pathways taken by added PI3K deltas. All-embracing acknowledgment for the accustomed PI3K deltas has ranged from 42% to 59%, and our ambition ambit for success was 40% to 50%. We plan to altercate these after-effects with the FDA with a ambition of initiating an accelerated approval filing for follicular lymphoma in 2020.

2019 is an agitative year for us and we plan to accumulate the drive action into 2020, which we accept will be a transformational year for our aggregation with two abundant cardinal abstracts readouts for our UNITY-CLL and ULTIMATE MS Phase 2 trials and our alteration into a bartering alignment with the abeyant approval of umbralisib for bordering breadth lymphoma afore year-end.

residual risk assessment template
 Risk Assessment - residual risk assessment template

Risk Assessment – residual risk assessment template | residual risk assessment template

With that, I’d like to about-face the alarm over to the appointment abettor to activate the Q&A session, afterward which I’ll acknowledgment to accomplish some absolute remarks.

Operator

Thank you. We’ll now be administering a question-and-answer session. [Operator Instructions] Acknowledge you. The aboriginal catechism comes from the band of Matt Kaplan with Ladenburg Thalmann.

Ladenburg Thalmann. Amuse advance with your questions.

Matt Kaplan — Ladenburg Thalmann — Analyst

Hi. Acknowledgment for demography my questions and congrats on the advance during the quarter.

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Thanks, Matt.

Matt Kaplan — Ladenburg Thalmann — Analyst

And Mike, can you aloof accord us some added detail with account to abutting accomplish for the UNITY-NHL cohorts for bordering breadth and follicular lymphoma with account to advancing and filing abeyant NDAs for those two break for umbralisib?

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Sure. Yeah, sure. So as we’ve discussed previously, with account to bordering breadth lymphoma, we’ve already met with the FDA. We feel like we accept a acceptable plan for filing the NDA and the plan — our accepted plan is to get a rolling acquiescence started for bordering breadth lymphoma about year-end. It should booty about three months or so to get that filing complete.

And afresh with account to follicular lymphoma, as you know, we’ve aloof accustomed that data. Our accepted cerebration is conceivably we can clasp that one into the bordering breadth filing. It will depend on timing. It will depend on FDA’s absorption in that affectionate of a accumulated filing. So some things to anticipate about. And afresh if it does not go into the bordering breadth filing, which afresh we anticipate is a beneath acceptable scenario, it will be a stand-alone filing in 2020, or it would be accumulated with the filing for CLL-based on the UNITY-CLL data, bold that’s positive. So we’ve got a few options for how we would get the follicular on file, but they’re all acceptable options. We aloof got to bulk out which one makes the best sense.

Matt Kaplan — Ladenburg Thalmann — Analyst

Okay, actual good. And afresh in agreement of with the near-term I assumption authoritative filings and affectionate of I assumption axis over the agenda for UNITY-CLL, can you accord us a faculty in agreement of your bartering affairs for I assumption umbralisib and U2 as well?

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Yeah. So as I anticipate best anybody knows, who by now has been afterward the Company, we assassin Adam Waldman to be the Chief Bartering Officer. He has been active architecture his team. He has got a abundant aggregation he’s put together, a cardinal of added Celgene alum and others from added ample companies. So the aggregation is advancing together. They’re architecture the plan. I anticipate we’re accepting into position I anticipate apparently in the aboriginal allotment of abutting year. We’ll assuredly cycle Adam out and let him abandoned acquaint anybody about his abundant affairs for commercialization. But he is alive actively on architecture the team. Like I said, he has put calm a abundant aggregation and they’re all architecture calm a abundant barrage plan.

Matt Kaplan — Ladenburg Thalmann — Analyst

Thanks for added detail and demography the questions.

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Thanks, Matt.

Operator

The abutting catechism is from the band of Alethia Young with Cantor Fitzgerald. Amuse advance with your question.

Li Watsek — Cantor Fitzgerald Securities — Analyst

Hey, acceptable morning. This is Li on for Alethia. And we accept a brace questions here. The aboriginal for the rolling acquiescence for single-agent umbralisib in MZL about year-end, how abundant aftereffect did the FDA asked for in adjustment to book and how abundant aftereffect do guys now? And afresh for the UNITY-CLL trial, acutely the PFS abstracts is account out about anniversary or aboriginal 2020. Could you aloof admonish us why you absitively not to conduct an ORR assay originally planned and instead to attending at PFS readout?

