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How to do a grounded theory study: a worked example of a study of ..
How to do a grounded theory study: a worked example of a study of .. | 11 5 practice analyzing data form k answers

Once again, ladies and gentlemen. Welcome to Geron’s Fourth-Quarter and Full-Year 2017 Earnings Appointment Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer affair and instructions will be provided at that time.

[Operator instructions]. Now, I’d like to acquaint your host for today’s appointment Anna Krassowska, arch of broker relations. Amuse go ahead.

Thank you, John. Acceptable morning, everyone, and acknowledge you for aing us for the Geron’s Fourth-Quarter and Year-End 2017 Earnings Call. With me this morning are Dr. John Scarlett, our admiral and arch controlling officer; and Olivia Bloom, our controlling carnality president, finance, and arch banking officer.

On Friday we issued a columnist absolution that appear after-effects for the fourth division and year concluded December 31, 2017. This absolution can be activate on our website at www.geron.com. Today’s alarm is additionally actuality webcast alive on our website and will be accessible for epitomize through April 20, 2018.Before we begin, amuse agenda that except for statements of absolute fact, the statements during this appointment alarm are advanced statements beneath the Safe Harbor accoutrement of the Private Balance Litigation Reform Act of 1995. These include, afterwards limitations, statements regarding, the expectations, plans, timelines and affairs for imetelstat, including the connected development of imetelstat by Janssen through the IMbark and IMerge analytic trials, and abstracts from the analytic balloon advance imetelstat is safe and able but Janssen will accomplish a assiduity accommodation and that Geron expects it to action by the end of the third division of 2018, abeyant milestones and payments beneath the Janssen accord acceding and banking or operating projections or requirements.

These statements absorb risks and uncertainties that can account absolute after-effects to alter materially from those in such advanced statements. These risks and uncertainties accommodate afterwards limitation whether imetelstat shows assurance and ability in IMbark and IMerge, Janssen decides to abide developing imetelstat and provides a absolute assiduity accommodation and, if so, informs Geron by the end of the third division of 2018, the FDA and added advice authorities or IRBs or any added factors adapted that IMbark and/or IMerge be delayed or discontinued and Geron will absolutely accept assiduity anniversary and ability payments from Janssen on the acceding in the accord agreement. Added advice and factors that could account absolute after-effects to alter materially from those in the advanced statements are absolute in Geron’s alternate letters filed with the Balance and Exchange Commission beneath the branch ‘Risk Factors’, including Geron’s Anniversary Report on Anatomy 10-K for the year catastrophe December 31, 2017. Undue assurance should not be placed on advanced statements which allege alone as of the date they are fabricated and the facts and assumptions basal the advanced statements may change.

Except as adapted by law, Geron disclaims any obligation to alter these advanced statements to reflect approaching information, contest or circumstances.We will activate today’s alarm with a arbitrary of the 2017 fourth-quarter and anniversary operating after-effects from Olivia and afresh Chip will assay advancing activities of the imetelstat analytic trials actuality conducted by Janssen. Olivia?

Olivia K. Bloom — Controlling Carnality President, Finance, Arch Banking Officer, and Treasurer

Thanks, Anna. Acceptable morning. For the fourth division of 2017, we appear a net accident of $7.4 million, or $0.05 per share, compared to $8.5 million, or $0.05 per allotment for the commensurable 2016 period. For the year concluded December 31, 2017, we appear a net accident of $27.9 million, or $0.18 per share, compared to $29.5 million, or $0.19 per allotment for the commensurable 2016 period.Revenues for the fourth division of 2017 were $191,000, compared to $94,000 for the commensurable 2016 period.

Revenues for the year concluded December 31, 2017, were $1.1 million, compared to $6.2 actor for the commensurable 2016 period. Revenues in 2016 included the abounding acceptance of an upfront acquittal of $5 actor from Janssen Pharmaceuticals Inc. beneath a authorization acceding that was active in September 2016 for assertive rights of specialized oligonucleotide courage allure and atypical amidates.Research and development costs for the fourth division of 2017 were $2.5 million, compared to $4.1 actor for the commensurable 2016 period. Assay and development costs for the year concluded December 31, 2017, were $11 million, compared to $18 actor for the commensurable 2016 period.

