Good morning and welcome to the Discovery Labs Third Quarter 2014 Business Update Conference Call. All participants will be in a listen only mode. (Operator Instructions) Please also not this is being recorded. I would now like to turn the conference over to Will Roberts, Head of Investor Relations. Please go ahead..

Thank you Nicky and good morning to everyone for joining us today on this call. Today’s call is to discuss the 2014 Third Quarter Financial Results, as well as Discovery Labs' recent business update. Before we begin, I want to remind you that today's conference call will contain forward-looking statements.

These statements relate to future events or the company's future financial performance.

Such statements are subject to certain risks and uncertainties, which could cause actual results to differ materially from any future results expressed and/or implied by such statements, especially those inherent in the process of discovering, developing and commercializing our products.

Listeners are cautioned to not rely on these forward-looking statements, as actual results could differ materially from those described as a result of a number of factors, including those set forth in our 2013 annual report on Form 10-K and any subsequent SEC filings.

On today’s call and available for Q&A after the call are John Cooper, our Chief Executive Officer; Steve Simonson, our Chief Development Officer; Tom Miller, our Chief Operating Officer; and John Tattory, our Chief Financial Officer. With that, I'll turn the call over to John Cooper.

John?.

Thank you Will, and good morning, everybody and thank you for participating and using your time to sit in on our call.

One of things I think is always important when we start of our call and that something I know I do consistently, which is always try to keep providing contacts to what it is that we are accomplishing, what our goal is; and our ultimate goal is to apply our technology, our care for surfactant technology and our aerosol delivery technologies and ultimately do our best to transform the management of preterm infants with respiratory distress syndrome.

Take the learnings from that process and also apply that technology to other respiratory indications where we believe that surfactant deficiency plays a significant role in that respiratory problem. We believe in our technology, we are working hard to evolve this technology, to improve this technology.

We are working very hard to make sure that the products that we have that are in the market are understood properly by the community and help the community. We are working very hard to design clinical programs that ultimately we will achieve our goal.

With that said, we know the market we are going into has been dominated in the past by animal-derived products. We also know that that market has been complacent. Again we believe the technology we have has the capability over time to begin to transform that market.

More important that “a market” it’s patient lives, it is the ability to improve the medical practice and we believe we are on a path towards doing that. With that said, recently we entered into a collaboration with Battelle.

As you know one of the primary goals of our company and I know that the investor community and the strategic community and most importantly, the healthcare community is extremely interested and enthusiastic about the ability to deliver an aerosolized surfactant to the lungs of a premature infant with the hopes that that surfactant in the lungs of that infant will ultimately be able to address respiratory distress syndrome, reduce, if not eliminate the need for innovation and advance therapy in this area.

An area as I’ve mentioned before, where therapeutic advancements have been far from being capable and happening.

We announced in October an arrangement with Battelle as most of you may know Battelle is, we believe the World’s foremost authority in the world of aerosolize or aerosolization drug delivery technologies having a very, very impressive track record over the years in developing the technology that we’ve been working close to with them.

We are happy to have them on board, we are happy to truly have them as a partner where we can truly improve the ability of our company to have device technologies that is so important to what we want to do with AEROSURF.

That partnership that we have with Battelle is geared towards advancing our capillary aerosolization generator that we currently have used in our Phase II program for AEROSURF and advancing that toward ultimately being a commercial device.

The emphasis behind the program is to improve the capabilities, do continued market research around creating this commercial device, sharing the cost and the development and risk and importantly for us Battelle still has the opportunity to enter into many types of arrangements but chooses very, very few every year, and from our understanding maybe one per year, which is to work in this very exciting program.

And with that said, the reward that they ultimately get other than of course the medical advancement that we all believe in is tied to milestones and tied to ultimate revenue generation for their return. So, we are pleased to bring Battelle on as a member of our strategic alliance family. Today, what we are going to cover is Dr.

Miller will be addressing our current progress with respect to SURFAXIN, we are currently now in 17 hospitals where SURFAXIN is being applied and Dr. Miller will get into more details with respect to that.

What we are also going to cover and predominantly I’m sure where most of our questions and most of the discussion will take place today will be the current status of our AEROSURF Phase IIa program. Let me be very clear about our feelings, as well as I am sure your feelings as well.

We are not exactly thrilled by the fact that we are pushing back the timeline from the fourth quarter to the first quarter of ‘15 with respect to one we believe this arrangement will be or the trial will be completed, but I can assure you that we have done extensive analysis with respect to how we believe enrollment cycles work and what we understand to be the process for completing this trial.

