Delcath Systems Inc (DCTH) 2010 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Delcath second-quarter 2010 financial results conference call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference will be open for questions. (Operator Instructions).

This conference is being recorded today, Thursday, July 29, 2010. I would now like to turn the conference over to Mr. Doug Sherk. Please go ahead, sir.

Thank you, Operator, and good afternoon, everyone. Thank you for joining us today for Delcath Systems' second-quarter 2010 financial results conference call. A replay of the conference call will be available beginning approximately one hour after the call's conclusion and will be available for seven days. The operator will provide replay details at the conclusion of today's call.

This call is also being webcast live by the Company's website at www.delcath.com. And the call will also be archived on the Company's website for a limited time.

Before we begin, let me quickly reference the Private Securities Litigation Reform Act of 1995, which provides a Safe Harbor for forward-looking statements made by the Company. Today's call may contain forward-looking statements which are subject to certain risks and uncertainties that could cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to the Company's ability to successfully complete and submit the new drug application to the FDA; acceptance by the FDA of the Company's clinical trial data and NDA application; the Company's ability to secure regulatory approval of current or future drug delivery systems in the United States in foreign markets; the Company's ability to enter into agreements with foreign partners and the corresponding revenue associated with such foreign markets; actions by regulatory authorities; changes in the healthcare environment, including reimbursement and overall economic conditions and uncertainties regarding the ability to obtain financial and other resources for any research, development, and commercialization activities.

These factors and others are discussed from time to time in filings with the Securities and Exchange Commission, including the Form 10K for the fiscal year ended December 31, 2009, which was filed on February 26, 2010. You should not place undue reliance on these forward-looking statements which speak only as of the date they are made. The Company has no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

For today's call, we have encouraged investors to submit written questions through noon Eastern time today. For those of you who did submit questions, we appreciate your participation. Management has attempted to answer many of your questions in their remarks. Following those remarks the call will be opened up for the live question-and-answer session, and time permitting, we will also try to answer all the written questions not already addressed.

We request that each participant during the live Q&A session limit themselves to two questions and then re-queue to ask additional questions. We thank you in advance for your cooperation with this process. Given management's schedule, we have allotted one hour for today's call.

Now, I'd like to turn the call over to Eamonn Hobbs, President and Chief Executive Officer of Delcath Systems.

Thanks, Doug, and good afternoon, everyone. Joining me this afternoon are Dave McDonald, our CFO, and Kris Kandarpa, our Chief Medical Officer.

I would like to start off by thanking those of you who submitted your questions for today's call. We look forward to answering as many of them as time allows today.

Since we last talked with you on June 15, our team here at Delcath has continued to execute our strategy to complete the development and gain regulatory approval to market our chemosaturation system for percutaneous hepatic perfusion or PHP. In today's call, in addition to discussing our second-quarter financials, we'd like to update you on the progress in regulatory affairs, clinical publication, and recent additions to our Medical Advisory Board and our Board of Directors.

Since the presentation of the Phase III trial data at ASCO in early June, we have received consistent, positive feedback from clinicians about the data developed from the trial. The highly successful trial results, showing the benefits of the chemosaturation system for PHP for both those patients that had treatment from the start with the PHP system as well as those that crossed over from best alternative care, were reviewed during a call we conducted on June 15.

Work continues on a submission of the trial's results to a top-tier peer-reviewed medical journal, and we are hopeful that such a submission will be completed during the fourth quarter of this year. Assuming the submission is accepted, we are optimistic that publication of the trials data will come in Q1 2011.

Our team also continues to prepare the remaining four modules of our FDA submission. The first module, which was the Phase III trial data, was submitted in late April. The remaining four module tools are scheduled to be submitted on a rolling basis to the FDA. We expect that the process will be completed in the fourth quarter with October remaining as our target.

If the FDA accepts the submission, we would anticipate approval to market the chemosaturation via PHP system in mid-2011.

For Europe, we are on track to complete our Class III medical device [CE application], quality system and GMP audits and submit our technical files by the end of the year. As we prepare our FDA submission and CE Mark application, the various regulatory bodies will be conducting quality systems and facility audits of our Queensberry facility as part of the review process. We expect to be fully prepared for the auto process which will take place this summer and fall.

During our partnering initiatives for the Asian market, we continued to conduct negotiations with potential international partners. And as we noted back in June, the interest in our technology increased, subsequent to the ASCO Phase III trial data presentation. We will announce any developments as they occur.