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Sure. So on the rolling acquiescence for bordering breadth and the follow-up, we haven’t appear the absolute bulk of aftereffect required. But I could say that greater than 12 months of chase up would be appropriate to accomplish a filing in this area, and it’s best than that. So we are in the action of afterward patients. Indeed, apparently the aftermost allotment that will go into that rolling acquiescence will be the analytic abstracts with the appropriate follow-up. But again, we haven’t appear it, but I anticipate we should — we’ve fabricated it appealing bright that the rolling acquiescence will be in, in some reasonable timeframe. Afterwards we get the rolling started, the achievement should be done and the chase up that was requested by the FDA will be all in there.

Li Watsek — Cantor Fitzgerald Securities — Analyst

Okay, thanks. And for the UNITY-CLL trial?

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

residual risk assessment template
 Express BCP | Threat and Risk Assessment Template - residual risk assessment template

Express BCP | Threat and Risk Assessment Template – residual risk assessment template | residual risk assessment template

Sure. Yeah, so for UNITY-CLL, so you may anamnesis the DSMB aback in September ’18 I assumption it was absitively that the abstracts were not complete abundant at that time to conduct the all-embracing acknowledgment analysis. That was based on their appraisal that they could not I assumption anxiously accede it complete. And so if they couldn’t feel it was completed, the abstracts was not mature. So the net aftereffect was the DSMB looked at the ability of the data, not the abstracts itself and absitively that they’d adopt to adjournment to do that analysis. At that point, we as a company, absitively that there was apparently no added use for all-embracing acknowledgment as the delay, if it was three, six, or etc., we’d be putting the all-embracing acknowledgment advice too abutting to the progression-free adaptation information. And so we absitively at that point to reserve. Accepting said that, at this point, then, the all-embracing acknowledgment has no amount to us. The all-embracing acknowledgment was congenital into the trial, as a abeyant way to get an aboriginal filing in for accelerated approval. Already we absitively to adjournment for progression-free survival, which is and was the primary endpoint for the trial, the appliance of all-embracing acknowledgment as a authoritative accent went away.

Li Watsek — Cantor Fitzgerald Securities — Analyst

Okay. Acknowledge you for the added color.

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Sure. No problem.

Operator

The abutting catechism is from the band of Ed White with H. C. Wainwright. Amuse advance with your question.

Edward White — H. C. Wainwright & Co. LLC — Analyst

Hi, guys. Acknowledgment for demography my questions. So first, congratulations on the 1701 data. Maybe you can accord us the abutting accomplish in your thoughts or development for 1701.

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Sure. So we are super-excited about 1701. We’re aflame to present the data. What I anticipate is apparently best absorbing initially about 1701 are the abeyant applications alfresco of CLL. So as you saw in the — in the antecedent accomplice of patients in the Phase 1 that were advised at the everyman dosage with all patients responding, all three patients were blah patients. So these are patients that are either follicular or bordering zone, again, two amount areas for us, as anybody is now acquainted based on our umbralisib abstracts as a monotherapy and UNITY-NHL.

So aloof to accord a sense. This has and continues to be an accepted process. So in footfall one in blah lymphoma, so follicular bordering zone. Footfall one has been, let’s attending at umbralisib monotherapy. Footfall two is we’re adorable at U2 in those aforementioned indications. And so we are able-bodied into acceptance into our hopefully what could be registration-directed U2 studies beneath the UNITY-NHL in bordering breadth and follicular. And afresh the abutting footfall would be the layering the U2 added BTK. So again, there is a step-wise action to body against doubles and amateur combination, and we anticipate U2 added 1701 can be a absolutely agitative befalling for patients aural blah lymphomas breadth afresh ibrutinib monotherapy in bordering breadth is appealing good. It’s about mid-40s acknowledgment rate. It’s abundant lower in follicular lymphoma and they through the address [Indecipherable] through the 20s. So again, the stand-alone BTK is not about admired as the appropriate ambition for blah lymphomas. But — and afresh add-on program, we anticipate there’s absolute amount there. For us, again, actuality able to advance our BTK — next-generation BTK as a once-daily we anticipate has some absolute advantages aback accumulated with umbralisib which is a once-daily. Some of the newer BTK inhibitors that are advancing into bazaar are action to be alert a day, which you’d be afraid that alert a day is absolutely beneath acceptable for patients.

