Tram Bui - ‎Vice President, Investor Relations, The Ruth Group David Gonyer - President and Chief Executive Officer Matthew D’Onofrio - Executive Vice President, Chief Business Officer, Secretary and Treasurer Marilyn Carlson - Chief Medical Officer.

Ram Selvaraju - Rodman & Renshaw Yale Jen - Laidlaw Capital Markets Vernon Bernardino - FBR & Co..

Good afternoon and welcome to Evoke Pharma's fourth quarter and year-end 2016 earnings conference call and audio webcast. With me today are Dave Gonyer, Chief Executive Officer; Matt D’Onofrio, Chief Business Officer; and Dr. Marilyn Carlson, Chief Medical Officer of Evoke Pharma.

Earlier today, Evoke issued a press release announcing financial results for the 3 and 12 months ended December 31, 2016. We encourage everyone to read today’s press release as well as Evoke’ annual report on Form 10-K, which is filed with the SEC.

The company’s annual report and press release are also available on Evoke’s website at www.evokepharma.com. In addition, this conference call is being webcast through the company’s website and will be archived there for future reference.

Please note that certain of the information discussed on the call today is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Evoke’s management will be making forward-looking statements.

Actual results could differ materially from those stated or implied by these forward-looking statements due to risk and uncertainties associated with the company’s business.

These forward-looking statements are qualified by the cautionary statements contained in Evoke’s press releases and SEC filings included in its annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 15, 2017.

Evoke undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would now like to turn the call over Dave Gonyer..

Thank you, Tram. And thank you all for joining us this afternoon for Evoke Pharma’s fourth-quarter, full year 2016 earnings conference call. We’ve had an eventful year, a very noble year-end and have entered 2017 on a very positive footing.

I’d like to discuss the tremendous progress we've made since our last earnings call, highlight our clear path forward with FDA as we move closer to an NDA filing for Gimoti. Following my remarks, Matt D’Onofrio will discuss the financial results for the fourth quarter and full year before we open the call for questions.

Let me just start off by saying that we remain convinced that Gimoti, novel nasal formulation of metoclopramide, if approved, will be the best available treatment option for patients with symptoms associated with acute and recurrent gastroparesis.

After two recent pre-NDA meetings with FDA, we're encouraged by the agency’s interest in providing outpatient alternative to the currently available oral tablet option, which unfortunately is not always effective in treating patients, especially when the patient presents with nausea and vomiting during a gastroparesis flare.

It is important to note here the key benefits of pursuing approval for Gimoti. Recall that gastroparesis is a disease that limits the delivery of food or oral medications into the small intestines. This made treatment of gastroparesis more difficult and unpredictable for any oral medication.

By delivering metoclopramide nasally, Gimoti bypasses the GI absorption issues for patients suffering from the disease. This is further exemplified by those patients who are unable to absorb medications due to nausea and vomiting, which is common with gastroparesis.

Given oral metoclopramide remains the only outpatient FDA approved drug to treat the disease, we remain dedicated in the development of an improved treatment with Gimoti to help treat these patients with gastroparesis.

After we announced the top line results for the Phase III trial with Gimoti last July, it was imperative that we carefully analyze the data, especially in light of the FDA’s draft guidance published in July 2015 regarding the clinical evaluation of drugs for the treatment of gastroparesis.

The FDA guidance recommended that gastroparesis trials should enroll patients with higher symptom severity in order to optimize the ability to demonstrate the treatment effect. Unfortunately, this guidance came after our Phase III trial was underway and patient enrollment nearly completed.

However, our analysis of the Phase III data, which we published in January, demonstrated statistical significance for Gimoti in patients with moderate to severe gastroparesis symptoms at the time they entered the study. Although, post hoc, we believe the results of this analysis were consistent with the FDA guidance.

Our Phase III trial, which was a US, multicenter, randomized, double-blind, placebo-controlled study, enrolled a total of 205 symptomatic diabetic gastroparesis patients, of whom 51% had moderate to severe symptoms at enrollment.

Within this population, the results showed a statistically significant improvement in symptom scores for those treated with Gimoti compared to those who received placebo. This was demonstrated at multiple time points in [indiscernible] protocol population with reported benefits seen as early as the first week of treatment.

Furthermore, there were also clinically and statistically significant improvements in nausea and upper abdominal pain, which can be two of the more severe and debilitating symptoms of gastroparesis.