Many of you have asked us about the status of our Phase II trial at the MCI. The trial is still ongoing and our intent remains to close the study soon and submit for publication prior to the end of the year. Recently we were able to attract five distinguished physicians to join our Medical Advisory Board. Joining the Delcath MAB are Dr. Yuman Fong of Memorial Sloan-Kettering Cancer Center; Dr. Jeff Geschwind of Johns Hopkins University School of Medicine; Dr. John Kaufman of the Dotter Institute of the Oregon Health and Science Center; Dr. James F. Pingpank, Jr. of the University of Pittsburgh Medical Center; and Dr. Jonathan S. Zager of the Moffitt Cancer Center.

One of the MAB's missions is to abide away potential applications of chemosaturation via PHP therapy in new cancer indications. With these additions, our MAB now consists of 10 leading clinicians on the cutting edge of oncology research and treatment. We look forward to their guidance and expertise as the Company begins to transition from development stage to commercialization.

We also recently announced a transition on our Board of Directors. We are very pleased that Doug Watson, a former President and CEO of Novartis Corporation, the US subsidiary of Novartis AG, agreed to join our Board. Doug brings extensive experience in pharmaceutical and pharmaceutical industry. He currently serves as the Chairman of the Board of OraSure Technologies, as well as on the Board of Biomimetic Therapeutics, Dendreon Corporation, and Genta. We look forward to his contributions to Delcath.

Additionally, we would like to thank Rich Taney for his service to the Board. Rich served as CEO of the Company from December 2006 through July of last year and, while he is stepping down from the Board, we are delighted that he will continue to serve as a consultant to senior management and the Board of Directors.

Now I would like to turn the call over to Dave McDonald, our CFO, who will review our financials. Dave?

Thanks, Eamonn, and good afternoon, everyone. As many of you know, we filed our 10-Q report for the second-quarter results this afternoon, and I am happy to report that our balance sheet remains very strong. The cash position as of June 30 was approximately $27.2 million and we continue to have no debt. During the three months ending June, our cash burn, our monthly cash burn was approximately $2 million per month.

Turning quickly to the income statement, we reported an operating loss for the three months of $8.3 million. Now it is important to note that approximately $1.6 million of that was related to non-cash charges basically FAS 123 for stock compensation expense. Given we were adding a number of people and stock prices was rising, that non-cash charge was higher than what we were anticipating at the beginning of the year.

As we continue to move the organization forward, research and development expenses increased about 109% to $4.6 million. That said, reflects additional headcount as well as spending on our FDA submission. And included in the operating expense was a one-time purchase of raw materials of approximately $600,000. Again, it is important to note that as a development stage company, all of that gets expensed. It does not go on the balance sheet as inventory.

So with that brief update, I would like to turn the call back to Eamonn.

Thanks, Dave. Before opening up the call for questions, I'd like to remind our audience that we will be presenting at the Wedbush Securities Life Sciences Best Ideas Management Access Conference in New York, New York on Tuesday, August 3 at 3 PM Eastern time. We are also presenting at the Canaccord Genuity Growth Conference on August 12 and we will announce those details soon. Both events will be webcast.

Operator, we are now ready to take questions from our telephone audience.

(Operator Instructions). Ken Cacciatore with Cowen and Company.

Thanks for the updates and, also, congratulations as you continue to bolster the clinical and scientific strength. I was wondering if we could talk about, as we are getting closer now to commercialization, maybe some of the steps you are taking to bolster the commercial infrastructure. And that's just one part of it, and I know you touched upon the manufacturing. So maybe just a progress update on the commercialization strategy and what you're doing.

And also, maybe if you could give us a little bit of sense as we get closer about pricing decisions. Maybe discuss with us a little bit of the homework you have been doing more recently, thoughts about your pricing, maybe, like I said, work you've been doing in that regards, maybe some initial conversations with payers to give us a better sense of what is happening there as well.

Sure. The programs we have going on right now in commercialization are pretty extensive. Our plans in the United States are to go direct, have a direct sales force that we will be starting to put together in the first half of 2011.

We've already built up a sales and marketing organization from the top down. Augustine Gagou was our Senior Vice President of Global Sales and Marketing, and he is actively putting together his team. We have already built up a strong infrastructure of a marketing team and we will continue to expand that team as we grow closer to FDA and OUS regulatory approvals.

Our plan in Europe is to go through stocking distributors with a few countries where it makes sense going direct. So Augustine and his team has (sic) been working on putting together the distribution network for stocking distributors in various European countries. And we feel very comfortable that those will all be onboard prior to CE Mark approval, which we anticipate around mid-2011.