We have enthusiasm from the community to bring additional size in to participate in the Phase II program, we are doing that, we are making that happen. And what we think today will cover, which is very, very important is, given where we are today and what we believe to be are the defined boundaries for what we can speak to with respect to the trial.

Remember again, the trial is not completed, but what we are going to ultimately do is do our best, to share with you our learning’s to date and very important, remember this is an innovative product. We are placing a new trial in this area where we do not have precedence that we can look to.

This is the very first clinical program of its kind to go after this very important advancement in medicine. We are learning from it, we are applying those learning’s to future trials to future applications of what we want to do, it is very important that we are steadfast.

It is very important we deliver it, it is very important we learn from the process not only from our operational mistakes, but also from the opportunities that are ahead for us. So, with that said I’m going to pass the discussion on to Dr. Steve Simonson who will then take us through the AEROSURF program.

Steve?.

Thanks John and good morning to everybody on the call. As John was saying, we are working toward of our goal of substantially changing neonatal care for premature infants born at risk of RDS with AEROSURF.

Today, it is well recognized throughout the neonatal community that endotracheal intubation and subsequent mechanical ventilation increases the risk of lung disease and complications in premature infants. Despite that, today there is no alternative to intubation as the means of delivering surfactant replacement therapy to these babies.

Nasal CPAP is increasingly being used as the primary means of supporting these infants, it’s another word to not intubating the babies right off. Despite the fact that up to 70% of pre-matures will receive CPAP alone, will fail and go on to require intubation and mechanical ventilation.

So goes without saying that if can we turn nasal CPAP into the delivery mechanism for surfactant to moving one other reason for intubation, we will go a long way toward not only improving neonatal respiratory care, but also making it much easier for respiratory therapist and other neonatal ICU professionals to deliver surfactant and in short that’s the goal of AEROSURF.

It is an exciting program and a transformational approach and I’m really happy to working with the world class organization both inside Discovery Labs and beyond Discovery. In addition, to our own excellent team, Battelle our tremendous partner for us and have already improved our device manufacturing Acumen dramatically.

Additionally, I am thrilled to be working closely with experts in the field of neonatology on our steering committee and with Dr. Jan Mazela, our new special medical and scientific advisor in neonatology and a global opinion leader in the field of aerosolized surfactant delivery for neonates. We introduced Jan in detail last week.

These highly claimed advisors are tremendous asset to us bringing their expertise in neonatology, respiratory distress syndrome, clinical trials in this population and in the field of aerosolized surfactant delivery in newborns.

Their interest and that of many others in this approach to surfactant delivery is not surprising because if it’s successful it will enable our neonatologists to support a much larger population of pre-term infants with nasal CPAP, while at the same time providing them with the surfactant these infants need to treat RDS, plus increasing the risks associated with intubation and mechanical ventilation.

Moving into our ongoing IIa study and as a reminder the primary goal of this study is to demonstrate safety and tolerability of aerosolized KL4.

We will also be looking for indications of our response to treatment and if successful we can advance to the Phase IIb study where we will work to demonstrate physiologic and clinical evidence of the therapeutic effect of aerosolized KL4 in infants ranging from 26 to 34 weeks of gestation.

These studies will allow us to properly design a pivotal Phase III safety and efficacy study. John mentioned the change in timing for the Phase IIa data and I want to walk you through that. As most of you know, we’ve been conducting the IIa study in four key centers in the United States.

The team discussed on the Second Quarter call that we have begun and have since completed work to amend our Phase IIa protocol to increase the gestational age inclusion criteria from 29 to 32 weeks to 29 to 34 weeks of gestation. And that we had also expanded the number of patients in the study from 36 to 42.

The rates of enrollment in this study have been inconsistent over time and between sites, some greater than expected and some below expectations, but overall where we are today is a [recruitment] (ph) rate that’s slower than our expectations.

In addition to the IIa work that’s been going on we’ve been preparing for the IIb program, including operational activities and identifying potential clinical trial sites to include in the IIb study. This work has enabled us to identify four new clinical trial centers to bring on board now to help us bring in the IIa study.

These centers are nearly on board and by the end of November we will have eight sites enrolling. Upon completion of the IIa study all of these sites will be poised for a rapid transition to the next study in the program.

With respect to additional progress in our ongoing study, this is an open label study, so we have some visibility into selected outcomes of premature infants participating in the trial. I won’t go into detail on any topic, but I do want to give you an update. First of all, the infants are tolerating the aerosol administration well.

