Q3 2019 Earnings Call
Ladies and gentlemen, the operator to these calling for into scheduled to begin the momentarily until that time. Your line should again be please on home. Thank you for your patience.
Good afternoon, ladies and gentlemen, thank you for standing by as a reminder, you've always been degreed today's Wednesday August three 2019 at this time I would like to turn the conference over to child Ching Senior director of Investor Relations Officer Union. The Magic I think you.
Thank you John before we begin I'd like to remind everyone that during this call will be making forward looking statements made pursuant to the private Securities Litigation Reform I don't 1995, such statements may prove involve significant risks and uncertainties and therefore actual results could.
Differ materially from those expressed or implied on this call well factors that could cause such differences. Please refer to our regulatory filings with the Securities and Exchange Commission.
With us on the call today with the prepared remarks on both a phase on barrels a day executive chairman and with some other chief Financial Officer also on the call for Q and they is thought to new executive director. Following the prepared remarks, we will open the call for questions. Thank you based on.
Thank you Charles Good afternoon, everyone and thank you for joining us as noted during our Investor event at ESMO you had a meeting with you have seen late September to update the agency on our progress in addressing the matters raising the CRL getting alignment on the contents of the P.L.A. and review the timeline of our Resubmission.
[laughter] the meeting with the agency went well as we continued our constructive dialogue importantly, there were no changes to our plant that we previously agreed to at the May type a meeting and we are targeting the resubmission of the be late to occur in the late November early December timeframe.
Kudos to our quality of manufacturing teams, we've completed all BLE related manufacturing operations at Morris Plains and after our scheduled an annual maintenance shutdown, we are already back up and running routine manufacturing operations in preparation for commercial launch subject to approval.
I would like to take a moment here to express my gratitude and acknowledge the hard work put forth by our colleagues and getting up to this critical juncture.
Our focus now is on finalizing the ability resubmission and to be ready for the pre approval inspection when would we submit.
Since our review is with SEDAR. The FDA has officially 30 days to except the submission before sending to suddenly got an acknowledgment of receipt letter.
However, the FDA has full discretion to accept a filing prior to the expiration of the 30 day period.
In terms of the length of the review cycle, we do not want to speculate on behalf of the agency.
Our goal has always been to optimize the approval timeline by submitting a high quality and easily review B L. A lot, ensuring a structured and well prepared pre approval inspection, thus, allowing for a streamlined approval process.
Upon resubmission in anticipation of the potential launch we will be looking to bolster our commercial capabilities and complement the significant portion of our U.S. commercial infrastructure, we have been able to maintain through the creative and productive arrangement with John simple for belt ourselves.
Given that we've already completed the commercial launch preparation once before we believed that we well situated to refresh our plans and expect to be diligently prepared for a successful launch.
Moving onto a rapidly advancing clinical programs shortly after completing patient enrollment in the sense study in M.T.N.B.C., which we expect up topline read out in mid 2020. We have now also reached target enrollment into says flatten eligible cohort of 100 patients with metastatic urothelial cancer, what progress after probably do you mean checkpoint inhibitor.
And platinum based therapies in the trophy you were one study [noise].
Additionally, interim results from the patients from the initial 35 patient cohort what presented at ESMO 2019 Congress.
With an overall response rate of 29%. This interim results along with the adverse events were highly consistent with the previously established clinical activity in safety profile of Sacituzumab, Dolby T., Karen or S.G. and are encouraging relative to standard of care in this setting.
We are pleased to accomplish these important goals in M. you see I look forward to discussing the registrational path forward for SG in this important indications that the FDA.
The company has also expanded the clinical development of SG two additional metastatic solid tumors would the newly opened multi cohort open label phase two tropic. So three study having dose the first patient with non small cell lung cancer.
This is the first study conducted by the company, which a biomarker will be used to assess whether enrichment for trucks to expression may lead to high responses in certain indications.
The primary endpoint of this study's overall response rate would duration of response in progression free survival, serving the secondary endpoints.
One of our core values is to be patient centric people with complex cancers inspire and drive all work every day as we aim to tackle gaps in their care and helped improve their long lives.
Recognizing the critical unmet need for people with CNBC I'm very pleased that during this past quarter. We also entered into two important clinical collaborations.
To potentially advances to two earlier lines of breast cancer treatment.
Our collaboration with Roche will develop as gene the frontline setting of and CNBC by combining with to centric.