And Asia, of course, we are working on strategic partners who will also be our exclusive distributor. And our intent is to have very close partnerships in the major markets there. We have already set up our first one in Taiwan and are very actively pursuing and negotiating deals in China, Korea and Japan.

So the pricing, moving on to pricing, our anticipation is that our average selling price for modeling purposes for the Delcath system in the United States would be $20,000. And that would include both the drug melphalan and the drug delivery system, which is still regulated as a (sic) under the drug approval and drug labeling.

And why we believe that's a good number to work with is we've looked at comparable treatments for liver cancer, and feel that a list price of approximately $100,000 for an orphan drug is a good rule of thumb for a treatment course, and factoring back into 2.5 treatments per patient, we think that the $20,000 average selling price is a very conservative estimate for modeling purposes.

OUS, it varies whether we are direct or through a distributor and varies by country. But the average selling price will -- and it may or may not include the drug. So -- again, depending on the country. So that one is a little more complex to model out, but we would expect that we would have still very attractive margins, even in -- gross margins, even in through a distributor network.

And last with regard to payers. We continue to work on our plans for reimbursement. We still get feedback from the clinical sites that there are existing codes which, they believe, will provide adequate -- at least adequate reimbursement to make the procedure attractive. And we are preparing to get -- as a backup plan, just in case that does not prove to be true, we are certainly prepared to get our own codes.

But at this stage, I think it looks pretty clear that existing codes will be what is used at least initially.

Matt Dolan with Roth Capital Partners.

Good afternoon. Maybe first question on the spend in the quarter. Did that ramp as you went or can you just talk about kind of cash usage and expenses here as we go into the second half of the year and into the commercial phase?

Yes and, obviously, monthly it will fluctuate depending upon what hits. So if you looked at the first couple months of the quarter's consistent with the [1/8] that we had been saying for the last eight or nine months. And then it was higher in that third month of the quarter, largely because of that one time spend on raw materials.

So that said, obviously we've got more people ending the quarter. I think we ended the quarter at about 30 -- 32. So and I think sitting here today we are at 38 or 39. So as we've said, we anticipate as we get closer to commercialization, headcount will continue to go up and burn will move north.

Okay. That helps. And then, just thinking back to the data that came out at ASCO, can you maybe just, Eamonn, your anecdotal feedback from talking to physicians and that could be potential customers out there. You know, what is your perception of how the data was received, how they expect labeling might proceed with FDA and has your confidence level increased, decreased, or remained the same out of seeing that full [bid assess]?

I would definitely say our confidence level has increased. You know, with the amount of noise that was associated with the ASCO presentation, we certainly went -- we did a deep dive into our database and a deep dive into our future customer base to make sure that all our channel checks were still showing the same.

And we came away from that really very, very comfortable. Even more comfortable that we have a very robust trial with excellent data in that our market assumptions were validated and we -- being a marketing guy, the way to validate markets is to talk to the market and ask them what they're going to buy, and how much they are going to buy of it and will they associate a value commensurate with a price. So we are constantly doing that and -- because it is a moving target in any market. But we've been very pleased with the validations that we continue to receive.

On a scientific level, Kris is here. Maybe he could comment on that.

Sure, yes. As far as our clinical friends are concerned, they are very excited by the results be they medical oncologists or surgical oncologists. I just got back from the European Congress of International Oncology, and we had a workshop there that was very well received and a lot of interest in our booth at the show.

Okay. Great. So kind of a follow-up on that, then, your perception now relative to ocular and cutaneous patients is that surgeons or physicians will adopt for those applications kind of regardless of labeling with the FDA?

Correct.

Okay. And then finally, Eamonn, you mentioned an increased level of international partnership interest out of ASCO. Does that --? Maybe you could just help us bracket the timeline of an agreement. Have you progressed in those discussions or what type of milestones should we look for that might hint at one of those agreements coming?

These agreements, you know, as the recent history has shown, are very, very difficult to time. We believe we are making very, very solid progress on multiple fronts and we are extremely optimistic. But they are not finished till they're finished and we're -- and no one will be more pleased to announce a deal than I will be.

But we'll -- I couldn't -- I couldn't -- I couldn't -- I wish I could venture a realistic estimate as to when we'll have one of these close, but it is very steady progress on multiple fronts. Very, very serious interest and some very consistent interest. So we're -- you never want to count your chickens before they're hatched, but we are optimistic.