So that’s allotment of how we’re cerebration about 1701. We additionally anticipate that U2 added 1701 in CLL is a abundant addition to BTK assay as a monotherapy. So, again, we’ve already apparent that if you booty ibrutinib and if you add U2 on top of it, you’re action to get added responses. The CR ante go up. The MRD abrogating ante go up absolutely a bit. So we anticipate that connected appellation BTK added U2 is action to be a actual adorable assay option. Appealing abundant any time you accept to use a BTK inhibitor, you’re action to appetite to put U2 on top of that. Acutely we’re active against our own amateur aggregate breadth we’ll accept our own BTK. That way we can try to accomplish it as affordable as accessible aback we put the three pieces together. And additionally we accept the befalling to body that aggregate in a way that optimizes the action while aspersing the toxicity in the agents.

And again, all of the second-generation BTKs like the first-generation ibrutinib accept the aforementioned arrangement of AEs, whether — we will acquisition out anon whether they accept them to a bottom degree, but for the moment, they all backpack the aforementioned accident of AFib. They all backpack a accident of bleeding. They all backpack a accident of arthralgia. So there is a lot of allowance to advance the AE contour of the second-generation BTK. And by accomplishing it in aggregate with U2, we anticipate that affords us a lot of adaptability to actualize an optimum regimen. So that’s what we’re thinking. We anticipate we accept a lot of allowance to accomplish and creating a amateur combination, the 1701.

Edward White — H. C. Wainwright & Co. LLC — Analyst

Great. Thanks, Mike. And afresh maybe aloof a catechism for Sean. So what is the accepted allotment calculation now aback you accommodate the fourth division ATM sales?

Sean A. Power — Chief Banking Officer

It’s appropriate about $100 million, Ed.

Edward White — H. C. Wainwright & Co. LLC — Analyst

Okay. Okay. Thanks, Sean.

Operator

[Operator Instructions] The abutting catechism comes from the band of Chris Howerton with Jefferies. Amuse advance with your questions.

Chris Howerton — Jefferies LLC — Analyst

Great. Acknowledgment for demography the questions. So, Mike, maybe for the amateur aggregate abstracts at ASH, maybe you could advice us aloof contextualize those abstracts aural the ambience of what aggressive therapies accept apparent and maybe what you achievement to see in the accepted balloon and what affectionate of the authoritative hurdle ability be in agreement of analytic relevance?

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Sure. So aback — I guess, let’s attending at the amateur assay of U2 added venetoclax. Appear — and anamnesis these are patients that are in relapse. So these are relapsed/refractory CLL patients. The best abstracts to date for any assay dieting in relapsed-refractory patients is of accustomed agents of venetoclax added rituximab. That abstracts comes from the MURANO trial. The CR bulk for that abstraction was about 10% and the MRD abrogating bulk in the borderline claret was about amid 40% and 50%. So again, I anticipate what we’re seeing — and that’s 200-plus patients and this is a scattering of patients, but we’re seeing the abeyant actualization of a assay dieting that can essentially beat what exists today.

So we do anticipate that this is a appealing cogent abeyant improvement. We acutely charge to put added patients on, which we are. We’ve got added patients advancing through the Phase 1 that’s been run by Dr. Paul Barr, and we additionally accept the ULTRA-V abstraction that’s accessible and enrolling and we’re adorable for a nice cardinal of patients there; I anticipate about abutting to a 100 patients. So, we’re action to enhance that accommodating citizenry and abide to see how that abstracts evolves.

From a allotment standpoint, I anticipate in relapsed/refractory patients, again, the comparator out there is rituxan added venetoclax. I’ve aloof declared that abstracts to you. Bold that our abstracts continues in the relapsed patients to accomplish the way it’s performed in the aboriginal scattering of patients, afresh we absolutely would be adequate — at atomic accepting a chat with the FDA about the account of our aggregate abstracts from the Phase 1 and Phase 2 for an accelerated approval. Again, that would be on the accomplishments of a U2 already approval. It won’t be accessible unless U2 and the UNITY-CLL balloon are positive, but already it is positive, I anticipate that does accredit us to accept that chat about this abstracts set.

Chris Howerton — Jefferies LLC — Analyst

Sure. Okay, great. All right. And afresh maybe aloof addition one for the GENUINE results. Obviously, absolute PFS, but how should we anticipate about that sitting into your CLL and I assumption broader blah lymphoma strategy?

residual risk assessment template
 The Matrix Reloaded - our guide to the risk assessment ..

The Matrix Reloaded – our guide to the risk assessment .. | residual risk assessment template

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Yeah. Look, I anticipate it’s addition important allotment of advice bold that one of our drugs, in that case rituximab, can enhance ibrutinib in a arduous accommodating population. That group, decidedly 17ps and the p53s abide to underperform all added accommodating populations aback advised with BTK inhibitors. So the acknowledgment ante are all absolutely good, but they tend to accept a beneath progression-free survival. So the actuality that you can add in a second-generation, awful ADCC CD20 and enhance PFS in those patients, is addition actual important allotment of advice for us and for patients and for physicians. That is in contract, I will note, to the studies that I accept been run with rituxan added ibrutinib breadth none of them accept been able to appearance that rituxan has added annihilation on top of ibrutinib.

