Javelin Pharmaceuticals, Inc. Q1 2008 Earnings Call Transcript

Javelin Pharmaceuticals Inc. (JAV)

Q1 2008 Earnings Call

May 14, 2008 8:30 am ET

Executives

David Bernstein - General Counsel and Chief Intellectual Property Counsel

Stephen Tulipano - CFO

Martin Driscoll - CEO

Daniel Carr - Chief Medical Officer

Analysts

Adam Greene - JPMorgan

Ram Selvaraju - Rodman & Renshaw

Juan Sanchez - Ladenburg

Adam Cutler - Canaccord Adams

Gary Nachman - Leerink Swann

Presentation

Operator

Good day, and welcome to the Javelin Pharmaceuticals' First Quarter 2008 Conference Call. Today's call is being recorded. At this time, I would like to turn the conference over to Mr. David Bernstein. Please go ahead, sir.

David Bernstein

Thank you, Connie and good morning everyone. I have with us this morning, Mr. Martin Driscoll, CEO of Javelin Pharmaceuticals; Dr. Daniel Carr, our Vice Chair and Chief Medical Officer; and Stephen Tulipano, our Chief Financial Officer.

Before we begin, I will review Javelin's Safe Harbor statements. Certain statements made in the course of this presentation may be forward-looking and involve a number of risks and uncertainties. These forward-looking statements include statements about the following; our product development efforts, anticipated operating losses and capital, anticipated regulatory filing dates and clinical trial initiation dates, our estimates regarding our capital requirements and our needs for additional financing, our estimates for future revenues and profitability, our selection and licensing of product candidates, our ability to attract partners with acceptable development, regulatory and commercialization expertise.

The benefits to be derived from corporate collaborations, license agreements, and other collaborative efforts, including those relating to the development and commercialization of our product candidates, and sources of revenues and anticipated revenues, including contributions from corporate collaborations, license agreements, and other collaborative efforts for the development and commercialization of our product candidates, and the continued viability and duration of those agreements and efforts.

The matters discussed in our forward-looking statements are subject to known and unknown risks, uncertainties and other factors, which may cause our actual results, performance or achievements, or industry results to be materially different from the results, performance or achievements expressed or implied by our forward-looking statements.

Now, I'd like to thank you all for joining us today. Steve Tulipano, our CFO will comment on Javelin's financial results, then Marty Driscoll, Javelin's CEO will take a few moments on the quarter before we open up the phones for questions from analysts and institutional investors.

I would like to now introduce Stephen Tulipano, CFO who will provide Javelin's financial results. Steve?

Stephen Tulipano

Thanks, David. I would like take a few moments to review the results of the first quarter. At the end of the quarter, we had approximately 27.2 million in cash and marketable securities. Also we recently had an offering, which has provided an additional 25.7 million in net proceeds. Accounts payable and accrued expenses were approximately 7.8 million. For the quarter, our loss was 9.8 million or $0.20 per share with an average – weighted average, excuse me, shares of 48.8 million. Product revenues were 66,000 in the quarter and in line with our internal expectations for the first quarter of our launch in the UK much of that revenue by the way being generated by private hospital.

The sales and marketing team has focused their efforts on obtaining formulary reviews for the Top Tier NHS hospitals. Many of those formulary reviews resulted in formulary approvals late Q1 and into Q2. Cost of products sold were $50,000, these were higher costs in this period, which were primarily due to launch-related costs. As we move forward over the next several quarters we expect our margins to improve substantially. Javelin had total operating expenses of approximately 10.2 million for the quarter, which included 5.7 million related research and development and as you know includes manufacturing costs not capitalized with inventory and this was compared to 3.3 million for the same quarter of 2007.