These results are consistent with the benefits seen in our Phase IIb trial where Gimoti demonstrated statistically significant improvement in the individual symptoms of nausea and upper abdominal pain compared to placebo. As a reminder, in August 2016, we held our first pre-NDA meeting with the FDA to discuss non-clinical aspects of an NDA.

Following that positive meeting, we held a second pre-NDA meeting in December to discuss the clinical data which focused on the inclusion of additional data for 505(b)(2) NDA filing.

As a result of our discussion, FDA agreed that the demonstration of equivalent exposure to the currently listed drug, Reglan tablets, in a healthy volunteer pharmacokinetic trial could be used as a portion of our NDA submission for Gimoti.

FDA also agreed that an additional Phase III trial would not be required if the bioequivalence criteria were met in a comparative exposure PK trial. We believe that these discussions with the agency have helped lay out a clear path forward to an NDA submission for Gimoti.

And last month, we received a letter from FDA exempting Gimoti from a Human Factors Validation. A Human Factors Validation study is a pre-NDA submission requirement for drug device combinations as outlined in guidance issued by the FDA in February 2016.

In our August pre-NDA meeting with the FDA, we confirmed various regulatory, CMC, and non-clinical requirements for a potential NDA submission. This included the submission of a human factors assessment to the agency.

At the end of October, we delivered an assessment that analyzed the risk factors associated with Gimoti, taking into account its intended use environments, product use interface, and associated medical factors.

We are very pleased that the FDA agreed with our conclusion that the data we provided have adequately addressed the limited risk associated with Gimoti nasal spray and that a Human Factors Validation study is not necessary at this time.

This exemption helps free up time and resources for our team, so we can continue to focus on completing the PK trial and sections of the NDA. But more importantly, we believe this also helps to further de-risk our path to an NDA submission.

Now, let me move on to our current objectives for the year ahead and provide a general timeline that we believe will bring us to an NDA submission for Gimoti by late 2017 or early 2018.

All of us at Evoke and with the assistance from a team of skilled external experts have been moving quickly to implement the necessary steps to support the preparation and submission of an NDA. This includes preparing clinical trial material and, in parallel, also selecting the optimal site to perform the PK study.

As we've mentioned before, the study will be shorter in duration and less expensive compared to a Phase III study, owing to the fact that the study will enroll healthy volunteers, as well as being a fairly standard protocol for a comparative exposure trial, which typically requires only a few months to complete.

And we expect to complete the trial in the second half of 2017. We look forward to providing more detail on the PK trial in the near future as we finalize the various pieces of the process. In all, we believe these noted activities will bring us to an NDA submission by late 2017 or early 2018.

With that said, I’ll segue quickly to our cash and cash burn before I conclude and hand the call over to Matt to discuss the financials in greater detail. Evoke is in a much-improved financial position with a healthy cash balance. We reported that there were $9 million of the balance sheet at the end of the year.

With our recent capital raise of about $8 million, we believe this gives us a runway to February 2018. The level of interest as well as the quality of investors that participated in the capital raise in February has reinforced our excitement for what we can achieve this year and beyond.

You can reference our SEC filings for more information, but I wanted to highlight inside participation from lateral venture partners, who have been invested in Evoke since our Series A private financing in 2007. We continue to be active and meet with new investors and current shareholders to reaffirm our confidence in the potential for Gimoti.

And additionally, we look forward to maintaining our presence at upcoming medical meetings, such as Digestive Disease Week in May which we were present last year. These meetings will help us garner additional interest and attention to our unique position. In closing, we recognize the approval route Gimoti is undergoing is an alternative path.

Our NDA plan has been the subject of some of the most positive discussion in face to face meetings we’ve had with the FDA. We believe the constructive meeting and the ongoing two-way communications we’ve had is a very important sign of a shared goal to bring patients a new and improved treatment for gastroparesis.

And with that, I’ll turn it over to Matt to discuss the financial..

Thanks, Dave. From a financial position, we had a great start to 2017 with our successful public offering last month that brought in $8 million in gross proceeds, which puts us in a comfortable position to complete our outlined milestones and have a cash runway into early next year. First, let me start with the three-month results.

In the fourth quarter, we reported a net loss of $1.5 million or $0.12 per share based on weighted average shares outstanding of approximately 12.3 million shares as compared to a net loss of $2.6 million or $0.37 per share based on approximately 7.1 million weighted average shares outstanding for the fourth quarter of 2015.

R&D expenses for the fourth quarter were $1.5 million, down from $1.7 million in the fourth quarter 2015. General and administrative expenses in the fourth quarter of 2016 were $822,000 compared with $843,000 in the fourth quarter 2015.