Patients with newly diagnosed MTN BC will be randomized to receive the combination of SGN to centric or abraxane plus to centric as standard of care.
Roche will be responsible for conducting this randomized study.
You know collaboration with the German breast group as she will be evaluated as a monotherapy in a multi nice national phase three study in the curative setting and hertwo negative breast cancer.
Approximately 1200 high risk patients, who do not achieved a pathological complete response falling standard neoadjuvant therapy will be randomized to receive either SG or treatment of physicians choice.
With these two collaborations we now have been placed programs that could address virtually every stage of t. NBC and across multiple lines of treatment.
String our competitive positioning TNBC and establishing SG as a foundational therapy in this indication.
Finally, as disclose at ESMO Investor event, we have initiated the preparation about marketing authorization application Europe and the process is ongoing.
Before I turn the call over to summer for an overview of the financials. Let me provide a quick update on the leadership team.
On the CMO search we have been fortunate that shortly after the position became vacant we identified a strong industry veteran who has helped us focus our clinical strategy and provide leadership to our clinical and regulatory organization.
Without continued rapid and successful progress across our clinical programs, we have pause on our CMO search to focus on the CEO position.
On that front, our objective remains to have a CEO in place as we approach commercialization.
And obviously, we will provide you with an update as warranted.
I would be remiss, however, not to mention that we have incredible stability and Kumar camaraderie among us senior management team, we are 100% focus on filing and preparing for successful launch and we firmly believe we have the right seem to get this chopped up.
With that well summer.
Thank you based on I will provide topline results on this call and ask everyone to refer to our quarterly filings as well as this afternoons earnings release for additional details.
Total cost and expenses were 86.8 million for the quarter and 233.6 million for the nine month ended September Thirtyth 2019.
Compared to 57.2 million for the comparable quarter.
And 148 million for the nine months ended September Thirtyth 2018.
The increases were due primarily to additional expenses in research and development sales and marketing, partially offset by decrease in GNS expenses.
Increases in R&D costs were mostly attributed to activities related to preparation for the approval in commercial launch of Sacituzumab will be tecan in MTN BC as well as expanded clinical development Apache into other indications.
Net loss attributable to stockholders was $94.3 million were 49 cents per share for the quarter ended December 32019, compared to 64.2 million were 34 cents per share for the comparable quarter ended September 32018.
Net loss attributable to stockholders was 257.6 million or dollar 34 per share for the nine months ended September 32019, compared to 216.7 million or $1.24 per share for the nine months ended September Thirtyth 20 team.
As of September Thirtyth, 2019, we had $36.2 million in cash cash equivalents in marketable security.
A number of outstanding shares was 192 million and the fully diluted count was 205.
We believe our projected financial results resources are adequate to support our clinical development plan for SG further build out our clinical and manufacturing infrastructure and fund our operations through 2020.
This concludes our third quarter 2019 financial results operator, please open the call question.
Thank you ladies and gentlemen, if you have a question at this time.
Right.
Ended number one.
You don't telephone if your question has to be downstream.
Thank you.
Press the pound key.
First question comes from the line of Jim friction from Wells Fargo. Your line is now open.
Hi, guys. Congrats on the progress during the quarter a couple of questions. I guess, just first on metastatic Urothelial cancer have you requested a formal meeting with FDA to discuss the regulatory path and maybe you could make some comments on how you think about breakthrough designation for that indication.
Sure Jim Thanks for the question I think will refrain from talking about the specific steps and perhaps leave it to the time when we have something meaningful to report on the outcome when and if that occurs but I think we've been always pretty transparent about this being a full interim analysis that would be potential.
The basis, all the breakthrough dialogue with the FDA and as low as you recall, we presented the data and did discuss that we would be waiting longer follow up period. So have the maturity to go to the FDA, but I think you have precedence to perhaps estimate roughly when that might occur.
And turning the registration.
No I was just going to say the registration path I think is sort of somewhat well trodden. If it's acceptable to go with the next single arm et cetera approval. This is a pivotal study that was designed to potentially serve that purpose and would then be followed with a confirmatory study that would be discussed with the FDA.
And then just on pre commercial plans can you maybe speak to what proportion of the sales force you retained and.
Whether you've made offers to.
Remaining reps you will require and maybe better timing around when you start trading so those reps that sort of thing.