Great. Thanks for the time.

Brooks West with Craig-Hallum Capital.

I wanted to push just a little bit more on reimbursement. You know, you're talking about adequate existing codes. Are those the IHP surgical codes that you're referring to? And I'm wondering as you -- you know, obviously, it is early days in the process, but as you look out to commercialization, anything else you can talk about in terms of the environment? I'm thinking about even what's happened to Dendreon with the national coverage analysis out of CMS. Just any other detail there would be great.

Sure. The codes that exist that can cover our procedure are numerous. They -- including the surgical IHP, but it is much broader than that. And depending on facts and circumstances, different codes can be used.

We are putting together that menu of codes that we're getting through surveying hospital customers to nail it down. But it isn't as simple as there is just one code. It's a whole list of codes that can be applied in varying orders to be the most appropriate for the facts and circumstances of each individual patient.

They are -- these will be at least at the beginning inpatient procedures, so there's DRGs, and -- you know which are pretty global in their scope and they are very high, reimbursing.

Okay. Let me -- let me switch to Kris. Any update on the filter program and we were talking around ASCO. You know, maybe a next-generation filter might be able to completely remove melphalan prior to depositing the blood back in the body. Any update there?

Yes. So we do have our R&D facility up in Queensberry and we've started working on different media codings and filter housings. And we are, I think, on track to having a preclinical filter by the end of the year.

And is that still the thought that you should be able to improve on the removal of the drug?

Yes, what I think it does if you do that, it allows the physicians, gives the physicians a lot more options to go after other lesions elsewhere in the body with far fewer systemic toxicities.

Okay. And --.

And one thing to add to that, because I can imagine that it might come up and that is from a regulatory perspective, we are going to seek approval for what was used in the clinical trial. And then seek approval, post-FDA approval of what -- of the system that was used in the trial which generated all this great data. We are going to definitely be pursuing approvals of supplement -- or of improvements on the system in a normal and customary supplement fashion with MDA supplements.

So, we are not trying -- we are not mixing apples and oranges in our initial submission. So which is the right way to do it.

Sure. Good. Thanks. And I guess just last question, Dave or Eammon. I am frequently hearing from people, since the breakdown of the stocks in [SASCO], you know we haven't seen any insider transactions. Has the window just been closed for you guys? Any detail there would be great. Thanks.

This is Eammon and then I will let Dave speak because he has more control over the window than I do. Because I'd like to see the window open all the time. But clearly you've hit the nail on the head. Speaking as one insider, we've -- I've been very frustrated in not being able to buy because the window has been closed. And the decision on whether the window is open or closed is impacted by timing issues, as well as a committee of our CFO, Dave, who will get to speak, ahead of our audit committee and Peter Graham, our internal counsel and outside counsel, as he sees fit to bring in.

So, yes, they are [in]. There's a lot of interest, but we have not had a window since ASCO. And over to you, Dave.

Well, thank you very much. Yes. Well, I'll confirm there has been no window since ASCO. And, as you know, Brooks, you get your normal quarterly periods around the results where they are closed. And we take a fairly conservative view on that for development stage companies as well as then, if there are any pending things that could be material.

So -- and we've been in the closed window, given the Q2 results, since just after ASCO.

So just to follow up there is when might we see that window open up?

Can't comment on that, but good try.

Yes, the -- obviously, if there is any material non public information going on, then we can't open a window. So I think I might be frustrated for some time to come.

Yes. But as you can imagine, given the stage, [right], there are a lot of things going on and as we continue to have discussions and other developments. It's just -- and they're all good things but it is what it is and, therefore, it's sometimes a little frustrating from our standpoint that we can't take advantage of what's gone on. But, there you have it.

Okay. Thanks.

Jason Mills with Canaccord.

This is [Jim Morris], and I'm calling in for Jason. I just wanted to follow up on the feedback that you've been getting from physicians. You said a little bit in the beginning about how it has been positive, but it can't be positive for all of them. Some of the guys that are pushing back, what has been their concerns (sic) and how are you addressing those?

Frankly, we have not gotten a lot of pushback. We've been going through our channel checks vigorously, and the issue that was presented by the discussion at ASCO about overall survival -- you know, the channel checks we keep getting very consistent feedback on was -- that while the trial was never designed to provide robust overall survival data because of the crossover provision. So, actually, there's just no negatives in that trial associated with overall survival. And it's not fair at all to say, well, the trial is flawed in some way, because it didn't provide overall survival data because it was never intended to.