The all-embracing abatement in assay and development costs in 2017, compared to 2016 primarily is due to lower costs for our commensurable allotment of analytic development costs beneath the imetelstat accord with Janssen Biotech Inc. and bargain personnel-related costs.General and authoritative costs for the fourth division of 2017 were $5.5 million, compared to $4.8 actor for the commensurable 2016 period. Accustomed and authoritative costs for the year concluded December 31, 2017, were $19.3 million, compared to $18.8 actor for the commensurable 2016 period. The all-embracing access in accustomed and authoritative costs in 2017, compared to 2016 primarily is a net aftereffect of college non-cash stock-based advantage bulk and added consulting bulk partially account by lower acknowledged costs.Interest and added assets for the fourth division of 2017 were $375,000, compared to $321,000 for the commensurable 2016 period.

Interest and added assets for the year concluded December 31, 2017, was $1.4 million, compared to $1.2 actor for the commensurable 2016 period. The access in absorption and added assets for 2017, compared to 2016 primarily reflects college yields on the company’s bankable balance portfolio. We concluded 2017 with $109.2 actor in banknote and investments.For 2018, we are bulging an operating bulk bake amid $25 actor to $30 actor of which about $10 actor to $12 actor is accustomed to be for our commensurable allotment of bulk to abutment the IMbark and IMerge trials beneath the Janssen collaboration; about $8 actor to $9 actor for personnel-related costs and about $7 actor to $9 actor for accumulated bulk such as business development, legal, accounting, IT and facilities. This bump does not accommodate any changes to the imetelstat development affairs or any accretion costs associated with accepting a new oncology asset, affairs or aggregation and any afterwards development bulk accompanying to such an acquisition.

Of course, if such abeyant changes were to occur, we would charge to alter our projections and depending on the timing and aftereffect of those changes, we would charge to seek added capital. Maintaining acceptable banking assets enables us to promptly acknowledge to such abeyant changes.I will now about-face the alarm over to Chip to assay contempo aggregation events. Chip?

John A. Scarlett — President, Arch Controlling Officer, and Director

Thanks, Olivia. Acceptable morning, everyone, and acknowledge you for joining. This morning I’ll alpha my animadversion with a arbitrary of the after-effects from the latest centralized abstracts assay conducted by Janssen on the IMbark and an alter on the projected timing of the protocol-specified primary assay for IMbark and the afterwards abeyant assiduity accommodation from Janssen. I’ll afresh accomplish with the cachet of the IMerge balloon including a epitomize of the abstracts that was afresh presented at the American Society for Hematology, or ASH, Anniversary Affair that was in aftermost December.As a reminder, IMbark is a Appearance 2 analytic balloon advised to assay two doses of imetelstat, 9.4 milligrams per kilogram or 4.7 milligrams per kilogram administered every three weeks in the intermediate-2 or high-risk MF patients who are adverse to or accept relapsed afterwards assay with the JAK inhibitor.

The planned March 2018 abstracts assay was primarily conducted to accredit a agreement alteration that will acquiesce the abiding assay and aftereffect of patients in the balloon including for survival. In reviewing the abstracts which was based on January 2018 abstracts cut, the collaboration’s Joint Steering Committee or JSC fabricated the afterward observations.First, the assurance contour was constant with above-mentioned analytic trials of imetelstat in hematologic malignancies and no new assurance signals were identified. Second, aftereffect measures for ability including annoyance aggregate responses and reductions in absolute evidence account abide constant with the above-mentioned abstracts reviews. Third, with a boilerplate aftereffect of about 19 months as of the January 2018 abstracts cut, the boilerplate all-embracing adaptation has not been accomplished in either dosing arm.Following the accompaniment of review, the JSC implemented a cardinal of actions.

First, the balloon is actuality acutely bankrupt to new accommodating enrollment. From the aboriginal enrolled accommodating in September of 2015 to the aftermost accommodating enrolled in October of 2016, added than 100 patients accept been enrolled in IMbark. This cardinal is accustomed to be able to appraise all-embracing survival. Patients who abide in the assay appearance may abide to accept imetelstat and until the primary analysis, all assurance and ability assessments are actuality conducted as planned in the agreement including afterward patients to the admeasurement accessible until afterlife to accredit an appraisal of all-embracing survival.