Yeah, I think I mean, the short answer is by and large we maintained our entitled commercial sales foreseen.
The entire sales rep team.
And there has been very modest turnover, so when and if we back fill them would be sort of as we get closer to it but by and large the boulder. So relationship allowed us to maintain our entire presence in the field.
And obviously, they are idle well well prepared and ready to launch.
Just a final question just on on I guess the type a meeting and then the more recent meeting with FDA was there any discussion of the assent study and given the timing for topline data by mid year.
Any any comment from FDA, suggesting interest in that prior to ruling on on the delay.
No. The short answer is a neither conversation did this end topic come up and there was never an indication that that would be a rate determinant get keeping event that they'd be looking forward to its most streets related to just the CMC review and the dialogue is focused on the CRL items.
Perfect well, thanks for taking the questions.
Thanks, very much and.
Thank you next question coming from the lined up.
Kumar from Kentucky.
Your line is now.
Good afternoon, everyone and thanks for taking my questions I'll first four unit helium answer in a contract on completion of enrollment.
Cohort eight I was curious about the key more ineligible.
Hey, what's the current status and how should we think about the read out relative to our chemo.
Provision.
Sure. So the chemo analyzer patients continues to crew patients. It is a slower accruing cohort because those patients do go onto receive.
Various therapies that too is that disqualify them from an enrollment criteria standpoint.
It is however, just an exploratory arm and does not impact the cohort a or the 100 patient cohort that we just announced would be the basis of a dialogue with the FDA and potentially serve as a basis for an extended approval. This cohort of ineligible patients do not read into that at all.
The timeline can be just joints and disconnected.
Thank you Ben So then maybe one last.
Question on the triple negative breast cancer.
You know given its hard line.
You guys are filing our days upon from interest any ongoing.
I understand you have Astra zeneca partner shape of which I think that trial has not initiate and supposed to be in front line.
And then.
There's some other collaboration with bar.
But I was just wondering what the Nick how aggressive you guys are trying to pursue this frontline indication and when should we expect a meaningful data update from the frontline triple negative.
Sure. So obviously the front line on the combo is a high interest to us but in both instances the partners run the trial and governed the timeline. We are responsive we're supplying the drug and so we will certainly meet our end of that but we can't really control the timeline its endeavor hands.
I think I'll add one more thing Verona I think we've talked about this in the past.
All of our clinical collaborations are with partners.
Who have an infrastructure in place.
And can conduct the trials on their own that's one criteria the other one.
That we are in non exclusive agreements. So as you can see from the Roche agreement. We are very much focused in looking at opportunities in front line settings in combination with PD ones and we will continue to explore those opportunities with various partners moving forward as well.
And.
And it got study is that still on track to be initiated by end of this year.
We did not specify timeline, but we expect that the that this study will be will be coming up in the near future.
Okay. Thank you very much on SK.
Thank you next question comes from the line Paul.
From Goldman Sachs. Your line is now open.
Hi, Thanks, Ive two questions. The first is commercial and with regard to your promotional of the Jan J.F. GR I guess can you maybe comment on where your Salesforce is with regard to penetrating.
Accounts that might overlap for your TMB CE launch right right now and what is what have you wonder if your learnings band with regard to potentially getting sacituzumab govitecan into these accounts so next year.
Oh, yes.
I guess shot at that and the full summer has more to add up and certainly the community setting off in solid tumors are treated by the same physician. So I think with respect to building rapport and relationship with the reps with those physicians into community setting I think there's tremendous amount of overlap and obviously, we're not discussing sacituzumab with.
So there's really no.
Correct discussion on our drug, but I think just this year fact that we're building the relationships are going to be quite helpful. What if someone would reach that point of commercializing our own drug, which and as you know the balance of relationship and.
Oh by the end of the first quarter. So we'll be really ready to go immediately in the as of the first of the year, we'd be able to promote our drug.
In conjunction with that as well so there's really no hindrance that prevents us from getting to those positions with our reps that are not for small Chad. So I think that covers most of it.
While you May remember from discussion late last year as you were in commercial and then that we expect that split between community and academic is about.
Down the line and so it's very important that our sales reps have had the opportunity to really get to know the communities heading this year established call points establish those relationships because it will completely dovetail into our own commercial launch once our reps are up and running all on the training for our Sacituzumab will be.
Got so.
It was a creative deal and it it's it we expect that will pay dividends on multiple fronts.
