Q2 2020 Spectrum Pharmaceuticals Inc Earnings Call
Ladies and gentlemen, please standby today's conference will begin shortly again, ladies and gentleman. Please standby today's conference will begin shortly thank you.
[music].
Good afternoon, ladies and gentlemen, and welcome to the spectrum Pharmaceuticals second quarter trying to 20 earnings call.
This time, all participants are in listen only mode.
Later, we'll conduct a question and answer session and instructions will follow us it sounds like.
And once you do for assistance during the conference. Please press Star then zero on your Touchtone telephone.
I would know liked it turned to conference or Jerry host Mr. Kurt Gustafson.
Chief Financial Officer, all the spectrum Pharmaceuticals. Please go ahead.
Thank you operator, and good afternoon to everyone.
Thank you for joining us today first spectrum Pharmaceuticals second quarter 2020 financial results Conference call.
Our second quarter financial results press release was sent out earlier. This afternoon and is available on our website at www Dot SPP Irex Dot com.
Joining me on the call today from spectrum Pharmaceuticals will be Joe Turgeon, President and CEO Dr., France, while the Bell Chief Medical Officer, and Tom Riga, Chief operating officer.
Before we get started I would like to reference the notice regarding forward looking statements included in today's press release, just noticed emphasizes the major uncertainties and risks inherent in the forward looking statements that we will make this afternoon.
These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward looking statements with that let me hand, the call over to Joe Turgeon CEO spectrum.
Thank you guard and good afternoon, everyone. Thank you for joining us on the call today.
It's been quite a year already and we're even more excited about what's to come in the second half.
We've made some great progress can and continue to rapidly advancing development pipeline. Despite the challenges up the pandemic and speaking to that I want to thank our dedicated employees I remain focused on the advancement of our clinical development programs. In addition investigator interest in our pipeline remains strong as we pursue new solution.
As for cancer patients.
Or health care professionals.
Let me turn to some brief updates.
Hi programs in late July we announced that Oh is yet another met the pre specified primary endpoint and go or to the phase two seen at 20 clinical trial.
Success of this cohort is a significant achievement for spectrum.
For the patients with this devastating disease.
There is no approved therapy for patients with her to exon 20 insertion mutations and we're looking forward to meeting with the FDA.
Dr. France want a bell our CMO will provide a discussion of the cohort two results on the call later today.
Rolandas our most advanced program is under active review with the FDA for the treatment of chemotherapy induced neutropenia with a PDUFA date of October 24 2020.
Yeah, if approved rwanda's could be the first novel Greenwash I colony stimulating factor available health care providers in over 15 years.
As the PDUFA date approaches our launch preparations for launches are accelerating I look forward to getting back into this market and every year I know well personally.
And the potential of competing in this multi billion dollar growth factor Mark.
Tom Reger, our Chief operating officer lot more to say on this later in the call and then finally, our CFO Kurt Gustafson will go through the financial numbers.
Overall I believe the spectrum is well positioned to drive it's late stage product development aspect for.
And we have the team and the necessary financial resources in place to advance these programs.
We can reenter the commercial arena and achieve our long term goals and with that I want to turnover Dr. French while a bell our CMO for an update on our clinical development progress.
Good afternoon, everyone and thank you for being on the call today, our recent announcement of the positive outcome for coal or do it does seem to 20 clinical trial.
It's an important achievement for lung cancer patient with these mutations and for our spectrum tea.
We are Trilled would this have gone.
It is exciting progress.
There is no approved treatment for patients with her to axon 20 insertion mutation in non small cell lung cancer.
Dizziness, 20 cores to enroll 90 patients and it is the largest prospective multi center trial ever conducted in this patient population with older 70 participating sites in the U.S., Canada is.
Well in Europe.
Patients receive a 60 milligram once daily oral dose of Poziotinib given in a 28 day cycle.
All of the patient and failed at least one line or prior systemic therapy and 60 patients at failed to add more prior therapies, including chemotherapy and immunotherapy.
The primary endpoint was objective response rate as defined by read this 1.1.
Secondary endpoints included duration of response progression free survival and disease control rate.
We intend to treat analysis demonstrated I know, our our of 27.8%.
Do you observed lower bound of 18.9% exceeded the pre specified lower bound of 17% whatever 95% confidence interval.
The data cut off with a median follow up of 8.3 months. Their responses were durable we didn't need you know a 5.1 months with some basin continuing to receive drug after one year.