All of these increases were driven largely as a result of increased clinical trial costs including clinical site fees, lab fees, data management costs, manufacturing and process development costs and increased head count. We also had 4.5 million in SG&A expenses for the quarter. Our SG&A increased by about 1.7 million over the same period in the prior year. The increases in SG&A were primarily due to increased costs associated with commercial scale-up activities. This included fielding a sales force, market research and other marketing costs related for the launch of Dyloject in the UK. And also included in non-operating expenses were about 844,000 related stock-based compensation expenses for the quarter. And we had 357,000 interest income for the quarter and that pretty much wraps up the quarter.

I would now like to introduce my colleague Marty Driscoll, Javelin's CEO, who will comment on our operational achievements today before opening the phone lines up for questions. Marty?

Martin Driscoll

Thank you, Steve. Good morning everyone and thank you for joining us this morning on our first quarter earnings call. As I said during our -- my first conference call with you just eight weeks ago in March as I assumed the role of CEO of Javelin, Javelin has entered a new and exciting phase and has become a commercial enterprise and with this must come a culture of change at Javelin. I think my colleagues here at the company would acknowledge that there have been significant changes in how we operate our daily business since I have taken the helm. And I can assure you more positive changes are forthcoming.

Javelin has become as you know, a leader in the development of prescription products for the treatment of pain. With three pain products in late-stage development and in the case of one of those products with a major market approval in a European market, we are well-positioned now to move from our pre-partnership phase into our global partnership stage and that is my focus. As you know, we just completed a financing. The current and new investors in this company are investing on the basis that we are going to successfully execute on this transition that I just mentioned. I will emphasize again, this company has three late-stage products, one in its early days of generating revenues. These are all attractive for many reasons for global partnership opportunities, which I believe these facts aren't reflected in our current market evaluation. Even if one were to discount my expectations for this portfolio and contrast that with our current market capitalization, one could see why investors weren't attracted to our recent offering, which I might add was oversubscribed. I would like to take a few minutes to show you the evidence of our focus on execution just in these weeks since our last conference call.

First, I have redefined the commercialization strategies for this company. Global partnerships for our products are available. The competitive interest in these partnership activities has intensified over the last several weeks. This new strategy will serve to reduce our commercialization risk for this company and should reduce our need for future capital, for commercialization purposes. Two, under the capable leadership of Dan Carr, we are increasing our resources in clinical development, so we can deliver clinical results and regulatory filings in a more efficient and timely manner. Third, Dyloject, the second of our two pivotal Phase 3 trials for this product will complete later this year. We remain on track to submit an NDA for the product in 2009. Importantly, it is my goal that this company -- that we will always strive to file approvable high quality NDAs.

As such we will err on the side of having more safety information than less. And as mentioned in the prospective --prospective supplement for our recent financing and the 10-Q, we are going to generate additional safety information for the Dyloject NDA by conducting a simple open label observation study. Timing of the filing for the NDA could be impacted, but I will lead this organization in a manner to ensure that we expedite this submission to the best degree we can. To benefit our timing, we have an opportunity to leverage the Dyloject market its status in the UK for this simple open label observational study. I want to emphasize, we have not observed any safety signal concern either from our clinical trials to-date or in the early use of Dyloject in the UK.

In addition, the FDA has not informed us of any specific Dyloject safety concerns. But in light of the evolving regulatory climate, with an emphasis on safety, I believe it is prudent for this company to be pro-active and augment the safety database for Dyloject. So, that we have the best possible reasons to file an approvable high quality NDA. Number four, PMI-150 intranasal ketamine, I am pleased to announce that we are ahead of our previous schedule and we will initiate our pivotal efficacy study this month.

Number five, Rylomine, since assuming the role of CEO I have examined this program and determined that I want the organization to focus its resources and its attention on filing high quality approval NDAs for Dyloject and PMI-150 in 2009. As such I am weighing the benefits to our shareholders of taking advantage of the significant unsolicited interest we have received in partnering this Rylomine asset versus continuing with the final stages of the products development ourselves. Six, partnership activities, as I told you in March one of my greatest near-term priorities will be executing robust partnerships for this company. Competitive interest in our portfolio continues to intensify. One of my first actions was the higher and experienced Head of Business Development. So, he could assist me in working closely with me in completing this priority in the near-term.