Great. Thanks, Thanks for that but on the clinical side.
I was wondering if you could maybe.
A little more fine point on what Youre timing expectations are for potentially starting a.
Oh, plus Sacituzumab Govitecan trial, and bladder and then particularly in light of some of the competitive data presented at the.
Recent ESMO meeting do you have a view as to you know whether you'd want to focus on a drug combination Alta gate or think about sequencing as you lay out your trial design.
Yes, so the Io combination is certainly.
Something that is very top of mind for us, but also when do you feel sitting on we obviously saw the data you're referring to.
And given that our drug has shown activity I'll keep very small numbers, but nevertheless in a in line after EDI and given the toxicity profile should on paper at least it looks like we should be combinable with the checkpoints. We have every reason to believe that our data should also improve as we go up in line of therapy, and maybe get to front.
Line I think the safety profile of our drug was quite different with TV, so it'll be interesting to see whether.
That yields any differential profile and advantages.
With respect to thinking about going into later line that we don't really see a need I think these patients will.
You can respond to one or the other therapy and it will probably in the commercial setting be a very customized approach based on the patient profiles and is it certainly arent tend to be quite competitive from a positioning standpoint, but I think the physicians will ultimately make the choice based on what is the most suitable regimen for the into group individual patient that presents.
[noise] Oh sure actually my question was with regard to with what I meant by sequencing wise, whether you would see using <unk>.
80 see as a de bulking agent followed by Io therapy or would you think about using both drugs simultaneously, that's what I meant by sequencing.
See I noticed that thanks for the clarification.
We haven't seen too much evidence of de bulking with an 80 see versus an a.
Before the Io, but we will certainly be curious to see as they vote field evolved in dialogue with the FDA what is the optimal path, but I think from a pragmatic standpoint, just given the dosing regimen of than 80 see into the mechanism versus the Io.
I personally at least at this point would think that you would go and combine and rather than do it in sequence Debulking followed by but it's certainly something to two also further explore.
Great. Thanks for taking your questions.
Thank you.
Next question coming from the line Michael Schmidt from Guggenheim Your line.
Hey, Thanks for taking my questions, maybe one more on the Oh.
Yeah.
Back can you maybe talk a little bit about some of the things today doing.
Preparing the manufacturing facility.
Inspection.
Sure.
Yeah.
[noise] Scott you want to yeah sure I'm happy to talk to that the biggest like we're doing for to prepare for the pre approval inspection and keep in mind Weve.
Had dark overall quality improvement plan in place I'm really since last year I mean, we enhanced it significantly obviously as a result of the CRL and had been implementing at you know consistently and very effectively since that point in time as Bob said.
In any conversations we've had with the FDA right now they've not asked us or encouraged us to change our plans just continue to do more of what we're doing and that's exactly what we've done the biggest thing in terms of pre approval inspection readiness is to ensure that were in substantial compliance from cgmp implementing that plan. So we will be ready for free.
Ruble inspection when we re file to be like there's some logistical things you'd have to do if people are going through this before but the predominant venues that you've got a good sound operating environment with a good quality system in place, which is where we're at today.
Okay.
Thanks.
I'm going to say that from a a infrastructure standpoint, there's really nothing that we need to do the building is is there. The operations are up and running you just have to be in manufacturing mode. In general. The if you want to see people in action in motion and obviously as I said, we are back in our manufacturing mode and.
And making drug so.
We'll be ready when they visit.
Okay perfect. Thanks for clarifying and then just on the.
Frontline study in triple negative breast cancer.
Correct.
Just wondering I guess.
Yes market insights maybe to what degree to centric doctors now in triple negative breast cancer treatment.
The study.
PD.
Okay.
Thank you.
So on the on the Roche study I'm just to set the stage again. This is a SG plus centric against Abraxane plus to centric. It is stage studies. So there's there it it's assignments to say study with.
With interim markers that need to to pass into that the next day it's.
The primary endpoint is response rate with a secondary endpoint of duration of response.
Did I Miss This particular my question was on PDL, one positivity it is and it is in the initial cohort.
We are going after or the design it for a PDL one positive cohort, although we expect to overtime expanded to an all comers population as well.
With respect to the question of the standards of care now I think it is I don't have specific data, so, but but my understanding is that is in the U.S. predominantly being adopted now.
But I assume it's it's ramping but I think it will be considered standard of care.