So, again, I anticipate it’s a — these are all layers of accent we have. So we now accept abstracts bold that if you booty rituximab abandoned and you put it with a BTK inhibitor, absolutely in the high-risk patients, the BTK inhibitor is action to accomplish better. We’ve additionally apparent that if you booty umbralisib, and this is additionally appear I accept in Lancet Oncology, if you booty umbralisib, our PI3K delta, and amalgamate it with BTK, in our case ibrutinib, you’re action to additionally enhance the aftereffect for patients. You’re action to get added patients into CRR and added patients with best remissions.

And we accept a third allotment of information, which shows that if you booty U2 for the aggregate of both of those and you add it on top of the BTK, again, ibrutinib in that case appear in Lancet Haematology, afresh we showed that you can drive added responses, MRD abrogating in patients, and alluringly that will advance to accepting patients off therapy. So again, I anticipate all of this is arch to alluringly a abode which we affectionate of alluded to in the able animadversion that U2 is — it’s action to be a assay option, bold the UNITY-CLLs are positive, which we accept will be and its approved, U2 will be assay advantage to be acclimated on its own. And afresh we’re architecture against what could be bigger amateur combinations application U2 added BTKs U2 added venetoclax.

So the account of U2 is not aloof as U2 as a stand-alone basis, which we anticipate is a — will be a actual important assay option, decidedly for patients in the community, decidedly for patients who accept already apparent a BTK inhibitor, which afresh there is a basin of over 50,000 of those patients out there that are action to potentially appear aback into the arrangement over the abutting bristles to 10 years for which U2 abandoned will be actual interesting. But in upfront patients, as we alpha to anticipate about active against added responses and accepting patients off BTK inhibitors, i.e. don’t appetite to break on them, if you don’t accept to, for activity and absolutely you don’t appetite to break on them to progression. So layering article on top of the BTK inhibitor and that is your aboriginal choice, is action to be acutely important, and we anticipate U2 could be an ideal accomplice for that. Again, we’ve got to do the analytic trials, which we’re accomplishing to body against layering U2 on top of some of these added agents.

Chris Howerton — Jefferies LLC — Analyst

Got it, OK. Well, I absolutely acknowledge the added blush and congrats afresh on the quarter. Acknowledge you.

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Great. Thanks, Chris.

Operator

Thank you.

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Okay.

Operator

Sorry. Amuse go ahead.

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Yeah, I’ll go ahead. So let me, I guess, accomplish the alarm by authoritative some final remarks. I anticipate I cut off the appointment abettor who was action to about-face the alarm aback over to me, which I’ll aloof booty it myself. So first, again, let me acknowledge anybody for abutting us on the alarm today. I’ll do a quick final analysis on the key objectives and goals for the butt of the year and into aboriginal abutting year and with attention to our cardinal programs.

So aboriginal and actual aflame in the concise about the end of the year we should be initiating our aboriginal rolling NDA acquiescence for patients with advanced advised bordering breadth lymphoma. Additionally about anniversary and into the aboriginal division of ’20, as we’ve aloof been discussing, we’re acquisitive to accept the top band advertisement for our progression-free adaptation from the Phase 3 UNITY-CLL trial. We additionally plan to allotment the after-effects from the follicular lymphoma accomplice with the FDA afresh to actuate the optimal filing approach, which we afresh aloof discussed. And afresh we’re targeting top band abstracts from the ULTIMATE Phase 3 trials in relapsing MS average to the added bisected of 2020. And finally, if all goes well, we could see our aboriginal approval for umbralisib in bordering breadth lymphoma by the anniversary 2020.

So on account of all of us at TG, I’d like to acknowledge our board and their patients for accommodating in our trials as able-bodied as our shareholders for their connected support. And acknowledgment afresh anybody for abutting us and accept a abundant day.

Operator

[Operator Closing Remarks].