Total operating expenses for the fourth quarter were approximately $2.3 million compared to total operating expenses of $2.6 million in the fourth quarter 2015. And now for the 12 month results ended December 31, 2016.

For the full year ended December 31, 2016, net loss was $10.7 million or about $1.15 per share based on approximately 9.3 million weighted average shares outstanding. This compares to a net loss of $12.1 million or $1.87 per share based on approximately 6.5 million weighted average shares outstanding during the year ended December 31, 2015.

Research and development expenses during the year of 2016 were 7 million compared with 8.2 million during the year of 2015. General and administrative expenses for the full year of 2016 totaled $3.6 million compared with $3.7 million in the same period a year ago.

Total operating expenses for the year ended December 31, 2016 were approximately $10.5 million compared to total operating expenses for the year of 2015 of $11.8 million.

Of note, included in the net loss for the fourth quarter of 2016 and year ended 2016 was a reduction of net loss due to the change in the fair value of the warrant liability of approximately $797,000 and $598,000 respectively.

The warrant liability is subject to re-measurement at each reporting period and we recognize any change in the fair value of the warrant liability in the statement of operation.

We anticipate that the value of the warrants could fluctuate from quarter to quarter and that such fluctuation could have a material impact on our financial statements from quarter to quarter and year to year.

Finally, to our balance sheet, we ended 2016 with cash and cash equivalents of $9 million and we raised approximately $8 million in gross proceeds from an offering we completed in February and March.

We believe that our strength and balance sheet will give us a runway into early 2018 and that the new and existing investors who took part in the offering reinforce our positive state of affairs at Evoke. That concludes our remarks and we’d now like to open the call to questions. I’ll give it to the operator. .

Thank you. [Operator Instructions] Our first question is from Ram Selvaraju of Rodman & Renshaw. Please go ahead..

Hi. Thanks very much for taking my questions and definitely congratulations on all the progress that was made at the end of last year and early this year – so far this year.

I just wanted to ask whether you could provide us with some more color on the process via which you expect to select the CRO for the performance of the PK study and what specific factors are going into that.

And also if you could give us more granularity on the status of the preparation of additional material, the manufacturing of that material that’s going to be necessary for you to complete the additional NDA enabling work prior to the submission of the filing. Thank you..

Thanks, Ram. Good question. I’ll turn the clinical piece over to Dr. Carlson, but I can make mention to the clinical trial material. We are currently working through that with the manufacturing group that we use now. Obviously, it takes a little while to get that up and running and then manufacturing. So, that’s the key piece that we’re doing now.

So, we’re working through that to get that done just as soon as possible. In terms of the site and different groups that we’re looking at, I’ll let Dr. Carlson respond to that..

Hi. Good question. We like to go back to sites that we’re familiar with and we also look for sites that have history with nasal spray studies. We think that’s critical for their success.

The other factor we look at is, obviously, their clean regulatory inspection history and also the capacity to deal with the number of subjects and to do it in an efficient manner, so that we can maintain our timeline..

Thank you very much..

Thanks, Ram..

Thank you. The next question is from Yale Jen of Laidlaw. Please go ahead..

Again, also add my congrats on the progress. Maybe a few questions here. The first one is that I know you guys may provide more colors in terms of the PK study in the future, but at this point was there any additional color you can share, whether that would be the patient sites or other aspects of it..

Not until we nail down all those pieces, Yale. Appreciate the question, for sure. But we will provide that information just as soon as we nail everything down. We don’t want to jump ahead of ourselves and put out something that may not be exactly what we want to perform..

Sure. Not a problem. And two quick questions.

The first one is any sort of rough guidance in terms of the run rate for the year – for 2017, maybe even thinking about the future, what’s the thought there?.

Sure. Yale, this is Matt. Thanks for the question. In the past, obviously, our burn rate had gone down quite a bit as we had completed the clinical activities in 2016. We do expect that to move up to a certain extent given the trial that Dave has described, along with some manufacturing and preparation for that.

Right alongside, we’ve also noted publicly that we are preparing to submit the NDA. And that one, in terms of engaging an organization and consultants to assist us with that will increase the burn to a certain extent. Otherwise, we can’t give any – very specific numbers of the overall time until we run to cash zero, so to speak, into early 2018.

That should give us some estimate around how we’re preparing for that. The thing to note, which is very important as we get much closer to commercialization, we will expect to start investing in some of those activities later in the year as we get closer to that submission and preparation for commercialization opportunities as well..