And then, coupling with that the context of an FDA approval, the trial is being conducted under a special protocol assessment that clearly specified, called straight out, that the overall survival data would be confounded by the crossover provision. So we -- speaking for me, I haven't gotten any negative feedback. How about you, Kris?

Yes. You know, the physicians understand the study design and they also understand the details of the criticism. They've discounted it entirely because it was not at all relevant to the present discussion of our study. And so, to echo Eamonn, I've not yet gotten any pushback per se from physicians to defend anything.

You know, the only -- I'm just searching my memory banks. The only negative feedback that I can remember over the last six months before ASCO and after ASCO, was associated with an incomplete understanding or a complete misunderstanding of what we were trying to do. And maybe that's worth discussing a little bit, in that some medical oncologists and other specialties as well, didn't quite understand that we were -- what we were trying to do in that we were trying to complement systemic therapy for metastatic disease by treating the liver where systemic therapies really don't have much of an effect, if any.

And there was some misunderstanding that we were trying to replace systemic therapies with regional therapy, which has never been our intention. And once that was cleared up that, of course, cancer is a -- metastatic cancer is a systemic disease and of course you need to treat it systemically, but the problem is when the disease gets into the liver, the patient typically dies of liver failure, and systemic therapies aren't very effective.

So once we got the idea across that this is a new tool to complement systemic therapies, not replace them in any way, then they got it right away. So that's really the only negative feedback I've heard over my tenure.

And, of course, as the ASCO data is disseminating, we are much more free and open to discuss and educate. So hopefully, we can clear up any misconceptions and clarify things.

Jim, the only -- this is Dave. The only other thing I would add to that, and I certainly haven't gotten anything from a medical standpoint, I think some physicians have said just ask the reimbursement question. You know, making sure they get paid and utilization so it's more of a marketing pushback not a clinical pushback.

(Operator Instructions). [Curtis Houck] with [Discovery] Capital.

Thanks for taking my question. First, would you be so kind to discuss the independent core lab results for the overall response rate as well as the overall progression free survival and the other secondary endpoints in the clinical trial?

Sure. The [core lab] data was what was released in April, and that is light data that is based on imaging studies that were dated independently by core lab as opposed to the investigators' team, investigators radiologists interpretation, if you will.

If you remember, the PHP hepatic progression-free survival was 214 days versus seven days for the BAC, which was again with a P value of 0.001 and a hazard ratio of 0.46 which is extremely good. Now that is what we -- the FDA cares for and that is what we presented them, obviously, along with the investigator data that we released at ASCO. And that had to be done that way because the ASCO abstract went in a lot sooner and it is not unusual -- not an unusual practice, as a matter of fact.

Having said that, the -- when you talk about the secondary endpoints and overall progression-free survival and so forth, the conclusions you draw are not at all changed by this one core lab analysis. Does that answer your question or --?

So they -- just so I understand this. The secondary endpoints, the overall response rate, and the overall progression-free survival and the other secondary endpoints are all the same, as assessed by the independent core lab as they were by the investigators?

Pretty much.

Yes. Yes, the numbers changed slightly but not materially.

And the statistical validity does not change at all, actually.

Okay. Thanks. And then just to follow up, the -- in Dr. Pingpank's presentation, he disclosed the toxicities from 40 of the patients in the the PHP arm, but didn't disclose the toxicities in the patients who crossed over from the BAC arm. Were those -- were the toxicities similar to the patients in the PHP arm, including the number of deaths and the grade 3, 4, and 5 toxicities? Or can you talk quantitatively or qualitatively about those?

Yes. So if you look at patients who are exposed to melphalan, that would also include patients who crossed over. The results are not any different at all.

And the reason Dr. Pingpank presented the way he did was in (multiple speakers).

Exactly. Yes. Just like he presented the overall survival. It was all an intent to treat analysis, which means you attribute whatever results you are reporting to where the patient in -- to the group the patient began in.

Okay. And so, there were how many total deaths in the study attributed to study drug?

There were a total of five. But three of them were attributed to the drug. And there were a total number of 67 patients who were exposed to PHP.

Okay. Great. Thank you very much.

And at this time, I'm not showing any further questions. Management, please continue.

Before concluding today's call, we would like to respond to shareholder questions submitted in advance that have not already been addressed. And our -- thank you, by the way, for all of your questions. And we are looking forward to answering those.