Second, based on the bulk of deaths occurring in the trial, the JSC bent that the IMbark protocol-specified primary assay which includes an appraisal of all-embracing adaptation will activate by the end of the added division of 2018. Upon the achievement of the protocol-specified primary analysis, the capital balloon will be completed. As a third action, the JSC bent that Janssen will alter the IMbark agreement to authorize an addendum appearance of the balloon to accredit patients actual in the assay appearance to abide to accept imetelstat per investigator discretion. During the addendum phase, accustomed abstracts accumulating will primarily abide of assurance information.

Patients will be connected to be followed for survival.The appraisal of adaptation is important because we accept that a new assay that could affirm bigger would represent allusive analytic aftereffect for patients who are relapsed or adverse to the alone accustomed MF assay today. As acquaintance with JAK inhibitors increases both in the absolute apple and analytic trials settings, we apperceive that the majority of MF patients abort or stop JAK inhibitor assay and abstracts from contempo abstract and added sources advance that the adaptation of these patients is limited. For example, an assay of real-world abstracts conducted by Janssen and presented at ASH in 2016 advised assay patterns and outcomes of MF patients from two U.S. medical claims databases.

This assay adapted that already patients abort or abandon ruxolitinib, beggarly all-embracing adaptation is about seven months. Three added afresh appear absolute affidavit anecdotic outcomes of MF patients afterwards alternate JAK inhibitor assay either in the ambience of a analytic balloon or through bartering accumulation estimated boilerplate all-embracing adaptation of about 14, 15, or 16 months respectively. Thus imetelstat potentially could abode a cogent unmet medical charge if its use is associated with adaptation that is advisedly best than 14 to 16 months.Moving to Janssen’s accommodation making, as we’ve commented previously, the achievement of the protocol-specified primary assay for IMbark is the activate for the assiduity accommodation by Janssen. Afterward achievement of that analysis, Janssen charge acquaint us of their accommodation whether to advance the authorization rights and abide the development of imetelstat or the assiduity decision.

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With the protocol-specified primary assay for IMbark accustomed to activate in the added division of 2018, we apprehend Janssen to accomplish its assiduity accommodation by the end of the third division of 2018. Although the achievement of the protocol-specified primary assay for IMbark is the activate for the assiduity accommodation by Janssen, we apprehend abstracts in MDS from IMerge to accord important advice about imetelstat.So let me assay that abstracts that was afresh presented at ASH in December. These abstracts abutment our antecedent that imetelstat may accept the abeyant to aish the admeasurement of cancerous antecedent corpuscle clones to acquiesce the accretion as a accustomed hematopoiesis in patients with hematologic malignancies. As we’ve declared previously, IMerge is the advancing balloon with imetelstat in patients with lower accident MDS syndromes, actuality conducted by Janssen.

IMerge is in two parts. Allotment 1 is a Appearance 2 open-label single-arm balloon administering imetelstat intravenously every four weeks at a dosage of 7.5 milligrams per kilogram. Allotment 2, not yet initiated, is advised to be a Appearance 3 abstraction that will be conducted afterwards Allotment 1 is completed and is advised to affirm in a randomized and controlled balloon the ability and assurance of imetelstat in the accommodating citizenry as able-bodied as dosing acclimated in Allotment 1.To be enrolled in IMerge, all patients charge accept relapsed afterwards or be adverse to assay aural ESA. In addition, patients charge be abased on red claret corpuscle transfusions acute at atomic 4 units of red beef during an eight-week aeon above-mentioned to access to the trial.

Among the 32 patients enrolled in IMerge, red claret corpuscle transfusions annex was high, the boilerplate red claret corpuscle admixture abounding at the access to the balloon with six units per eight weeks alignment from four to 14 units. In lower-risk MDS patients, abiding anemia is a absolute analytic problem. Assay aural an erythropoiesis-stimulating abettor or ESA such as EPO can accommodate an advance in anemia but the aftereffect is transient. As a result, abounding patients become abased on common red claret corpuscle transfusions to administer affection of anemia and fatigue.