Okay. Thank you.
Thank you.
Next question coming from the line of feel from Cowen and company. Your line is now.
Yes, thanks for taking my question.
First a two part question I understand.
Brazil from second my therapies ESMO suggested maybe three month PFS in that control arms.
Ministry Triple negative breast cancer any reason such PFS would not be replicated in the control arm of ascent and then second part of that question is PGC and blueprint recently, so DFI requested topline data from ongoing kind of confirmatory phase three trials for those agents because that it all give you pause about the need for topline data from a sent for the FDA. Thank you.
Thanks, Phil.
Caught your question right.
The first one is about whether our control arm would if there's reason to believe that it would do better than three months you were referring to the controlled arm specifically, yes. The control arm specific there's any reason why we can't take that data from ESMO and apply it to your trial as will likely result from your control arm as well or from those trials and so just yeah.
Yeah, I think the anything with a three handle on it would probably represent probably a upper limit of what I think our control arm should deliver in fact I think the studies you referring to.
At ESMO War in a healthier line setting I think the Merck study had 60% of patients first line metastatic 42nd line.
It could be a little off there, but our patients or at least second line plus so youre sort of add a line and I think theres good evidence and literature to support that you should expect the signal to actually marginally to cheer rate versus a control them. They reported in that study.
And the other I think you might be referring to the Ace I poster again, which was strictly second line only and again, so I would think.
No on the one hand, it was a retrospective study not a randomized controlled study on the but on the other hand, it was pretty well.
Adopted by an organization that has a vested interest in studying their product pretty.
Closely I think in that setting again, you're talking about a generally on average or perhaps a as healthy or healthier population than the ones that we would have so I think from our standpoint, we would think that again three months is sort of an upper limits and perhaps something around that is what we should see under control arm I'd be surprised that it would be subs.
Actually better obviously, we wouldn't know until we get to the Unblinding.
With respect to the news from the company referred to I think the situation. It does appear to me.
Different and to answer the question directly I know it does not give me any pause whatsoever.
Difference I think is that our safety profile is very very well establish now so the idea is going on a tremendous set of patients to to make sure that we're not doing harm, but perhaps equally importantly, our efficacy data was the basis of a.
Except approval and breakthrough designation dialogue with the FDA.
And once we presented the data wanted matured and it really be capitulated. The early data they saw.
And given that standard of care in this setting is pretty well established I think from the FTC standpoint, our efficacy.
Pretty well documented in our data that we presented in fact, we again as we previously discussed how to label then hand subject to the CMC piece and ultimately all these should result in the CRL.
I don't think their ongoing questions around whether our data warranted accelerated approval from their standpoint, obviously, the FDA has to really have to review the resubmission and it's a it's their preview to purview to take another look at anything they choose to.
That I think is quite different perhaps of the situation that youre, describing where I think the sort of the leading up to the fighting dialogue was perhaps not quite as robust again I'm not obvious not as close to that situation as I am with this one but I think we've had extensive dialogue for submission during the review and certainly since the review with the period of the CRL and I don't think.
One should read into one versus the other having said that once we submit and DFT chooses to ask questions. We'll we'll be ready to answer then again I don't want to speak on behalf of the FDA. So.
I'll leave it at that.
It's helpful. Then one last housekeeping question on the financials. The R&D expense was pumped up pretty significantly quarter over quarter. It is just a run rate there we should apply going forward or were there onetime issues in this quarter that suggest the run rate would be less in future quarters.
[laughter] Selma can perhaps go into details, but I think just holistically on the 100% dropped off and so.
Oh from enrollment standpoint, now we do have ongoing the trial continues until we read out but eventually.
Sometime in the next year or actually will go on some interim standpoint.
That expense will however can stop ramping up on the other had we do have the metastatic breast study beginning to take shape, followed by a couple of new programs that we've launched from a trajectory specifically I don't think we will directly tied to the R&D ramp or change, but somebody is that more color. We can provide.
[noise] Yeah, Phil I think we also discussed is and the flat quarter. There's a number of onetime expenses related to the CRL from this year that we don't expect will carry into the following year.
However, as I've mentioned.
Today, a number of things are getting lumped into the R&D expense given that were pre commercial company, including manufacturing expenses when as it pertains to our clinical development program to your quite familiar that we've ramped that up quite a bit this year or on the manufacturing side. There's a number of onetimes item items as I mentioned in relation to CRM.