Seven, financing as part of our partnering strategy my fellow board members and I felt it was prudent to strengthen Javelin's balance sheet as our partnership discussions have intensified. Since I have assumed this role I have been impressed by the significant reverse inquiry from our existing shareholders and external funds that support this new strategy that I have articulated for the company, and see the upside potential if we are successful in executing. We believe this financing will take us through a transformational partnership for this company.

We are very pleased to have attracted several new well-known domestic and international specialty healthcare funds along with in additional investment from our long-term shareholders. I might also add that myself, Dan Carr and a fellow Director invested substantially in the aggregate in this financing. Let me now provide an update on the launch of Dyloject in the UK. It is still the early days and we are in the stage focused on formulary inclusions and less on revenue generation. We are encouraged by the early physician feedback on the use of this product. I like what we are seeing thus far and I remain comfortable with the analyst long-term expectations for the product in the UK.

Let me take a moment to describe the plan that we are executing for Dyloject in the UK. The first stage in marketing the product in UK was naturally to get approval. We achieved that in the late fall of last year of course as you all know. The second stage was the focus on gaining an optimal price. We achieved that in the latter weeks of the year. We are now in our third stage, which is making effective formulary presentations at the major UK institutions and generating a high percentage of formulary approvals. Our fourth stage will be to accelerate sales by pulling through the product utilization based on these formulary approvals that we will gain.

We are currently in our third stage of formulary exclusions. As Steve indicated, the revenues in the first quarter were in line with our expectations because our focus has been on formulary presentations and acceptances. Our formulary inclusion efforts are focused on the largest and the most influential hospitals in the UK what we call the Tier 1 institutions. We have already gained formulary acceptance at 16 Tier 1 institutions and 6 Tier 2 NHS institutions, for a total of 22 already. 90% of the institutions that have reviewed Dyloject for formulary inclusion thus far have placed the product on formulary. This success rate percentage exceeds our early expectations.

In addition, I might add that 20 private institutions have already put Dyloject on formulary. The number of formulary presentations and reviews will accelerate in the coming weeks and through the balance of the year. I hope you can see that in eight short weeks we are changing the way Javelin is doing business. And we are focused on these events that will lead to a real transformation for the company.

Thank you. I would now like to turn it over to questions from the audience.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). And we will take our first question from Adam Greene from JPMorgan.

Adam Greene - JPMorgan

Thanks. Good morning everyone.

Martin Driscoll

Good morning, Adam.

Adam Greene - JPMorgan

Marty can you talk about your decision to do an open label safety study for Dyloject. When do you think that it will start, how long should it last and by most importantly how much do you think about – the delay the filings for Dyloject? I think previously you had said second quarter '09 filings or is it six months I think its more late '09 rather than early '09? Then I may follow up.

Martin Driscoll

Sure. Adam – I am going to let Dan answer that if I may.

Adam Greene - JPMorgan

Sure.

Martin Driscoll

Thank you.

Daniel Carr

Yes. Thanks Adam for the question. Well let me reiterate what Marty said that we have seen no safety signal either from our clinical trials or our pharmacovigilance in the UK nor has the FDA informed us of any specific Dyloject safety concerns. But given the recent trend of the FDA to emphasize developmental processes that focused on safety, we are taking a belt and suspenders pro-active approach to anticipate regulatory directions by augmenting the patient numbers in our integrated summary of safety that confirms the recognized safety of diclofenac. Diclofenac as you know is the active pharmaceutical ingredient in the most recent to -- hence it's approved. So, we are speaking about a simple, efficient, observational, non-placebo controlled open label study that can leverage our having an approved drug on the UK market. So I would say that we are still on track to complete the NDA filing in late -- in 2009.

Adam Greene - JPMorgan

Thanks and follow-up on ketamine. Can you just remind us of the trial design for that and how many patients how long? And how confident are you with that product that the FDA will accept just one pivotal study? Then, also if you could update us on the status of the breakthrough pain trials for that product?