Transfusion annex is associated with poor adaptation because of toxicity associated with an afflict as able-bodied as abeyant infections and allergic reactions. The ultimate ambition for best trials of investigational agents in lower accident MDS is to accredit patients to become admixture absolute for as continued as possible. Therefore, the primary endpoint for both genitalia of IMerge is the bulk or allotment of patients who accomplish red claret corpuscle admixture ability for at atomic a afterwards 8-week period. This has been a key authoritative endpoint in abounding disorders associated with anemia and admixture requirements.Secondary endpoints in IMerge accommodate the bulk of 24-week admixture ability and the bulk of hematologic improvement.

Hematologic advance is the bulk to which the abundance of transfusions is bargain and increases in serum claret levels are observed. In addition, assorted measures accept the backbone of these admixture and hematologic responses to imetelstat assay are additionally actuality adjourned for IMerge.Data presented at ASH were from the aboriginal 32 patients enrolled in Allotment 1 of IMerge application an October 2017 abstracts cut with a boilerplate aftereffect of 66 weeks. I’ll accord the after-effects of the accomplished 32 accommodating cohorts first. 38% of these patients accomplished red claret corpuscle admixture ability abiding for at atomic eight weeks.

16% of patients did not crave a admixture for at atomic 24 weeks with the boilerplate continuance of admixture ability above one year and abiding rises in claret by at atomic 1.5 grams per deciliter from pre-treatment levels. These ability after-effects represent clinically allusive outcomes with a abstruse appulse on a patient’s affection of action and accommodate added admiring abstracts that imetelstat exhibits abeyant disease-modifying action by suppressing the cancerous antecedent corpuscle clones that drive the basal disease.It’s additionally account acquainted that about all patients accomplished some abridgement in admixture accountability with the boilerplate about admixture accountability actuality bargain by about two-thirds compared to baseline levels. Also, the bulk of greater than eight-week red claret corpuscle admixture ability did not alter based on the attendance of arena sideroblasts, advertence action of imetelstat above altered subtypes of MDS.Now, in accession to the assay of all 32 patients in Allotment 1, Janssen additionally evaluated the after-effects of imetelstat assay in a subset of patients who’d accustomed assertive above-mentioned treatments which I would like to animadversion on next. So to set the date for evaluating the after-effects of imetelstat assay in this subset of patients, let me aboriginal animadversion that in the U.S.

hypomethylating agents or HMAs are accustomed for the assay of both lower-risk and high-risk MDS patients and the immunomodulatory abettor lenalidomide is accustomed for the about 15% of lower-risk MDS patients with the abatement the abbreviate arm of chromosome 5, the alleged del(5q) abnormality.Physicians in the U.S., decidedly alfresco of the capital bookish centers, use both HMAs and lenalidomide broadly in lower-risk MDS because there are bound addition assay options available. In contrast, in Europe, HMAs are not accustomed for lower-risk MDS, nor is lenalidomide accustomed for non- del(5q) patients. As a consequence, actual few, if any, lower-risk European patients are advised with either lenalidomide or an HMA at atomic until their ache progresses and they can be characterized as higher-risk MDS patients.The aboriginal admittance and exclusion belief in IMerge did not bind the cardinal or blazon of added above-mentioned MDS patients [Inaudible] treatments the accommodating was accustomed to accept accustomed afore entering the trial. Amid the 32 patients enrolled in Allotment 1, we afterwards empiric that a subset of 13 patients had not accustomed above-mentioned assay with either an HMA or lenalidomide and additionally did not accept a del(5q) chromosome abnormality.

This 13 accommodating subset showed appreciably added backbone and bulk of admixture ability compared to the all-embracing balloon population. 54% of these patients accomplished red claret corpuscle admixture ability abiding for at atomic eight weeks while 31% accomplished an RBC admixture ability abiding for at atomic 24 weeks, compared to 38% and 16% appropriately in the all-embracing balloon population. These were actual absorbing ability outcomes.From a assurance perspective, imetelstat’s contour in Allotment 1 was constant with above-mentioned analytic trials of imetelstat in hematologic malignancies and no new assurance signals were identified. The adverse contest were agnate amid the all-embracing balloon citizenry in the 13-patient subset.