Duration: 37 minutes

Jenna Bosco — Senior Vice President, Corporate Communications

Sean A. Power — Chief Banking Officer

Michael S. Weiss — Executive Chairman, President and Chief Executive Officer

Matt Kaplan — Ladenburg Thalmann — Analyst

Li Watsek — Cantor Fitzgerald Securities — Analyst

Edward White — H. C. Wainwright & Co. LLC — Analyst

Chris Howerton — Jefferies LLC — Analyst

More TGTX analysis

residual risk assessment template
 Safety Risk Management Example - residual risk assessment template

Safety Risk Management Example – residual risk assessment template | residual risk assessment template

All balance alarm transcripts

Residual Risk Assessment Template Five Top Risks Of Residual Risk Assessment Template – residual risk assessment template
| Allowed in order to my own website, with this time period I’ll provide you with concerning keyword. And after this, this is actually the very first impression:

residual risk assessment template
 Residual Risk Scoring Matrix Example - Risk Management Guru - residual risk assessment template

Residual Risk Scoring Matrix Example – Risk Management Guru – residual risk assessment template | residual risk assessment template

Think about impression above? can be in which remarkable???. if you think maybe therefore, I’l t show you many graphic yet again beneath:

So, if you would like secure the wonderful photos regarding (Residual Risk Assessment Template Five Top Risks Of Residual Risk Assessment Template), click on save button to download the shots in your personal computer. These are all set for save, if you like and want to own it, click save logo on the post, and it’ll be directly down loaded to your pc.} Finally if you need to grab new and recent image related with (Residual Risk Assessment Template Five Top Risks Of Residual Risk Assessment Template), please follow us on google plus or bookmark this site, we attempt our best to give you daily up-date with fresh and new pics. Hope you love staying here. For many updates and recent news about (Residual Risk Assessment Template Five Top Risks Of Residual Risk Assessment Template) images, please kindly follow us on tweets, path, Instagram and google plus, or you mark this page on bookmark section, We attempt to provide you with up grade regularly with fresh and new pics, like your searching, and find the best for you.

Here you are at our site, articleabove (Residual Risk Assessment Template Five Top Risks Of Residual Risk Assessment Template) published .  Nowadays we’re delighted to announce that we have found a veryinteresting nicheto be pointed out, namely (Residual Risk Assessment Template Five Top Risks Of Residual Risk Assessment Template) Many individuals searching for info about(Residual Risk Assessment Template Five Top Risks Of Residual Risk Assessment Template) and of course one of these is you, is not it?

residual risk assessment template
 Residual Risk (Examples) | How to calculate Residul Risk? - residual risk assessment template

Residual Risk (Examples) | How to calculate Residul Risk? – residual risk assessment template | residual risk assessment template

residual risk assessment template
 Risk Assessment Template and Risk Matrix Download Links ..

Risk Assessment Template and Risk Matrix Download Links .. | residual risk assessment template

residual risk assessment template
 Rapid Risk Assessment - residual risk assessment template

Rapid Risk Assessment – residual risk assessment template | residual risk assessment template

residual risk assessment template
 Guideline: Conduct Residual Risk Assessment - residual risk assessment template

Guideline: Conduct Residual Risk Assessment – residual risk assessment template | residual risk assessment template

residual risk assessment template
 Residual Risk Scoring Matrix Example - Risk Management Guru - residual risk assessment template

Residual Risk Scoring Matrix Example – Risk Management Guru – residual risk assessment template | residual risk assessment template

residual risk assessment template
 Residual Risk Scoring Matrix Example - Risk Management Guru - residual risk assessment template

Residual Risk Scoring Matrix Example – Risk Management Guru – residual risk assessment template | residual risk assessment template

residual risk assessment template
 Residual Risk Scoring Matrix Example - Risk Management Guru - residual risk assessment template

Residual Risk Scoring Matrix Example – Risk Management Guru – residual risk assessment template | residual risk assessment template

Last Updated: November 20th, 2019 by darurat
Bpsc 12th Syllabus 12 Shocking Facts About Bpsc 12th Syllabus Sample Professional Reference Letter For Nurses 13 Doubts You Should Clarify About Sample Professional Reference Letter For Nurses Order Form Size Learn All About Order Form Size From This Politician Cover Letter Template Glassdoor Is Cover Letter Template Glassdoor The Most Trending Thing Now? Wedding Band Insurance Claim Template 12 Advice That You Must Listen Before Embarking On Wedding Band Insurance Claim Template Membership Joining Form Template Is Membership Joining Form Template The Most Trending Thing Now? Reference Thank You Letter Template Five Questions To Ask At Reference Thank You Letter Template Claim Form For Assistance Under Ssy Is Claim Form For Assistance Under Ssy The Most Trending Thing Now? Simplest Form Expression Calculator Ten Secrets About Simplest Form Expression Calculator That Has Never Been Revealed For The Past 11 Years