Progression free survival was five point.
We did disease control rate of 70%.
The safety profile was in line with the type of adverse event scene with other second generation tyrosine kinase inhibitors and was similar to what we saw in quarter one.
We plan to present additional safety and efficacy data for core to at an upcoming medical meeting later this year.
I would remind you that core to what design could be a registrational trial.
We are in the process of request.
He pre NDA meeting with the FDA based on these positive results.
To seek an indication the treatment of patients with previously treated.
Locally advanced or metastatic non small cell lung cancer with early to exon 20 insertion mutations.
Now, let me review, where we are with the additional cohorts and distraught.
Topline results for both cohorts one into I've now been reported.
And we expect to report the results from Coordthree by the end of this year.
Several months ago, we made dosing modification to the other cohorts in the Zenith 20 study.
Our expectation is now one of these new dosing paradigm may minimize dose interruption those modification potentially further in an anti tumor activity.
We remain very optimistic about this program and look forward to updating you in future.
I'll now turn it over to Tom for an update on Rolandas.
Thanks, Francoise, our PDUFA date is just over two months away. We are actively engaged in our commercial build out and we would like to provide an update on the market opportunity and the progress we are making it our preparations for launch.
First and foremost we are ready and look forward to competing if approved.
We are investing a great deal of time effort in research into our strategy and plan of execution.
Let me begin by sharing with you a perspective on the long acting GCSF market.
This market represents a compelling opportunity as it is still a three plus billion dollar market. Despite several biosimilar entrants.
Customers have demonstrated a willingness to change and there remains ample opportunity for a new entrant, especially a novel product like relaunch is.
In addition to the deep market knowledge, we have within the company. We have done a great deal of qualitative and quantitative research to understand what ultimately drives customer behavior.
Let's start with safety and efficacy the phase three program fully launched this demonstrated safety and efficacy that was non inferior to pegfilgrastim in over 600 patients with the primary endpoint of cycle, one duration of severe neutropenia.
Well I Wonder head to head studies were designed to prove noninferiority. It does not mean that these assets are the same.
There are notable clinical differences that will be important considerations for customers.
Severe neutropenia is viewed as a precursor to F in risk and associated complications.
We know that for patients who have severe neutropenia. It most often occurs in the first cycle.
We also know that for each additional day of severe nutra paint neutropenia, a patient's risk of hospitalization increases by 30%.
When looking at the results from our head to head Phase three program launched this was effective at minimizing severe neutropenia in the first cycle.
Additionally, the safety profile was comparable to that of Pegfilgrastim.
The results of our advanced trial are now available and the most recent addition of the oncologist and the results from the identically designed recover trial are now available in cancer medicine.
This data highlights the impact on for a lot. This I neutrophil activity the potential benefit from patients and the value of a novel product in this space. The first in over 15 years.
In addition, a novel product like for like this enables continued development to achieve its full potential.
The details of our preclinical and clinical findings offer a platform to enhance customer awareness prior to launch.
There are 19 articles, an abstract published or presented your peer reviewed across a range of scientific forums.
Additionally, our development program had over 100, U.S. sites, which increases came well familiarity with the products clinical profile.
Furthermore, we continue to invest in this asset and maximize its potential as a novel product. We recently announced the initiation of a trial looking at really want this in the same day as chemotherapy. We believe were lots is maybe uniquely suited for this type of administration and we are excited.
To learn more.
And we look at the market today, we are seeing important developments, although there are several bio similars available there competing with rational pricing.
There is a perception that bio similars, our offering deep savings to customers in the health care system.
However, the data suggests something different.
Despite a significant difference in list price the current pricing in the market reflux and much less variation among competitors.
Based on average selling price or Asap, which is a better measure of true market cost and list price bio similars are only offering a discount ranging between zero and 8% person last.
There's also a perception that the Lewis.
Ken will dominate the market.
However, what we have seen to date is that the lowest price does not dictate share.
Currently the bio similars represent approximately 27% of the overall market.
Within the Biosimilar space, one product come in 74% of the business and has consistently been priced at a premium to the other bio similars by an average of 5% since launch.
If this market we are behaving like a typical generic market one would expect it the first entry and the lowest price product would command higher share. However, we're clearly seeing that this is not the case, suggesting that the long acting G. CSF market is still behaving as a brand driven market.
Okay.
These pricing dynamics, along with CMS coating and reimbursement changes provide an opportunity for a novel product like Middle office.