The best frequently appear adverse contest were cytopenias which were predictable, acquiescent with dosage abridgement or delays and capricious in best cases. Cytopenias included Grade 3 and Grade 4 neutropenia and thrombocytopenia. Dosage reductions or aeon delays due to adverse contest were adapted for 59% of patients.In accession to the [Inaudible] ASH in which these after-effects were reported, these abstracts were additionally discussed in detail by Dr. Azra Raza, an MDS able and one of the analytic board for IMerge, during an accident for investors that we hosted at the end of aftermost year.

The webcast of that accident is still accessible on our website and if you haven’t already listened to it, I would animate you to do so.We and Janssen accept that the after-effects from the 13-patient subset who were naïve to lenalidomide and HMAs and who lacked the del(5q) chromosomal aberancy adapted imetelstat could action lower-risk MDS patients a much-needed addition above-mentioned to above-mentioned to HMAs and lenalidomide treatment. Lower ante of 8-week admixture ability accept been appear advanced for both HMAs and lenalidomide in agnate lower-risk MDS accommodating populations. In allegory to the 54% 8-week admixture ability bulk empiric for imetelstat, the bulk empiric for HMAs was 17% and 27% was empiric for lenalidomide with no bigger assurance profiles at imetelstat. As such we apprehend that targeting this lower-risk MDS citizenry would not abate the citizenry of patients potentially acceptable for imetelstat but instead arrangement imetelstat advanced of HMAs and lenalidomide in the assay paradigm.As we appear in July aftermost year, Allotment 1 of IMerge was reopened to accept about 20 added patients who are non-del(5q) and naïve to HMA and lenalidomide treatment.

This is advised to access the acquaintance and affirm the benefit-risk contour of imetelstat in this aesthetic ambition population. With the about 20 added patients, the absolute cardinal of patients in Allotment 1 who are adumbrative of the aesthetic ambition accommodating citizenry will be about 30 which was the sample admeasurement originally proposed in the agreement for Allotment 1 on which a accommodation to move to Allotment 2 would be based.Enrollment of patients to the broadcast Allotment 1 began in November of aftermost year and was completed in November of this year, which was faster than anticipated, highlighting both the unmet charge in this accommodating citizenry and absorption in imetelstat amid analytic investigators. So we accessory advanced to this actual important year for imetelstat and Geron.Before we accessible the alarm to questions, I will acknowledgment that our chase and appraisal action to analyze and appraise oncology products, programs, or companies for abeyant accretion continues.So with that, operator, let’s accessible the alarm to questions, please.

Operator

[Operator instructions]. Our aboriginal catechism comes from Charles Duncan with Piper Jaffray. Your band is now open.

Charles Duncan — Piper Jaffray — Managing Director

Morning, folks. Acknowledgment for demography my catechism and congrats on the advance in the quarter. So had a brace of questions. I’ll try to be quick.

First of all, with attention to the IMbark agreement alteration to acquiesce patients to abide on biologic afterward the primary ability analysis, Chip, I’m apprehensive if you could accommodate us a little bit added color. Is that absolutely apprenticed by some addled analytic observations or do you see it aloof as acceptable practice? And can you accommodate any blush on the cardinal of patients that abide on biologic out of the almost 100 enrolled?

John A. Scarlett — President, Arch Controlling Officer, and Director

Thanks, Charles. Well, aboriginal of all, the alteration to abide to chase patients predominantly for adaptation is absolutely mostly based on a brace of things, I’d say. Aboriginal of all, it’s technically adapted because we were at the end of the defined assay aeon in the aboriginal IMbark agreement that was amorphous absolutely a few years ago now. So in adjustment to abide to chase patients, we aloof bare to alter the protocol, get it accustomed through belief committees and so forth.

So that’s really, I would say, the arch driver. And obviously, the acumen we capital to do that is because we still accept not apparent boilerplate adaptation accomplished in either of the aboriginal accoutrements in the study. So we’d like to abide at atomic through that point in time. So that absolutely dictates the agreement amendment, predominantly one of timing.Sorry, the added catechism that you had was?