Aerosolizing surfactant is no easy fee. We have our proprietary capillary aerosol generative or CAG to effectively aerosolize surfactant. The CAG device itself continues to perform well and sites are comfortable with it. It continues to produce a predictable consistent aerosol stream over variable periods of time required by our study.

Additionally, our investigators have observed that some infants after treatment with AEROSURF are showing evidence that suggest aerosolized KL4 surfactant is getting into the lung.

Regarding safety, this is a very fragile population, so as you would imagine safety is evaluated in multiple settings at the site itself with the investigator and care staff through our own pharmacovigilance system and with an independent safety review committee who are our foremost advisors as it relates to patient safety.

In both treatment groups we have observed known complications of prematurity expected in this patient population. Pneumothoraces are one of the known complications of prematurity in this population. Pneumothoraces are in air leak or in abnormal collection of air around the lung.

These are commonly seen in respiratory distress syndrome and we have seen numerically more pneumothoraces in the AEROSURF group, but the rate is within what has been reported in the medical literature for this population. Otherwise, the general adverse event profile of the AEROSURF treated group is comparable to the control group.

These data have been reviewed with our medical advisors, expert consultants and safety review committee members and they will continue to do so as the trial proceeds.

With respect to timing, after reassessment of the clinical plan our timelines for the program has been readjusted for the completion of the IIa study to the first quarter 2015 and the IIb trial is related to complete in the first half of 2016.

But we continue to be enthusiastic about what we are seeing in the clinical trial, we are adding sites ahead of the Phase IIb study and assuming success in our ongoing Phase IIa study, we intend to be in full sprint when we initiate it early in 2015.

With that I’ll turn the call over to Tom Miller, our Chief Operating Officer, Tom?.

Thanks Steve. Good morning everyone. Transitioning now to surfactant, the third quarter of 2014 was another quarter of progress and the positioning of our KL4 surfactant platform powers us in the United States. Tangible progress as I’ll take you through, but as I’ve indicated in multiple calls, very calculated and deliberant.

We are indeed seeing traction in the US market for surfactant. It’s important to recall that surfactant is a relatively new concept to these institutions, and as John described earlier, it’s truly the first meaningfully differentiated product in a historically undifferentiated market.

If you recall our previous discussions regarding the desirable attribute of surfactant, the product is differentiated from other products in a meaningful way, specifically relating to clinical outcomes, rate of survival, rates of infant reintubation, observations related to those morbidity risk productions and the product appears to have some unique mechanistic of differences, resistant to an activation, and of course it is the first synthetic peptide-containing surfactant category.

As a reminder regarding our core strategy, we have a very targeted and focused universe of institutions that we refer to as centers of excellence and the goal is to really focus on these institutions, first, recognizing that these centers have tremendous influence regarding satellite institutions regionally and nationally.

Regarding formulary acceptance, we ended the third quarter in 17 institutions either on formulary or allowed restricted use within the facility compared to 2013 at the end of 2Q. As expected, summer months, slow in hospitals.

This is the time of the year where there is significant turnover of house staff in various institutions including members of the pharmacy and therapeutics committee. As we move into 3Q and ultimately 4Q, we will see that move back to normalcy.

As a result we expect many of those team meetings that we had anticipated upcoming to now be scheduled in the fourth quarter and first quarter of this year with several secured in our calendars today.

We also are now beginning to see significant signs of re-ordering in a number of accounts, which help us deliver the quarter-over-quarter growth that John Tattory will describe in detail in a moment.

We have also begin to focus significantly on 2015 with a key theme of aggregation of business, specifically meaning that as we get good experience in the central institutions, we can use this as a strategic tool to aggregate business and related facilities across larger healthcare systems.

Insist on the product remains strong and despite the challenges, the historical challenges that we have mentioned and really laughing down timing for a P&T meeting to actually have the discussion that we want to have, our success rate at the P&T meeting remains quite high.

We continue to see success in being added to formulary and over 75% of P&T meetings that occur, a first time growth, and we’re happy to see the trend continue.

And combined with the fact that our facilities are getting comfortable with the uniqueness of SURFAXIN, the way it’s prepared, the way it’s delivered, we believe that this bodes well for future continued growth of the products.

We continue to build the dates of SURFAXIN (indiscernible) that over time we certainly hope will become AEROSURF (indiscernible) for our organization.

And as we match this data in this favorable experience, it sets the stage for being able to capture this data from these institutions regarding contemporary use of the product, which is ongoing as we see, and the opportunity to amass evaluate and potentially release these data as we move into 2015.

The last two months of the year for us are very important as it relates to our customer facing initiatives, essentially because the fact that there are two very important scientific and clinical meetings in the last two months of the year, in November and December.