Martin Driscoll

Great, let Dan take that again Adam.

Daniel Carr

Well, first of all again as we have emphasized we have a fine relationship with the FDA and we enjoy open communications and I reiterate that it's our understanding we are doing what is necessary by having that trial complete to file a high quality NDA. While no drug company can produce – can predict every regulatory development we can certainly do our best to anticipate it. Based upon our previous discussions with FDA we are looking at a very simple trial in elective same-day orthopedic surgery, where we would compare PMI-150, our intranasal ketamine product with placebo over several doses for several hours in order to fulfill the check box for a multi-dose efficacy trial. We anticipate there will be about a 150 patients in that trial.

Adam Greene - JPMorgan

Okay, thanks.

Martin Driscoll

Yes.

Daniel Carr

Thanks Adam.

Operator

And we will take our next question from Ram Selvaraju from Rodman & Renshaw.

Ram Selvaraju - Rodman & Renshaw

Hi. Thanks very much for taking my question.

Martin Driscoll

[inaudible] Ram.

Ram Selvaraju - Rodman & Renshaw

With respect to the decision on whether or not to continue with the pivotal development of Rylomine versus partnering it, could you provide a little bit more color on what the timing of that decision might be?

Martin Driscoll

I do not know Ram that I want to point to a specific date. I can tell you that I want -- as I indicated in my opening remarks, I want the organization focused on Dyloject and intranasal ketamine, because of the potential, the greater potential that exists there. In addition to that, it's important to note we have had unsolicited interest in Rylomine, being that it's a late-stage product and that we believe has differentiating features. As a result I need to weigh all those factors with ensuring that this company is focused on what we can do best. So, we will be giving you more information as we proceed, but I thought it was important to examine the program and take advantage of the interest that's been expressed in the asset and weighing that versus deploying this company's attention over to that, while we are also focused on, as Dan indicated and I indicated earlier, filing good NDAs for Dyloject and intranasal ketamine.

Ram Selvaraju - Rodman & Renshaw

Okay and with respect to the future of the European launch of Dyloject. John could you talk a little bit more about what the process is likely to be like in subsequent European territories aside from the UK and whether or not this would follow a sort of analogous procedure of placing high priority initially on formulary inclusion?

John Taylor

Yes I – each market as you can appreciate is different. Each territory is different, they have their different dynamics -- different competitive dynamics; different reimbursement dynamics and you have to evaluate each market on the basis of those merits. So, in the case of the UK you have to first gain your price from the government, and it's not until you have that price that you can even make the phone calls to set up the formulary presentation that's an important point. Though, these formulary presentations couldn't even be solicited to occur until after we had the price, which was late in the year. In the case of Germany, the reimbursement environment in Germany, which is the second market that we are pursuing, the reimbursement environment is more similar to the United States, if you were where there is a DRG-like process. So, we have – we are evaluating each territory on the basis of market potential for Dyloject based on the commercialization requirements that are necessary. And then we will give more guidance as we move forward on the markets we'll pursue and in what order based on the – based on that review.

Ram Selvaraju - Rodman & Renshaw

Okay. And could you just say when you expect to be more or less wrapped up with the formulary inclusion application process in the UK?

John Taylor

Yes, well they are always going to be going on. We will always be pursuing additional institutions and moving forward. We are focused on the Tier 1 institutions in United Kingdom. We target about 200 of these, which represent the bulk of the potential for Dyloject's use. The number of formulary presentations are accelerating here in the second quarter and particularly into the third quarter because you have to schedule the meetings and do your work. So, I would – I would guesstimate that based on the review I have done with my team that the bulk of the formulary presentations for the Tier 1 institutions will have taken place by the end of 2008.

Ram Selvaraju - Rodman & Renshaw

Okay. And just one quick question for Steve if I could. Steve could you give me the precise number of shares outstanding at the end of the reported quarter please?

Stephen Tulipano

We have 49 million shares outstanding at the end of the quarter.