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Charles Duncan — Piper Jaffray — Managing Director

Yeah, you apparently can’t acknowledgment this, but in acceding of the cardinal of patients that abide on the drug, do you accept any advice on that that you can provide?

John A. Scarlett — President, Arch Controlling Officer, and Director

No, we’ve not been giving those numbers as we’ve gone alternating and I advanced we’re activity to abide to not do so.

Charles Duncan — Piper Jaffray — Managing Director

OK. And afresh you did a nice job of summarizing some contempo reviews, what happens to patients post-JAK inhibitors and what to apprehend there at atomic historically. And, I guess, I’m apprehensive aback you accede the accommodating citizenry of MF patients that accept been on the JAK inhibitors in the trial, do you advanced that the sample is cogitating of the broader accommodating population. And if so, could you advice us accept are they all post-Jakafi patients or are there some of the patients who accept been on JAK inhibitors in analytic trials added than Jakafi.

John A. Scarlett — President, Arch Controlling Officer, and Director

Sure. So I do advanced that this citizenry was absolutely agnate to the broader accommodating population. That comes from a brace of observations. Aboriginal of all, we had absolutely no defined exact blazon of JAK inhibitor that patients had to accept been advanced apparent to.

Obviously, the all-inclusive majority of them were apparent to Jakafi itself, to ruxolitinib, but we absolutely accept bashful numbers of patients who had been apparent to added abeyant JAK inhibitors. I would alarm out decidedly momelotinib, fedratinib, and pacritinib. I’m not abiding the exact numbers. I would say apparently the majority aloof because of aback the timing of the abstraction was momelotinib but there accept been, as far as I anamnesis at least, at atomic baby numbers of appealing abundant all of the investigational agents at one time or addition afterwards patients had bootless them but the all-inclusive majority were absolutely acutely post-Jakafi or ruxolitinib.

Charles Duncan — Piper Jaffray — Managing Director

OK, that’s helpful. And the aftermost catechism is bent over to IMerge. I assumption I’m apprehensive aback would you advanced the aing alter and could this conceivably be at or afore Janssen assiduity decision?

John A. Scarlett — President, Arch Controlling Officer, and Director

This is my own appraisal and I don’t accept a specific acumen for adage it but I advanced it’s absurd that we’ll be giving any specific advice amid now and then. Obviously, we try to authority best of our abstracts for accurate affairs and we’re still means abroad from the archetypal affair area this would go which would be ASH, the end of the year, but I don’t absolutely know. I mean, we haven’t absolutely discussed these absolute affairs for either advertisement of top band or adumbration of top-line abstracts or, for that matter, added accessible abstracts. So I don’t absolutely apperceive adapted now.

I wouldn’t be captivation my animation though. I advanced that this abstracts is crumbling actual nicely. So let’s delay and see.

Charles Duncan — Piper Jaffray — Managing Director

OK, actual good. Acknowledgment for demography my questions.

Operator

Thank you. Our aing catechism comes from Chad Messer with Needham & Company. Your band is now open.

Chad Messer — Needham & Aggregation — Managing Director

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Great, thanks. Acceptable morning. Acknowledgment for demography my question. So for IMbark, it seems like the affiance actuality is a biologic for JAK failures that has potentially a acceptable adaptation account but conceivably not as abundant ability on some of the acceptable ability ambit like annoyance volume.

Is that a fair assuming of what the abstracts are cogent us so far? And if so, does that accomplish mechanistic sense?

John A. Scarlett — President, Arch Controlling Officer, and Director

Chad, acknowledgment for the question. It’s a actual absorbing and acceptable question. I advanced one of the things that we’ve acicular out in the accomplished and I would point out afresh is that aback best bodies advanced about annoyance aggregate acknowledgment ante and, for that matter, absolute evidence account reductions, they absolutely catch aback to the original, rather, I thought, absorbing abstracts apparent by ruxolitinib in frontline patients and, in fact, not alone in frontline patients but absolutely the aboriginal patients to anytime be apparent to a JAK inhibitor in any way, appearance or form. And you’ll anamnesis that there was a fair bulk of airheadedness alike there.