Well want this will have a unique J code that allows for unilateral control over its total reimbursement.
The reimbursement for bio Similars is a function of the innovator price in this case neulasta.
This ties them together and creates a pricing dynamic, which they can't control on their own.
It also causes a lack of predictability for customers in a high utilization drug category.
On the other hand with Romano, Yes, we will have total control over our pricing decisions, which will offer customers stable and predictable reimbursement.
We will be able to act independently with regard to discounts and rebates to manage reimbursement through and through SP without reference to an innovator product we see this as it as a competitive differentiator.
As we look at the customer landscape. There are really three t. segments clinics threeforty be hospitals, and non threeforty be hospitals.
Each of the three segments has unique characteristics to consider.
Most notably the clinic segment reimbursement largely influences adoption and this segment is responsive to tailored contracting.
There's a strong value placed on ASP stability and predictability along with high utilization of patient access and support programs. We are intimately aware of the differences by segment and have a tailored strategy that enables us to compete across all of them.
Pairs are also playing a very important role in this market and we are actively engaging them.
Through this engagement, we understand that the majority of the time providers still hold the decision making power.
That being said payers are undoubtedly increasing their influence in this market and our team is ready to partner to ensure a lantis isn't available option.
Regarding the commercial team, we have begun to build a competitive in fully integrated commercial infrastructure to support the launch of responses.
Our team has a deep understanding of oncology and supportive care.
Once fully staffed we will have a team of approximately 60 commercially focused ft ease within sales access and reimbursement marketing commercial operations and medical Affairs. We currently have 21 of our team members already onboard.
In closing we are ready to compete we have all the ingredients to do so and we look forward to the PDUFA date in October with that I'll turn the call over to current to review the financials.
Thanks, Tom.
RST any expense for the second quarter of 2020 was 14.7 million versus 17.2 million in the previous year.
R&D expense was 21.7 million versus 17 million.
The increase in R&D expenses relates primarily to purchases of real lantis drug substance as we prepare for the launch of this product as well as higher clinical costs associated with Posiet in clinical trials.
We expect to make additional relaunches inventory purchases in the third and fourth quarters of this year.
Recall that the accounting rules require us to expense this inventory as R&D expense until the product is approved but when we actually sell this inventory it will be reflected at a zero cost of goods.
Our net loss for the quarter. It was 32.1 million versus 28.4 million in the comparable period in 2019 and on a non-GAAP basis, which primarily backs out stock compensation costs or loss for the quarter was 31.8 million versus 25.2 million in the prior year period.
The overall change in cash and marketable securities for the quarter was 21 million.
Operating cash burn, which is a better measure of our actual cash outflow was 27 million for the second quarter.
This is consistent with operating cash burn in the last few quarters.
We ended the quarter with $157 million in cash plus marketable securities just cash balance does not include any of the proceeds from our financing in late July that rate, a net $82 million after deducting commissions.
This amount is a combination of the proceeds from our underwritten public offering and sales under our ATM facility, which we utilize the day after we announced the results from cohort two.
If you were to add the 82 million to our Q2 cash balance we would have a pro forma cash balance of $239 million.
This provides us with plenty of runway to continue the development and commercialization of our late stage assets.
With that let me hand, the call back over to Joe.
Thank you garden. Thank you Tom Thank you Dr. Franz swap.
I think he gets cheaper everyone's remarks at spectrum continues to make outstanding progress on our pipeline and our commercial build out in anticipation of potential approval and launch for roll office I'd like to thank our entire team for their hard work dedication the unprecedented times and with that I'd like to open the line for questions operator.
Good up on open up the lines for questions I'd appreciate it.
Thank you at this time I would like to inform everyone in order to ask the question. Please press star one on your telephone keypad again, that's as far want to ask question.
We have your first question from Molly Red Cross from Jefferies. Your line is open.
Hi, everyone a congrats on the updates and thanks for taking my questions. I think you guys have been asked as on other calls in a couple different ways, but.
Just for pose YOD, they wanted to dig into that a pre specified a 17%.
For a little bit more again, and so I'm wondering if you can provide more background and thoughts on the assumption that went into that pre specified 70% or our number for posey and how this was established would that be a.
Sure well, yeah, Moray a good a good to speak with you so.
The discussion obviously derive from Oh reviews, the literature and as you know there's no approve.
Drugs for heard who.
Next on 20 mutation, but there is a number of reports in the literature, giving us some guidance now in large part. These are the data tend to literature is ER is usually small number of patients retrospective analysis are very small number of base.