Ram Selvaraju - Rodman & Renshaw

Okay. Thank you.

Stephen Tulipano

Take into consideration that we just had an offering.

Martin Driscoll

Right.

Ram Selvaraju - Rodman & Renshaw

Thank you.

Martin Driscoll

Thank you, Ram.

Operator

And we will take our next question from Juan Sanchez from Ladenburg.

Juan Sanchez - Ladenburg

Good morning guys.

Martin Driscoll

Good morning, Juan.

Juan Sanchez - Ladenburg

Could you give us an idea of the cost of running your operations in the United Kingdom on the timing of a possible approval in Germany, and the cost of running your operations in Germany, you decide to commercialize in Germany as well?

Martin Driscoll

Juan we do not break out and reveal publicly our individual costs for individual markets. I will tell you that we still anticipate an approval in Germany for Dyloject in the latter half of this year.

Juan Sanchez - Ladenburg

Thank you.

Martin Driscoll

You are welcome.

Operator

(Operator Instructions). And we will take our next question from Adam Cutler from Canaccord Adams.

Adam Cutler - Canaccord Adams

Hi, thanks for taking my question. I am wondering on this additional open label safety studies for Dyloject whether this was a result of any conversations you had with the FDA even if it wasn't something they were explicitly requiring?

Daniel Carr

Yeah, as I mentioned we try to remain abreast of what are the regulatory developments and trends and also we don't go into specifics of discussions with regulatory authorities. And I go back to the primary important point that there are no safety signals either from our clinical trials or pharmacovigilance, and our approach to this study is one where we are seeking to augment the numbers that will ultimately be in the integrated summary of safety for high quality NDA in 2009.

Martin Driscoll

Adam, I came into the role as well and I wanted to ensure that this company does everything it can to seek to file high quality approval NDAs and I felt it was prudent that this company be proactive and strengthen the ISS when we file this NDA with the FDA. And I think it's a prudent proactive thing to do and as Dan indicated we have the benefit of doing a open label operation study and the benefit of utilizing the fact that we have a marketed product in the UK.

Adam Cutler - Canaccord Adams

Okay, is there anything, as you noted so far the safety profile of the products is very clean. Is there anything in particular that you are -- you hope to accomplish with the safety study in terms of ruling things out? Is it -- part of it sort of bias that end-sets cause bleeding even though you have studies to show that that may not be the case with your product?

Daniel Carr

There is no particular safety concern and as you refer we already presented some very exciting and excellent data showing that our product -- that the higher of the two anticipated US. doses does not bump the platelet aggregation function outside of the normal range. So, it is simply a case of having a more robust safety experience in the NDA for the product.

Adam Cutler - Canaccord Adams

Okay, fair enough, if I could just ask you a couple of other questions on the Dyloject experience in Europe?

Martin Driscoll

Sure.

Adam Cutler - Canaccord Adams

You mentioned that 90% of the formulary committees that have reviewed the product have included it on their formularies.

Martin Driscoll

That's correct.

Adam Cutler - Canaccord Adams

I am wondering if you could just share us with a little bit -- I mean that's obviously a very successful rate, but that being said I'm just wondering if you have gotten any feedback on the 10% that haven't? Is it materially a timing issue or is there --?

Martin Driscoll

One was that – to be specific there were three specific rejections, the first occurred literally in the second week of January before our people had gone to the institution and before our people could present the formulaic economic benefits of this product. I think you are familiar, Adam, with that particular assessment, which has benefited our early formulary success rate in the UK Literally, an individual at the institution filed for the formulary review without our involvement and the committee rejected it. We re-filed that this week, because we have the appropriate pharmacoeconomic data. In the other two instances, there was a discussion about -- in one case a competitive product parecoxib was preferred on the formulary. Interestingly what we are seeing in our early days is that Dyloject is actually replacing parecoxib use in a number of institutions. So, we are very encouraged by the success rate thus far and I feel pretty comfortable in the one institution, where the one rejection occurred that we would be able to get it accepted there.