Well, thanks for the details. In fact, the second part answers part of my question – about to ask a question. So, you already answered it. And the last one is a housekeeping question, which is that, as I look at the third and fourth quarter of last year, the two items.

One is the interest expense, the other is financing costs related to warrant liability. Both of those did not appear in the fourth quarter.

Do those two items probably would possibly disappear on the 2017 as well?.

So, just to make sure I’m capturing you correctly, in terms of interest expense, since we terminated our debt situation and the debt vehicle last summer, we don't have any debt as it were. So, I think that may address your first question around interest expense.

And then second to that, in terms of warrant liability, so that will change quarter to quarter. And again, it’s a non-cash expense. So, it’s not a – it’s not something we’re actually spending money on. It’s just a financial recognition that can fluctuate somewhat substantially.

And I think we described that very quickly in terms of the numbers for both the fourth-quarter and for the year end..

Right. So, you’re talking changes – I’m talking about financing costs related the warrant liability.

Are we talking about the same aspect or are we talking of different ones?.

I get it. So, in terms of those specific costs, they were in the third quarter because that occurred in July/August. So, that’s why you didn’t see it in the fourth quarter..

Great. Thanks a lot. Again, congrats. And look forward to see more details as things move forward..

Thanks, Yale..

Thank you, Yale..

Thank you. The next question is from Vernon Bernardino of FBR. Please go ahead..

Hi, everyone. Thanks for taking my question. And congrats also from me for the accomplishments in 2016 and positioning yourself in 2017. I just had a question as far as the preparations are concerned, I remember about a year ago you had enlisted RPI.

Just wondering, are there any other preparations that RPI would be involved in and perhaps what they would be required to as far as the activities are for an NDA?.

This is Marilyn Carlson. Maybe you can clarify – hi. Maybe you could clarify the question for me, so that I make sure I answer it correctly..

Sure.

I’m just wondering, are they still involved? And what activities still need to – what activities are they still involved as far as preparing the NDA?.

Well, RPI has been involved with us. They help us with our submission. The details of how we’re going to prepare the NDA and exactly who we will have helping us, we haven’t finalized and released that information yet. So, that’s about all I can say for now. But we will require assistance from one or more vendors to accomplish the NDA..

Okay, perfect. I’m sorry that I missed this.

What activities will you have at DDW this year?.

Well, we will probably make some announcements as we hear back from DDW in the next month or so..

Okay. So, that means you have some data or….

Yes, we hope to. Yes..

Okay. Okay, that’s all I really have. Obviously, DDW is something that I’d like to [indiscernible] this year and so just wondering if you could provide us some detail before then. Thanks for taking my questions. Congrats again on the progress in 2016..

Great. Thanks, Vernon..

Thank you. The next question is from Ram Selvaraju of Rodman & Renshaw. Please go ahead..

Hi. Thanks for taking the follow-up. These are really related to the commercial situation and potentially the kind of patient population would be targetable with Gimoti.

I was wondering if you could give us a bit of a framework with respect to the type of gastroparesis patient that you would most likely expect to be treated with Gimoti, specifically with respect to the amount of time such a patient might have been suffering from diabetes and the nature of the symptomatology of the disease.

As well as maybe if you could clarify something you said at the beginning of the call regarding the use of Gimoti in acute and recurrent gastroparesis, what does that really mean? And also, if you could give us a sense of your thinking from a strategic standpoint regarding the timing with which you would expect to want to make a decision on whether or not to take the drug to market yourselves or to potentially commercialize it with a partner on board? And with those two scenarios, maybe give us a sense of, commercially speaking, what kind of sales and marketing you would expect to put behind the product..

Great. Thanks, Ram. I’ll let Marilyn comment on the first part and Matt comment to your second part of your question..

Okay. And if miss any, hopefully, you’ve got a list there. We have studied diabetic gastroparesis in our trials. And the label that we will be seeking under our 505(b)(2) NDA will be the Reglan indication, which is the treatment of symptoms associated with acute and recurrent diabetic gastroparesis.

So, that, I think, answers your question about what is acute and what is recurrent. So, we will be seeking that. The type of patients who receive metoclopramide can vary as long as they don't have any of the conditions that are listed in the package insert, which would be a contraindication to giving them a motility agent.

For example, they have some type of blockage in the GI tract. Other than that, if motility is where their problem resides, then physicians may decide that if it works in diabetic gastroparesis patients, it may work in some of their other gastroparesis patients. And we know that in clinical practice, it’s used in idiopathic as well.