In our one side et cetera. So that's how it was arrive after reviewing a this information.
There was a discussion with the FDA.
And then you know various the calculation more establish as the that what would be our pre specified endpoint, obviously communicated with with the FDA and eventually finalized in a statistical analysis plan.
So that's I hope that answers your question and you know you probably will Alaska was that the early to one specific for her doing the answer is yes. It was.
The literature is a little different than dgs far data.
Got it yeah, that's a tough for additional perspective.
And.
And then we're guessing that after you will likely want you to resolve some of the differences in data that you're seeing in court one versus core too and you guys talked about this on the last conference call I sort of the ideas on how you could resolve this.
With explanations so I'm just wondering if.
I guess, how are you thinking about this and is there a plan in place to address some of the difference is that you're observing between core wanting core too in the pre NDA meeting.
Yeah, you're absolutely right. We obviously expect that a you know will need to provide some.
Explanation rationale to explain to result in as I've indicated I think last time. The August one is that there's a different receptor a player. We don't think that that's necessarily the main difference.
We believe that a the investigator.
Gain experience with the drug by the time, there we're doing in enrolling patient into your two so that could explain in part as some of their resolved a there's ongoing analysis here. So we're looking for you know our their country difference investigators side their friends et cetera.
You know the use of concurrent medication. So all of those factors are being looked at a as we speak or you know there's possibility that a number of side and you know core to coming from any particular region could be different.
Comorbidities I mentioned, so all those factors are are being analyzed and ER and we intend to present that information obviously to the FDA.
I hope that answers your question.
Yes, yeah that does that I think that's that's good I'll stop there. Thanks for taking my questions here.
Thanks Mark.
We have your next question from RBC Your young from Cantor Your line is open.
Hi, guys just really on Felipe.
Well take your call I'm, just a follow up for.
Hmm can you give us any sound puts a similar situation, where it's Rob I'm sort of working one cohort, but not any other.
The outcome and maybe just talk about what kind of preparation and analytical work are you currently doing try do you know sort of trended association to that day.
Yeah, I mean, I am I off the off the cuff I can't give you an example, but but I think potentially more importantly, you've got to recall that we had.
An agreement with the F. did that and we've communicated that to a two the street that all although our for a core <unk> independent of one another's. So what that means is that if one is positive and the other one is negative that's fine that that was a tough.
Taking into account and as I've indicated there's a number of reason that we're looking into two explain those difference. So you know given that it was the.
If you want a.
Three.
Way.
We think we're in reasonable shape and that the fact that the EG fr. One did not quite meet the endpoint or should be acceptable to the F.D.A. I want to remind you, though that we had seen you know a clinical activity. There. So it wasn't kind of there was no active.
Do you need you have far.
It did not reach the required response rate that we had pre specified but there's certainly was evidence of a of an active drug there.
Okay got it and down is there any hypothesis around whether it might be easier or harder to see maybe more activity in our frontline patients <unk> yeah.
Actually patient.
Yeah, the and you know we have indicated previously that the bar in first line is higher weve not disclosed the bar and if you look at the literature that I think that's pretty well accepted that in first line patient or you know a respond better.
For two to these drugs you know in part, possibly because they have more bone marrow reserved they have generally better protoplasm meeting their liver and kidney all their oregon's there are in better shape not having received.
Multiple rounds of eatery chemotherapy or.
There have forms of therapy. So we would expect give first line to probably perform better but the bar for our pre specified endpoint is also a little light.
Got it thanks guys.
Sure.
Thank you we had.
We had your next question from at White from H.C. Wainwright right. Your line is open.
Hi, guys. Thanks for taking my questions.
So maybe one last one for me on.
Imposing.
You know when you discussed the data from the cohort one patients, 88% had dose interruption and 68% had dose reductions.
And your thoughts going back in revisiting that patient cohort.
I know you're with a different dosing schemes that you're trying out to try to get the patients just to stay on there and address these second line and third line patients.
And then I have a follow up question.
Sure So Uh huh.
You know you've got a [laughter] you got a good memories. So when it would be the only guidance we have given because you know the analysis in core do right now is ongoing but we've indicated that the number.
You know the side effect profile, a was quite similar to core it's one and inline with the class. So we're obviously looking at that and as I have suggested in my prepared statement. You know we were anxious to look at the data.