Adam Greene - JPMorgan

Okay. And then you ran through quickly kind of the number of formulary approvals --

Martin Driscoll

Yeah, right.

Adam Greene - JPMorgan

Could you give us just some context for that in terms of what that represents in terms of the market --

Martin Driscoll

Well, first Adam our strategy has been to focus on the largest, if you will, most influential institutions, many of them in the general London vicinity for example. The more influential, because they can affect outlying institutions, that is a similar effect that you will see in the United States. We focus there, they are bigger institutions and as I indicated 16 of those institutions have already approved it. Interestingly, the other six, which are Tier 2 moved quicker than we anticipated frankly. But all of our efforts are focused on these Tier 1 institutions. I might mention that a lot of the use -- there is a small, but growing private insurance marketplace in the UK and a number of the anesthesiologists in the UK if you will moonlight in those institutions. And interestingly they are gaining a -- there's a rapid uptake in the private institutions and they are getting their use if you will their trial in the private institutions and that's benefiting their support for the product in the NHS institutions, where there is a more deliberative and extensive formulary review process.

Adam Cutler - Canaccord Adams

Okay, so I guess just for to maybe ask you in a different way. I mean, can you give us a sense maybe of the institutions that have put Dyloject on the formulary? What they represent in terms of percent of the IV analgesic use in the UK. You know, what I mean I'm just trying to see how far you have penetrated into the potential market so to speak formulary wise?

Martin Driscoll

Adam, I don't know that answer for you. I -- except to tell you that you need to look at the formulary effort in its totality and look at it when we can particularly -- I would indicate in the latter quarters of this year as the number of presentations accelerate. I don't know that – I don't – I think your question is can I forecast based on just these first weeks of formulary presentations and I don't think I can. Instead, what I would mention is that an important element in the UK is you can't even schedule a formulary presentation until you have had your price. So, an individual with our company can't even schedule the meeting until that's occurred back in the – roughly the early part of December. And the number of formulary presentations will really accelerate and there for examples are a number scheduled for this month that are already been ongoing and accelerate. So, I think we would be able to give a better sense of that in the latter part of this year.

Adam Cutler - Canaccord Adams

Okay. I think maybe, I'm not being clear, I'm actually not asking for a forecast, but for instance if there was one hospital that represented 10% of the IV analgesic use in a country and you have that one hospital, then you could say that you had formulary approval covering 10% of the market. Do you understand what I am saying, so you had a certain number of formulary approvals I'm just wondering what those institutions represent as a percentage of IV analgesic use in the country. Just to get a sense of how far you are given that you are focusing on the most important institutions first.

Martin Driscoll

I don't know that answer.

Adam Cutler - Canaccord Adams

Okay. And then maybe one last question, and then I will hop back in the queue. It is just -- to what extent inventory stocking, is it play in the UK and how that might affect sales in the next several quarters.

Martin Driscoll

We are producing sufficient products, producing at our primary supplier --

Adam Cutler - Canaccord Adams

And you ship directly to the institutions?

Unidentified Company Representative

We have product out there and the product is being delivered. We are seeing reorders in those institutions that are – put the product on the formulary and ordering. Might mention also -- I think we have publicly mentioned we have a secondary supplier Baxter, who is the secondary supplier of Dyloject and one of the premier sterile manufacturers in the world. So our supply is good and reorders are occurring in those institutions where we have done formulary.

Adam Cutler - Canaccord Adams

Okay and you ship directly to those institutions?

Stephen Tulipano

Yeah, Adam this is Steve. We follow a sell through model so we ship directly to the institutions and revenues are recognized at that point.

Adam Cutler - Canaccord Adams

Got it. Thanks a lot.

Martin Driscoll

Thank you Adam.

Operator

And we will go next to Gary Nachman from Leerink Swann.

Gary Nachman - Leerink Swann

Hi good morning. First also on the UK in terms of process, Marty how long does it take I guess from the time a formulary approves the product for it to be used by physicians? I guess getting from the third stage to the fourth stage as you described it?