The FCR in COMFORT-I which was a U.S.-based abstraction was 42% in patients who were advised with ruxolitinib, frontline. Bethink again, frontline.In COMFORT-II, the European study, that aforementioned basal citizenry of patients, the FCR was 29%. And afresh I advanced the added affair to accessory at afresh is to say “All right. Well, we’re not in the frontline.” We are absolutely not in the frontline.

We are in patients who are at the far end of the added allotment of the spectrum, if you accessory at, for example, the momelotinib data, not necessarily with attention to momelotinib but alike with attention to the best accessible analysis arms, so in SIMPLIFY-2 the best accessible analysis are included, 88% of those patients got ruxolitinib. Now, these are patients who are second-line apparent and there they alone had a 5.8% annoyance aggregate abridgement by the archetypal methodology. PERSIST-2 had about bisected of the patients almost had ruxolitinib assay in their BAT arm and that was alone 3%.So my point is absolutely that aback you booty second-line patients or, in our case, absolutely backsliding or adverse patients, I think, attractive at annoyance aggregate acknowledgment ante and aggravating to adjudicator those adjoin aboriginal time anytime apparent to JAK patients actual aboriginal on, almost aboriginal on in their assay paradigm, I advanced you can be misled. So that’s why we’ve absolutely concluded up attractive predominantly at adaptation which is the ultimate aftereffect that everybody cares about.

So I alone accept that patients would not be blockage on the biologic if they were not accepting the account and I additionally advanced that if we are able to affirm cogent adaptation account in these patients who absolutely accept no added alternatives that this will be potentially a actual advantageous drug.How that plays out in a authoritative action and so forth, I’m not a 100% sure, cipher is, but I do advanced that we should not discount the about amount of added measures above annoyance aggregate acknowledgment and abnormally in drugs that are not absolutely advised accurately to abate the accessories of the ache that are anticipation to be accompanying to annoyance aggregate increase.

Chad Messer — Needham & Aggregation — Managing Director

OK, great. Acknowledgment for that. It’s actual helpful.

Operator

Thank you. Our aing catechism comes from Alex Schwartz with Stifel. Your band is now open.

Alex Schwartz — Stifel Banking Corp. — Carnality President

Hi, John [Inaudible]. Congrats on boilerplate OS not actuality reached. And acknowledge you for demography the question. So the aboriginal catechism I had, can you allocution added about the 4.7 mg/kg arm and if these patients remained on that dosage the absolute time or was the proposed Janssen agreement alteration accustomed and at what months did these patients crossover to college dosing?

John A. Scarlett — President, Arch Controlling Officer, and Director

So there are patients who remained in 4.7 milligrams per kilogram arm and did not cantankerous over to the 9.4. I don’t advanced we’ve anytime absolutely accustomed any specifics about that and I’m aggravating to bethink absolutely aback we implemented those agreement changes.

Olivia K. Bloom — Controlling Carnality President, Finance, Arch Banking Officer, and Treasurer

It was in October 2016. That’s aback Janssen did the aboriginal abstracts assay and it was at that time bent that the low-dose arm, the 4.7 mg/kg, didn’t accreditation added investigation. So accommodating acceptance in that arm was closed. A agreement alteration was candy at that time giving the board the advantage whether to leave their 4.7 patients on that arm, or they could dose-escalate to 9.4.

That was based on investigator choice.

John A. Scarlett — President, Arch Controlling Officer, and Director

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So that was against the end of 2016 and that’s aback some patients dosage escalated up to 9.4 but there were a allusive cardinal of patients who remained on 4.7. So did that acknowledgment your question?

Alex Schwartz — Stifel Banking Corp. — Carnality President

Yes, it did. Acknowledge you. And afresh a added catechism I had, affectionate of accustomed the unmet charge in MF patients afterwards Jakafi and your OS abstracts to date and maybe a added acquiescent FDA, any faculty that you charge to run a Appearance 3 balloon and what admeasurement ability that be or rather Appearance 2 abstracts that you accept today and maybe 100 patients may be acceptable for an NDA filing? Any thoughts about that?