But, again, our label will be more consistent with the Reglan label and that label does recommend the use in diabetic gastroparesis..

Okay.

And just as a follow-up to what you just said, if we think about this as being potentially applicable as a pro-motility, we’ve seen in the past cases where drugs were approved for, for example, chronic idiopathic constipation and saw significant extended use in constipation predominant irritable bowel syndrome, just as an example, mainly because prescribers don't tend to differentiate between the two.

Do you see any potentially analogous situations developing for Gimoti in the marketplace, given that it would be positioned and promoted using the Reglan label, but is effectively regarded as a pro-motility agent? And if so, what might be some additional types of patient who could conceivably be prescribed Gimoti in its capacity as a pro-motility agent?.

Well, one of the common scenarios that Reglan is currently used is everyone who goes for a colonoscopy and has to a drink a jug of liquid bile preparation is often receiving that jug with a 5 mg Reglan tablet taped to the lid. It’s very difficult to move that volume of liquid even through a normal GI tract comfortably without nausea and vomiting.

So, that type of scenario would also lend itself to administration of Gimoti. We know that it is used in a variety of situations for nausea and vomiting. Somebody goes into an emergency room, severe migraine or other causes of severe nausea and vomiting, they often get a dose of metoclopramide.

It’s also used in the postoperative setting where there is a great deal of nausea and vomiting associated with procedure. So, there are many ways in which it can be administered – intravenously, intramuscularly or orally.

And some or any of those may be a situation where a doctor would find that Gimoti would offer a better alternative for that particular patient..

Okay, that’s very helpful.

And I assume that in the nausea and vomiting case particularly, given the nature of that symptomatology, an intranasal formulation might potentially be considered quite preferable to an oral disintegrating tablet, correct?.

I think you probably heard Dave say early in his remarks that we think it’s the best treatment option for patients who have that type GI symptomatology because it totally avoids them having to drink the water, take the pill, or go into a medical setting where they can receive an injection..

Right. Thank you..

Welcome..

So, Ram, this is Matt. You made some questions regarding some strategy, concepts and potential commercialization, we have stated previously that we meet with a number of other GI organizations that have current sales and marketing organizations in the field today.

There is always a continuous review of different assets available and things that are coming to market. We meet with them frequently. They are aware of our progress. Should anything come to pass, we’ll have to wait and evaluate at that time. My expectation is that that can happen any time along the way.

But, as you know, a lot of times these kinds of discussions seem to be targeted much more around specific milestones, like Phase III data or ending data and/or submissions. So, we’ll be evaluating those opportunities as we go.

At that time, should we decide to go on our own, we had made mention and filed previously that we have an agreement in place with inVentiv, which has a collection of sales force – let’s call it resources on hand very rapidly and allows organizations like our own to very quickly put together an appropriate targeted sales force to bring an asset like this to market.

And we’re particularly happy with that type of a group and I’ve been happy with our interaction with inVentiv, in part because the message around this product and for Gimoti is not incredibly technical.

When we meet with physicians in our market research, the concepts associated with non-oral treatment or bypassing the GI tract, it's completely intuitive. So, physicians that have been prescribing metoclopramide for 30-plus years are fully aware of its benefits and its drawbacks. And this eliminates one of the drawbacks.

So, I think it would be seen something as very rapidly utilized within the physician organizations that typically prescribe it, which are gastros. And then, from there, the message delivery from a group like inVentiv can be done very, very quickly, given the simplicity of that message.

We don’t believe it would require anything in terms of a highly, highly technical sales force to put together. So, it’s a kind of a combination of keeping contact with different groups out in the field, which there are many that are looking for GI opportunities.

There have been many different transactions that have occurred in the last several years, in GI space specifically. And from there, if we're moving on, we already have some of the building blocks in place to be effective at bringing this kind of asset to market.

And I’ll also just remark that Dave Gonyer, our CEO had direct experience building these types of targeted sales force organizations and bringing this kind of asset to market. So, we’re not in any way afraid of doing so if it’s the appropriate way to go..

And then just one quick thing, I know that in the past you had provided pretty granular market research surrounding potential pricing and what that impact might have on formulary access.

Do you have any updated thoughts on that or have you conducted the any updated assessment from a market research perspective, especially post the receipt of the Phase III data?.

I appreciate the question. It’s a good one, Ram. We have not published anything new as of late. But I will make a reference to at least one other product in the market that has come out – synergies product associated with irritable bowel syndrome.

I believe they just recently released their branded premium price at around $12 a day, which is pretty standard as a premium price product for the GI space. So, seeing something there or above that, it doesn't seem to be inappropriate at least in terms of what’s being adopted by a number of products in the area.