Martin Driscoll

The – the direct answer, Gary, is it depends on the institutions. It's no different than the United States. Institutions – the first thing is they have to approve the product for use by physicians in the center, in the institution and every institution has different processes and different methodology, so a direct answer to that it will depend on the institution.

Gary Nachman - Leerink Swann

Okay and is it something that takes a lot of marketing and promotions from your sales rep? Or is it something that just happens, once it's approved on the formulary typically?

Martin Driscoll

Gary, one of the strengths of our portfolio is that, it is a true specialty marketplace portfolio. The hospital driven portfolio, in the case of Dyloject that's certainly the case. And in the UK, in particular the anesthesiologists drive the business. It's very simple and it is not a broad swath of anesthesiologists, so you have the capability of going very quickly to those individuals, those physicians that will drive utilization.

Gary Nachman - Leerink Swann

Okay, and in terms of the partnership discussions, I guess you are still focused on getting a global partnership. Could Dyloject in Europe still be a part of that? Is that still on the table?

Martin Driscoll

It's on the table, yes.

Gary Nachman - Leerink Swann

Okay. And I guess for either you or Steve, now that you guys raised more money, should we assume that cash burn will continue at around 10 million per quarter or will that come down I guess without Rylomine moving forward?

Martin Driscoll

No, you can anticipate a similar burn rate. And it is important – of course that could be affected by a number of dynamics not the least of which is whether we execute a partnership. It's going to have significant favorable impact on that.

Gary Nachman - Leerink Swann

Okay and is the additional open label study for Dyloject a significant expense or is it nominal?

Martin Driscoll

No, we don't believe so at this point.

Gary Nachman - Leerink Swann

Okay. And then for Dan I guess on ketamine, for that product will you take a more conservative approach as well in terms of a safety package or do you think this new study that you are running will be enough or are you going to have to supplement that sort of the same approach that you are doing with Dyloject?

Daniel Carr

Well, I emphasize – it's our understanding that we are taking an approach that will do what's necessary to file a high quality NDA and no drug company can fully predict every regulatory development, but we have done and are doing our best to anticipate these.

Martin Driscoll

You know, Gary as Dan indicated, we are in constant dialog with the agency, I think the company has a very strong relationship with the agency and we are excited that we are now able to embark on the pivotal efficacy trial as I indicated earlier, a bit ahead of schedule. We have gotten feedback on that trial design obviously and we are ready to go and we will be initiating this month. That said we believe what we are doing is necessary as Dan indicated to file the NDA in 2009 in a high quality basis. We work – we do everything we can, to anticipate what the agency will require, we can't completely predict everything that it will require.

Gary Nachman - Leerink Swann

Okay. So, you should be able to file PMI-150 in 2009 as well.

Martin Driscoll

That's a bit of understanding today. Yes.

Gary Nachman - Leerink Swann

Okay. And I guess a date on that would it be around a year from now. Is that a fair assumption?

Martin Driscoll

Roughly, yeah.

Gary Nachman - Leerink Swann

Okay. Right thanks.

Martin Driscoll

Thank you Gary.

Operator

And that concludes the question-and-answer session today. At this time I would like to turn the conference back over to your presenters for any additional or closing remarks.

Martin Driscoll

Well I want to reiterate my thanks to everybody who is listening to this call for your interest and your support of Javelin. We are today -- is that my fellow colleagues and I are embracing change and we are taking rapid actions to unlock sustainable shareholder value. As Javelin's new CEO, I would like to acknowledge the contributions of everybody at all levels of Javelin, as well as our shareholders and partners in the investment community. Javelin has entered an exciting new phase in its evolution and I look forward to providing you with further updates as we continue to execute our refined commercialization strategy, to create meaningful global partnerships, and meet all clinical and regulatory objectives. Again I thank you for joining us today and I look forward to working with you in the future.

Operator

And that does conclude today's conference. We thank you for your participation you may now disconnect.

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