The first question that we're going to answer is, what is the status of the expanded access program? And is this program now accepting patients? And as background, we received FDA approval to open an expanded access protocol before we concluded the Phase III protocol which would have allowed for patients to be treated prior to -- continuing to be treated prior to FDA approval.

The status of the trial is that we have decided not to open that trial. And this was a very difficult decision for us to make in that we certainly wanted to provide patients access to the PHP system, prior to FDA approval.

But the Phase III results were so good and our likelihood of -- our belief and likelihood of getting FDA approval so high, that we felt that the best way to provide access to the most number of patients would be to get FDA approval in the most expeditious way. And we wanted to focus all of our resources on getting FDA approval instead of dividing them between getting FDA approval and conducting the access trial in parallel with that.

So it's one of those things where we would've liked to have done it, but it really would not have added any incre -- we didn't feel that have increased our likelihood of getting FDA approval because we already had more than enough in our -- from the Phase III trial data since the data was so robust.

Next question is, what is the outlook on financing and partnerships? I will hand that over to Dave.

All right. I will take the financing question first. As many of you know from listening to us since last fall, since we did the raise then, we've said we will require additional capital prior to becoming cash flow positive.

So with that said, though, we don't comment on timing and where it might come from. Clearly, we have many options with respect to the capital market and we continue to talk with potential strategic partners.

As Eamonn mentioned earlier, the timing on that is uncertain. And so all I can tell you is, yes, we will require additional capital before becoming cash flow positive. But I don't know when or from what source it comes from.

Next question is, is the Company still reluctant to self-promote success stories such as Linda Campbell's because the Company is still in the pre-approval stage?

And the answer to that is patient testimonials are readily available to us in that there are many patients who have benefited from the PHP system and are doing very, very well. The -- but during the approval phase, it is very, very unseemly for a company to utilize those stories to bolster itself.

So we will have to leave that to patient advocacy groups and the patients themselves to put the word out, which they do. And certainly, we are all encouraged by those stories, but you know we need to be very quiet as a company with regard to the benefits of the system outside of educational activities associated with trial data and the like. So we can't promote, but we can educate during the quiet period. And we need to stick to our guns there.

Next question, what is the status of our ongoing relationship with Chi-Fu Trading Company Ltd.? Specifically, are there any trials being developed and if there are, what are the timetables for the start of these trials and what would the trial protocol look like?

The status of our relationship with Chi-Fu is very strong. We are moving along with them. Part of our relationship with them is to partner with them to conduct a clinical trial in Taiwan on primary liver cancer, hepatic cellular carcinoma. And we would expect that that trial would be initiated some time in 2011. We are working on trial protocols now and, Kris, maybe you could share something on that?

Sure. We're -- we've decided that we want to do a Phase I and a Phase II trial there as well, because the population is different from the Western population in terms of size and so forth. Tolerability of the drug, perhaps. So we are preparing those protocols at this moment.

Great. Next question is probably best answered by Kris. After approval for metastatic melanoma in the liver, what will be your top priority for fighting other cancers?

Sure. To follow through, so when we get the melanoma approval or not waiting that long actually, we are going to pursue closely after with the ACC trials, as we said, in Asia. But we will also be doing neuroendocrine tumors and see -- and establishing some utility there.

And eventually we would like to, perhaps middle of next year or so, look at the colorectal [meds] to the liver.

Next question. What type of information was held back at ASCO in anticipation of possible journal publication? Should we expect to see updated results or a new analysis in different cohorts? Kris, you want to --?

Yes, the kinds of results that were really not held back but rather we reserve for our publication, the secondary endpoints are full, a full set of five secondary endpoints, and some subgroup analyses that are allowed within the statistical analysis plan of study.

And next question, are there any efficacy analysis that were pre-specified in the statistical analysis plan that were not presented by Dr. Pingpank at ASCO?

I guess here the answer is yes, and we will be including it in the publication we see coming forward.

And what would they be?

The subgroup analyses would look at PHP versus BAC in terms of progression-free survival. Obviously, duration of response (inaudible) toxicities and/or -- and so on.

Great. Well, we would like to thank you all and participants for their feedback. Thank you all for joining us today and your interest in Delcath and we look forward to keeping you abreast of our developments as they occur. Have a great day.

Thank you, ladies and gentlemen. That does conclude our conference call for today. If you would like to listen to the replay of today's conference please dial 303-590-3030 or 1-800-406-7325, using the access code 433-8101. Thank you for your participation. You may now disconnect.