We have not given any specific direction at all beyond some of the initial stuff that we put out..

Thank you..

No problem..

Thank you. The next question is from Vernon Bernardino of FBR. Please go ahead..

Hi. Thanks for taking my follow-up. My apologies for not articulating very well what I was looking for earlier. One of the things that I’m looking for, given the size of the study, is there any data that you can share? We know some of the preferences and the positioning that [indiscernible] commercialization of the drug that you’ve got from physicians.

But what about quality of life that you’re seeing from the patients? And do you intend to collect some of that kind of data because given Gimoti’s [indiscernible] administration, that’s perhaps going to be biggest points of differentiation from what’s out there..

Vernon, this is Dave. Thanks for that question. Not just I understand completely, but in terms of what we see as the big benefit of this product from a quality of life standpoint is just to be able to get the medication into the body to become effective.

This is a clinical benefit as opposed to convenience benefit for these patient, to bypass their diseased stomach that’s not absorbing food, that’s not absorbing drug.

By bypassing that, we can give the drug, so that it can get the stomach moving and reduce the symptoms of nausea and vomiting, which should help with all products that are taken through oral medication. We saw on our Phase III trial that patients took on average between 12 and 13 different oral medications or different medications currently.

So, we know that they are taking a lot of different oral medication and we don't know – physicians don't know if they're all getting in properly.

Patients either are vomiting them out or many pills are sitting in the stomach and they finally unload in the small intestine and they get these huge spike ups of all the different medications, not just metoclopramide that they may taking for the disease.

So, we see the benefit to the patient of just bypassing that stomach, and that’s payers understand, physicians understanding and we believe patients have begun to understand, especially when they come out of our clinical trial..

Maybe I can add one more thing. Vernon, this is Matt D’Onofrio. If you monitor a lot of the different patient support group blogs and things of that nature associated with gastroparesis, what we've seen is that these patients are very ill and they're not finding the relief that they're seeking just from what’s currently available.

We believe that this will improve that, in part, as Dave was describing, the inability for the stomach to move medications through, so that these patients can find a relief is significant.

And even a specific example that I’ve seen posted on Facebook and otherwise associates with patients who would say, look, I'm taking opiates for the belly pain, it’s so bad.

And their physicians are very afraid that a patient could potentially overdose from taking opiates on a regular basis only because their stomach chooses not to empty until they’ve got three or four or six different pills down in their stomach, which they then all get dumped at once.

So, when you ask questions about a convenience play, we think about this in terms of safety and efficacy and trying to help those patients get more on to a normal life..

There’s the convenience part of it.

But perhaps more fine-tuned as far as the question is concerned because given the – as you mentioned, the synergy pricing, given the managed care’s [ph] sensitivity to pricing these days that if you could correlate, for example, that these patients are able to take less drugs and so on, just other kinds of cost saving, then the really strong data that can be correlated with as far as the clinical benefit that you’ll see and I think that’s very strong, but the outcome as far as the other quality of life factors that the patients are experiencing, is that something you have data already on or maybe you have plans in the future for it?.

That’s a good question. We don't have a lot of data associated with health economic outcomes.

The only thing we can point to currently is that we recognize there’s a number of academic papers and some that are actually noted on some of our presentations describing patients that when they do go to the hospital, which does happen quite often, they are going to the hospital not for a night, but they’re going for a week on average.

And I don't know what the cost you would describe for that, $5,000 or $10,000 per patient day. If you are immediately racking up $50,000 or $80,000 in hospital fees, that doesn’t take long to show a benefit if you can in any way avoid some of that..

Terrific. That’s exactly the direction I was looking for. Thank you very much for taking my follow-up..

Sure, Vernon..

Thank you. There are no further questions. And now I’d like to turn the conference back over to management for closing remarks..

Great, thank you. Let me just end by thanking everybody for joining. You can tell I think from Matt, myself and Marilyn, we’re very excited to move forward with this PK trial and get to an NDA submission.

We’ve worked closely with the FDA over the last several months and years as well and I think we’re all eager to get this product in the market to help these patients. There’s a tremendous need out there for a drug that will help these patients a little bit better than what is available now.

And we’re working hard and fast to do that and be the first company to get out on the market to help these patients who are in such desperate need. So, we look forward to providing some more information here in the next few months and it should be a very exciting time over the six months to end of the year for the NDA. But again, thank you very much..

Thank you. Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time and thank you for your participation..