Well that will that would drop off and then on the sale than GNS side, you can expect as we move into 2020, there maybe some incremental changes there.
Okay, great. Thank you.
Thanks, Phil.
Thank you.
Coming from the lines of Sean Sean.
From Berenberg capital your line now.
Hi, good afternoon, and thanks for taking my question for you our topic all three solid tumor basket trial, maybe could you remind us what is the cut off.
Top to expression level in non small cell and the with this cut off.
What percentage of patient in second line non small cell can capture and I have one follow up.
Yes, Sean Sean we have not disclose the cut off levels, but it is this study that has gradations of cut offs and we're trying to sort of zero and as part of the.
Colin Doug what would be an appropriate cut off if there is such a thing isn't enrichment strategy that makes sense and did think it's too early to know definitively what.
Portion of the non small cell population.
We expect to capture with the different cut offs, what I would say is that we're very early in the screening and I did mentioned that we had one patient already treated its too early to extrapolate from our.
Internal statistics, what that might represent as a total portion will certainly be able to provide that hopefully in the future quarters as we update and progress on that trial.
Great and also for do you foresee that data you presented at Ash small I noticed that the great three and four especially grid for diarrhea first it's been great actually numerically higher then.
Then that's in the previous triple negative breast cancer patients will hurt too.
I got to ensure positive breast cancer patients.
Our nation for that or is there a difficult.
Conclusion due to the cross talk to comparison.
Thanks.
Yeah, I certainly think the latter applies.
Breast versus you retailer you're dealing with a substantially different age difference between triple negative generally younger ladies.
Feel we're talking about older men.
But I would I'd be hesitant to draw across truck comparisons one thing, we didnt know that as mall was the higher levels of neutropenia versus prior urothelial.
Data that we presented and we're actually looking into that because there was a unusually large geno to pick a enrichments into population that is predisposed to the patient to neutropenia when treated with a you know what you can based agent and.
That is Oh really oddly high proportion I think the numbers quoted was something in the 70, 80% of our patients had that Geo type. It was actually sometimes you have the numbers was close to 50% where you would expect something in the high teens to be more representative of the general population.
But that is the only a sort of anomaly that we intend to observe I don't think we internally salt that diarrhea rates were dramatically different than perhaps it's more cross talk comparison flash small numbers, we didn't have any discontinuations due to diarrhea, which is obviously an important metric to understand the severity of the condition the only discussed.
The nation's more generally due to the neutropenia and that was three patients of our cohort and again, we're looking into this enrichment of the genotype [laughter] extending the higher level that we observed there.
Thank you next question coming from the line of Chris Howerton from Jefferies. Your line is now open.
Great. Thanks, so much for taking my questions I think frankly, most of them been asked at this point, but.
Yeah, I just curious what.
General thinking is with respect to the trip to companion diagnostics and how you expect that too.
Fit into the treatment paradigm in the commercial setting in the future.
Yeah, Chris I'm. Thanks for the question I don't think.
It's really too early to know and frankly, we don't know with trop two enrichment ultimately yields fruits.
Certainly in the breadth setting in triple negative and metastatic.
The are positive hertwo negative setting, we don't expects that the companion diagnostic would be relevant where trop two level generally in breast considered very high almost uniformly to these patients express I have talked to levels that also applies generally urothelial.
In non small cell and other tumor types. We have a reason to believe that it's a perhaps a more heterogeneous population with respect to try to levels and in that setting if enrichment actually does yield better results would we expect to have a companion diagnostic, but it's really too early to know.
To what extent and how that would work can be yet.
Sure Okay, that's fair.
Then you know obviously you disclose that.
Non small cell patients was dosed in that trial any other color you can provide us on the other tumor types and perhaps those did you internally and particularly excited about.
Yeah, Chris a I might remind you that are we designed the study a little bit in making it a two stage.
Trial, where the lead indication non small cell will inform whether enrichment yields beneficial outcomes and after that initial stage would we then expand into two other tumor types head and neck and.
Kind of I think its surgical it's kinda ecological yep.
But that is.
The second stage beyond that would just poly look forward to providing the first cohort in the non small cell update when we reach a meaningful number of patients to talk about got it. Okay. I will thank you for the clarification I appreciate taking the questions.
Thanks, very much Chris.
Thank you next question coming from the line Joel.