The American Academy for Respiratory Care AARC meetings, the largest respiratory therapist in United States, in fact the world, and hot topics in hematology meeting is a premier neo-natal medical conference, the most concentrated attended meeting of neonatologist both within and beyond the United States.

Regarding the latter this year, we are supporting a symposium, concurrent and future practice of management of respiratory distress syndrome, topics will include the changing definition of surfactant administration, recognizing that there is a very, very high unmet need for lucinactant solutions, most notable aerosolized surfactant, mechanistic differences, notably aerosolized surfactant, mechanistic differences between surfactant, and what this might mean as it relates to clinical application of these therapeutics, very, very specifically focusing on differences between synthetic and animal-derived surfactants, and current and future trends in mechanical ventilations for newborns, which is obviously a very relevant topic for us as we advance the AEROSURF initiative.

We expect to see several hundred participants in this venue followed by a much larger opportunity through support of continuing medical education credits (indiscernible) venue. So with that, I will turn the call over to John Tattory to detail financial results for the third quarter.

John?.

Thanks Tom, and good morning everyone. As Tom mentioned, we saw continued progress in growth for surfactant during the third quarter. Sales through our specialty distributor were $219,000, representing a 92% increase over the second quarter.

The demand sales or sales to the hospitals to meet the needs of our patients grew approximately 60% to $116,000 compared to $72,000 in the second quarter.

As a reminder, we use the sell-through method of revenue recognition, which means sales through our specialty distributor are deferred until the distributor sells product through to the hospital and all other revenue recognition criteria are met.

Based on this policy, we recognized $106,000 SURFAXIN revenue in the third quarter compared to $42,000 in the second quarter.

In addition, during the third quarter, we received $421,000 of $1.9 million NIH grant supporting our AEROSURF Phase IIa clinical trial and expect the remaining $400,000 available under this grant to be received in the fourth quarter.

In addition, we were recently awarded $1 million SBIR grant from the NIH to support the development of our aerosolized KL4 surfactant as a medical countermeasure to mitigate acute and chronic to late-phase radiation-induced lung injury. Over the next three years, we may be awarded up to an additional $2 million as part of this grant program.

The rewarding of this grant speaks the interest among the medical and scientific communities and identifying other indications in which KL4 surfactant potentially could be used. We will begin drawing on this grant in the fourth quarter. Operating expenses for the third quarter were $10.9 million and consistent with the comparable period in 2013.

Operating expenses in the third quarter of 2014 reflect continued investments supporting our AEROSURF development program including conducting the Phase IIa clinical trial and beginning to manufacture capillary aerosol generator devices for the anticipated Phase IIb program.

In addition, we continue to invest in medical affairs programs in order to communicate the key scientific attributes of our KL4 surfactant. From an overall operating standpoint, we reported an operating loss of $10.3 million for the quarter compared to an operating loss of $10.8 million in the third quarter of 2013.

Regarding our cash position, the third quarter operating cash outflows before financing activities was $10.6 million, and we ended the third quarter with approximately $55 million in cash and cash equivalents. For the fourth quarter of 2014, we are anticipating an operating cash burn before financing activities of approximately $11 million.

And finally we have $30 million outstanding in the secured loan with Deerfield. As a reminder, the loan is due in three equal annual installments beginning in February 2013 and the 2017 and 2018 installments can be differed if we meet certain financial milestones. With that I will turn the call back over to John Cooper for closing Comments..

Thank you John, and again, thanks everyone for your time to listen. In general I know most of the questions that we are about to get into will be focused on AEROSURF, and one way of how we look at this right now is we are now into the second half of that program.

We are adding the sites that we need from the Phase II preparation into this program, so we will be working very diligently to bring this program home.

The investigators on the sites are enthusiastic about what we have been experiencing so far, and if we look at this as an interim report, we believe based upon the discussions that we’ve had with our steering committees, our safety committees and all of the advisors that we have that as of this moment, we would be in a situation where we could say so far that we have a product that is safe, well tolerated and we are beginning to see signs of deposition of drug into the lung.

I think that’s where we are as of today, now keep in mind we have to complete the studies, we have more data. So by no means is what I am saying a final result of course. But nevertheless it is an interim look as we see things so far. So with that let me move it on to – let me pass it on to the operator for Q&A..

(Operator Instructions) Our first question comes from David Amsellem, Piper Jaffray..

Hi, guys, this is Trevor Davis on for David, thanks for taking the questions, just a few.