Oh and get more data looking at different dosing, meaning are you as you probably remember we have a cohort that 10 milligram or sub gord I should say 10 milligram 12 milligram.
And six then they'd be I'd. So we look forward to get that data.
Given the asked life and given the modeling we did we we anticipate that we should be able to improve or the tolerance as well as potentially the anti tumor activity. So unfortunately, that's all I can tell you today and we look.
Look forward to getting that data in near future. So that we can oh share with you these new results.
Great. Thanks transfer inter switching gears I had a question on that.
Platform, you haven't talked about it in a while I'm just wondering if you can give us an update on phase one I think that said you were looking at up to 20 patients. There I'm just wondering with co badge, if you've had oh, the enrollments going there and you know what we can expect a seeking to fit platform and also if theres now that you're.
I have this.
Increased cash on the balance sheet, if there's other BD opportunities you're thinking about pursuing thank you.
So let me divide your question into a first of all fit a as you as you can imagine we're heavily focused on ensuring that the question at the F.D.A. as for us on Relaunches or address in a high priority as the way.
Well as a now the focus on posey and getting to a pre NDA meeting and.
Hi, conducting a numerous ER analysis, so that we have a good meeting.
The fifth program continues or it has been impacted.
Like some of our order program by the pandemic.
And Oh, we hope to give some additional guidance I'm you know before the ended the year, but we are at this point I don't want to a adventure in.
In that area right now other than to say our late stage programs take priority, we're making progress.
But I can't or won't give any further detail today about fit.
Add I'll I'll answer the second part.
Certainly Tom and his team extremely active BT business development program. So not a week goes by that we're not looking at different assets that makes sense for.
For our company moved the company Forge so absolutely we're doing that on a very aggressive basis.
Great. Thanks, a lot show.
Sure.
We have jump on next question from Michael Schmidt from Guggenheim Your minds open.
Hey, guys. Thanks for taking my questions I just had a follow up on the hurting US study cohort two I guess how are hurt too.
Excellent 20 mutated patients treated today, a that standard of care and you now or are they treated differently. Then you know what time I guess lung cancer patients are treated.
Yes, so as you know there's no approved treatment there is a various guidance a that's been provided in general are these patient usually see in second line or in first line, we received a combination of chemotherapy what.
Often or whatever checkpoint inhibitor and or a triple combination of chemo in early two immunotherapy with checkpoint. So we have now provided.
Information about the he should make up in our study, but it's quite difficult to what is seen in use in.
In treatment of those patient in second line.
Okay, and what did you know about that the prognosis is all of those patients.
You know all comers non small cell lung cancer patients.
Yeah, So a D D.
As I said then in one of my earlier remark. There. There there is no approved drug the literature is sparse, but ER is Sears and you know not a uniform if you want.
There are depending on what the study you look at or data that was published.
If you look at relatively large.
Multi centric data that was put together or there is a good to consortium, there's the U.S. consortium and a European consortium that I've looked at this and a in second line. Obviously, there was some variability, but you're looking at something in the mid.
Teens, usually for a response rate I think the data in the literature overall, though does confirm that.
Patient, what exon 20 mutations or to have a worst prognosis then wild type.
Okay. Okay. Thank you and.
Well, thanks for clarifying that and then maybe just well along to.
A couple of questions. There I guess number one you mentioned that although the good luck demonstrated non inferiority compared to last or there are some some differences and I guess my questions.
How how effectively when you'd be able to you know news release those differences in your marketing efforts to a you know to achieve a formulary placement.
And contracts.
Yes.
Well I'll take that one thanks for the question. So the studies are designed to be non inferior the package insert will have.
Non inferior indication.
Public domain, it's available the differences in our publications or Medical Affairs group will obviously have those are in response to questions. So it's in the public forum. The results of the study, but our based expectation is that the label will be a noninferiority labeled coming out of the.
Okay, and I do think when when the label is available you'll see a if approved that non inferior does not show identical nature I think when you think about a biosimilar in the 351 can't pathway. There are not head to head studies. The products are not novel, So those nuance difference.
The clinicians will ultimately evaluate or not there and in that pathway ability pathway will have that and ultimately that won't be represented in the in the product labeling.
Got it and then I think you know a lot of its obviously comes down to two contracts and so on I guess you did mention that line comes well obviously you have on a code J code said.
Maybe just help us understand a little bit better or how that.
Could be an advantage, maybe compare to or not the or neulasta biosimilar us in terms of access.