Piper Jaffray Your line.
Hey, guys. Thanks for taking the questions or just a couple of quick ones for me. So if I remember correctly at the ESMO event. It sounded like one of the gating factors to re filing was awaiting some last bit of Juicy data. So just wondering if you have those data in hand, now and then.
Would you expect to have one last meeting with the FDA ahead of re filing and if so is that meeting already schedule.
Yeah. Thanks, Joe So with respect to the data it's not so much one last bit of data, but there's just ongoing data that comes in and it.
Goes right into the B.L.A. our project plans are.
Quite extensive and almost down to the day with respect to when data comes in and where it goes and we've had.
Data coming in all along since we started this be writing and the good news is everything has come in as we would've hoped it comes in and we certainly hope that the balance of the data as it continues to come in well well equally be supportive and we have no reason to believe that it wouldn't be a with respect to how long it's going to go it's almost down to the finish line.
And so we've.
The project plan at the time to that we've communicated essentially provide for all the data to be in Q seed and wrapped up cross length, and all the things that need to happen by the regulatory before it gets then you get to push the send button.
It is quite an extensive undertaking.
That happens even on the back end went all the data isn't.
And.
With respect to your second question I apologize it can use the meetings on the left yet whether we're going to have additional meeting I think were ongoing dialogue with the FDA, specifically, we will obviously comment on.
Whether we will have additional dialogue, but I think it's with breakthrough designation your afforded the opportunity to have the dialogue on the other hand, I think theres been a lot of communication already that's occurred in quite a lot of clarity, yes, no. That's absolutely right I mean, they've been enough to make themselves extremely available to us to.
Communicate when we needed to they've been very encourage all the everything's gone well and we will communicate Trinity specifics on individual meetings interactions, but they're available if we need to right now we feel pretty good about where we're out.
Okay. Thanks, and then one one quick follow up here. So what should we expect around your communications to the street around the reinspection, we've seen some some other companies you know.
Relief press release that the inspection has happened and some even have.
Communicated the outcome of that Reinspection, how are you guys thinking about that and what should we expect.
Joe I think.
Talking about specifically the outcome of the inspection is probably a rich too far just given.
Experiencing.
The ongoing dialogue I think you would expect to us to provide meaningful updates in particularly when we file and obviously any decision and anything that happens in between would probably not really be off.
Relevance or importance that would be.
Right and the level that we deem it to be disclosable or necessarily disclose obviously, if there were to occur we would certainly do that but I think.
Giving a play by play would not be something that we'd be all that excited doing I don't think it's all that conventional to do that to be honest with you.
Certainly we will make sure that we do what is appropriate necessary.
Okay got it. Thanks, Thanks again for taking the questions.
Thank you.
Next question comes from the line Matthew Harrison from Morgan Stanley . Your line is now.
Hi, this is from.
Hi, Cyrusone. Thank you for taking the questions.
My first question is following their remarks his question regarding reinspection or do you expect to communicate with investors pre or post the inspection.
Yeah, I think I'd actually exactly the same question sort of trying to answer exactly the same way.
The short answer is no unless there is the material out that we need to provide we would not anticipate giving a play by play.
Okay.
And same question is.
How do you can through report the topic is three study.
Well <unk> would be the first time way on what do you spend so low cat that a response data from that study and a two is I do think there is potential to that traffic to enrich the last label.
Or would you have to wrong disease specific phase threes.
With respect to the timing I think we would look to the appropriate medical venue. We just opened and treated the first patient. So I think it would be really premature.
To talk about when we expect to present that data frankly, we didnt really all depends on how quickly or what the level of trop two.
Patients are that meet the criteria to enroll but once we have a better handle on it will be certain to provide that visibility and it's probably even more mature premature to talk about whether the label what the trial design would look like and what the label what looks like in non small cell I think all of that is really the basis of the study that we're conducting.
In order to establish a whether it makes sense to have a truck too.
Biomarker strategy non small cell lung and the other tumor types that we're looking forward to study that's really premature for us to make any statements beyond that.
Okay.
Thank you.
Thank you.
I.
Yeah No further questions at this time I would like to handy conference back over to challenging for his closing remarks challenging.
On behalf of the entire leadership team I'd like to thank you very much for joining us. This afternoon, we look forward to updating you in the future and the ongoing progress.
That does conclude today's conference call you may now.
[laughter] have agreed.
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