John A. Scarlett — President, Arch Controlling Officer, and Director

Well, honestly, annihilation that I would say would be awful speculative. We’re still in the bosom of a lot of development here. I’ll accord you some accustomed thoughts, Alex, about that. You absolutely prefaced the catechism with some absorbing prefaces, one of them was a added acquiescent FDA.

I don’t apperceive if that’s accurate or not but I would say the following. Historically, as I advanced anybody on the alarm apparently knows, you charge a ascendancy arm in adjustment to accomplish a actual and an adapted accurate appraisal of all-embracing adaptation because you can be afraid by about changes in accommodating populations and so forth. And so that’s historically been the authoritative accustomed would be to present OS abstracts in the ambience of a ascendancy arm. We don’t accept a ascendancy arm here.

So that’s why we’ve been application absolute abstracts and accept affectionate of chaotic the abstract in adjustment to accessory for that.I will say this. I advanced that you can accomplish ample generalizations as we accept actuality about what we’re seeing and how it compares to the abstract which is now adequately consistent. 14 to 16 months appears to be the boilerplate OS for patients in a cardinal of altered aftereffect studies anxiously done in bookish centers in acceding of boilerplate OS afterwards declining or advancing off of JAK inhibitors and predominantly ruxolitinib. So you can judge, as you additionally prefaced, we haven’t accomplished the boilerplate OS yet.How that will comedy out regulatorily will appeal absolutely some accurate anticipation about the apple and additionally apparently some akin of alternation with experts.

At the moment, I don’t advanced we’re able to say what our affairs are with attention to that whether there will be an NDA filed, how that will absolutely go forward. We wouldn’t appetite to be accepting out advanced of some of those discussions and we still affectionate of charge to ability boilerplate OS in adjustment to absolutely apperceive area we are. So that’s where, I would say, things angle today.

Alex Schwartz — Stifel Banking Corp. — Carnality President

OK, excellent. Well, acknowledge you for the added accuracy and congrats on the progress.

Operator

Thank you. Our aing catechism comes from Philip Lee with Mangrove Partners. Your band is now open.

Philip Lee — Mangrove Partners — Analyst

Hi. Acknowledge you for demography my questions. I accept two quick questions. The aboriginal is aback you enrolled the IMbark trial, were there any minimum platelet counts all-important for the patients who enrolled or is there any advice you can accord us apropos their platelet counts?

John A. Scarlett — President, Arch Controlling Officer, and Director

Yes, we adapted at atomic 75,000 platelets.

Philip Lee — Mangrove Partners — Analyst

OK, acknowledge you. And my added catechism is if you could accord us any added abstracts apropos the ECOG Cachet and how that’s stratified amid 0, 1, and 2 at baseline for bodies enrolled in IMbark?

John A. Scarlett — President, Arch Controlling Officer, and Director

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We accept not appear that. That would be allotment of a publication. That’s usually not commodity that’s focused on as abundant in this field. Alike though, I acknowledge your absorption in this subject.

So we haven’t absolutely accustomed that.

Philip Lee — Mangrove Partners — Analyst

OK, acknowledge you actual much.

Operator

Thank you. This concludes our question-and-answer affair for today. So I’d like to about-face the appointment aback over to Anna Krassowska.

Anna Krassowska — Director of Broker Relations

Thank you, everyone, for aing us this morning. I aloof capital to accomplish a agenda that we will be accessory the Needham Healthcare Appointment aing anniversary on March 27. So maybe we’ll see some of you there and we will be giving a webcast presentation. So acknowledge you all.

Operator

Thank you. Ladies and gentlemen, that does accomplish today’s conference. Acknowledge you actual abundant for your participation. You may all disconnect.

Have a admirable day.

Duration: 47 minutes

Anna Krassowska — Director of Broker Relations

Olivia K. Bloom — Controlling Carnality President, Finance, Arch Banking Officer, and Treasurer

John A. Scarlett — President, Arch Controlling Officer, and Director

Charles Duncan — Piper Jaffray — Managing Director

Chad Messer — Needham & Aggregation — Managing Director

Alex Schwartz — Stifel Banking Corp. — Carnality President

Philip Lee — Mangrove Partners — Analyst

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More GERN analysis

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