I think it comes down to predictability of average selling price. So I think in these high utilization drug categories customers are looking for an element of predictability and when reimbursement is interrelated between multiple products that causes a bit of uncertainty.
And I think having a novel products that are reimbursement is not impacted by anybody else's behavior on in this case, the innovator product. It enables us to unique position to provide a level of stability and predictability of our average selling price. So when you have.
Drug category, that's among the top two or three within.
Of pharmacy budget or a community oncology budget and you have.
Something that enables predictability and stability of average selling price. There's just a number of advantages that it helps analysis long term planning. It helps what do you know what to expect and you have a reliable partner that you see.
Is bringing a value proposition that you can you can have overtime and I think that I think thats the real key.
Okay. Thanks, and then one last done on market dynamics, I think and.
Said recently that on well as.
You know is holding up and you know I think over half the Mark is actually on pro and.
It's competitive.
Segment would be the I guess, the you know.
Traditional long acting Tcs asked I guess you have any for use on on how the market's broken out right now and what are your.
Competitive because they then.
Our full intention is to compete across the board you stated it correctly on pro does represent about 50 plus percent of the market and I think we're going to challenge. The premise if that's stickiness based on clinical value or if that's just based on home game theory in contractual value. So I think.
Thats yet to be determined.
If you look at the uptake of bio Similars I think it has taken share from both the Prefilled syringe as well as on pro but I think this coal the dynamic, especially in the second quarter. It provides an additive <unk> added advantage. We're on pro just given the limited office visits but when we.
When we if we're fortunate enough to be approved in October we look forward to challenging the premise across the market, whether it be bio similars or the innovator regardless of administration vehicle, how we could how we could compete.
Yeah, I'll add to it if you walk down memory Lane and watch when the approach first came out it took a long time before I get it got marketshare and I can tell you that when it got market curious when he added a 2% discount on top so it's really it was driven by the discount that was the motivation.
That the offers practice managers and the doctor saw in the clinics and that so at the you know it didnt take off at the beginning I'll remind you.
Okay, great. Thank you so much and thanks for taking my question.
I guess.
We have your next question from my Yacktman tiny from B. Riley SPP. Your line is open.
Hi, Good afternoon, it's it's all on for Mike Congrats on the progress. So just to a brief question from US I mean, most of our questions have been addressed but just wanted to 'em got some color on the cohort for enrollment and when you.
We expect to have kind of initial data there even a preliminary look into that sort of B.I.D. dosing strategy and maybe I'm in the context, the the engagement, you're having with the FDIC and the cohort two filing I'm missing something you'd have prior to that meeting.
<unk>.
Sure. So the a I think we've been thinking that [laughter] or four was ER roughly.
I've been role and we have also indicated that we modified the balance of the patient to be I'd dosing.
So that was announced previously recruitment as I indicated before has been impacted a little bit.
By a different cohort that different pace there by the pandemic.
And though we certainly anticipate that a we will be discussing.
Some of the preliminary information we have on that particular cord given that it's the same receptor as cold War.
To that we would expect that DFT it whatever questions. Obviously, we're.
Looking at data, it's an open label study and we will look at it ER. So that we're in a good position to discuss with the FDA.
[laughter].
Great and then maybe just a brief follow up but can you remind us of the timelines around that a few engagement for cohort two and need sort of 60 day lag time between the PDUFA.
Yeah. So we're actively working on.
Repairing augmentation you know the process is that you request a pre NDA meeting and if the a ft. A grant you that eating basically the clock starts and usually they meet with you would in 60 days. So by the time you submit their requests you kind of have to know that.
You're ready to adapt to the discussion you have to provide them a briefing books. So we're actively working feverishly on putting the briefing book together. So we anticipate requesting the meeting in a very near term.
Great really appreciate the color and congrats once again. Thank you guys. Thank you. Thank you.
I'm showing no further questions at this time I would now like to turn the conference back to Mr., Joe Turgeon CEO, Sir Please continue.
Thank you operator, and I like to thank you all for your participation in the call today I really appreciate your interest in your question.
Spectrum pharmaceuticals, and well be participating by the way in several virtual health care investor conferences coming up here in September and we hope to connect with many of you at that time, we certainly will now an interim if you have any further questions or need any additional information please feel free to contest.
Yes in between and went that listen thanks for interest again, how great I afternoon, everyone. We appreciate it.
Ladies and gentlemen, this concludes Denise conference call. Thank you for your participation and have a wonderful day you may all disconnect.
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