So, just on AEROSURF and what type of top line metrics from the Phase IIa study do you guys expect to disclose in early 2015? Then I guess, is the initiation of a Phase III program for AEROSURF, I guess assuming that there is positive Phase II results fill a realistic expectation for let’s say late 2016 or do you think that will essentially be pushed to 2017? Thanks..

With respect to the latter part of your question the answer is yes. Given what we know today and given the timelines that we have with respect to the Phase II program, I could say that there is still an expectation that towards the latter part of 2016 we could be anticipating a potential Phase II experience, and at the beginning of that.

Now with that said, the first part of your question was what kind of I guess metrics will we be delivering, well to be determined as we begin to assess what we have our goal is to be as robust as we possibly can, but also keep in mind the goal of the program, the ultimate goal of the program is the drug safe, is AEROSURF safe and well tolerated.

If that is positive then we move forward. Now, the next question is, what everybody I know wants to understand is what are the comparisons versus controls, what are the comparisons versus that information.

We’ll decide as we understand what that’s going to look like, but what we really need to do is make sure that get a get a go ahead to move into the Phase IIb, and as I mentioned earlier the other expectation that you should have with respect to the program is, I think critical hand-in-hand with safety, which is as of right now in order to assess what Phase IIb would look like, we need to know it’s safe, well tolerated and is there evidence, are there observations to of course measurement of whether drug is getting into the lungs of these children.

Remember what is happening, again, I always have a broken record, but I always use the word context please put everything in context with 25 years the way drug has been delivered, the way surfactant has been delivered to babies is through intubation.

Or there have been a number of, I’ll call them experiments where people are trying to take off-the-shelf nebulizers. Hopefully aerosolize an animal-derived surfactant, which is a very, very difficult process giving viscosity and giving proposition of surfactants, and see if that can develop an aerosol.

We are the very first to take a sophisticated aerosolization technology that has been designed specifically for surfactant delivery, to combine that then with the approach of delivering it to the lungs of a baby.

So to us in the world of trying to move this medicine forward that’s a tremendous accomplishment if we can judge safety, tolerability in this study, and some evidence that drug is being depositing into the lungs, if we do that now we go forward, now we enter into our Phase IIb program and the remainder of Phase II program to really now get an understanding of some efficacy signals that we will be looking at, that’s the expectation we should have in mind..

Great. Thanks, it’s helpful. Just one quick question on SURFAXIN. So maybe you could just add some color around those, the formulary access, so you mentioned that you have access now at a total of 17 neonatal critical care facilities. So I guess – and then I think that’s a net increase of 2 this quarter I think it was 5 the previous quarter.

So I guess the question is how many additional facilities are you targeting for formulary status and where could we see this number sort of evolve to 2016?.

This is Tom Miller. Good morning, and thanks for the question. So just a reminder as at the close of last quarter we’re at 13 facilities, by the time we got the call 15 and now 17 for the status at the end of this quarter.

As we move into fourth quarter, we will expect continued growth in a reasonable direction going forward, but we have not provided quantitative guidance in a forward looking fashion as to what that will look like.

As it relates to the first part of your question, which I think was a little bit more qualitative, the challenge that we have is really just the initial scheduling because as you might expect we’re not the only product that’s being considered as formulary at any given time.

The half of the formularies are routinely making decisions regarding 100’s of therapeutics at any given moment, so our job is to really try to get the neonatology team as engaged as possible so they can try to do their best to help facilitate our positioning in the [queue] (ph).

Early on, earlier this year we had indicated that there were certain circumstances where we thought that we had secured that initial date and that date – two or three meetings at a given time, there was one facility that took us five separate times to secure that team meeting.

The alternative position that I shared with the group this morning, in fact we continue to see a very high success rate more than 75% when we actually get (indiscernible) SURFAXIN and expect that to continue going forward. So hopefully that clarifies your question. Let me know if you have anything else that I could help clarify..

Absolutely that was helpful. Thank you so much guys..

Thank you. The next question is from Scott Henry with Roth Capital. Please go ahead..

Thank you, and good morning.

I guess just to keep it on SURFAXIN before switching it over, I guess one of the questions that I was wondering is, which is very similar is the 17 is the numerator, what should we think about the denominator, you know 17 out of how many? And as well as any color on how you are doing within in some of the key thought leading formularies?.

Scott, you may recall, this is Tom again.

Maybe a two calls ago we introduce this concept of centers of excellence, which is our primary focus, there are you know although different groups may have different definitions of these type of hospitals, we view that the right number with respect to the ability to convey that info into about 30 institutions in the United States.

When you look at these institutions they are typically often times not a single hospital, there may be one central hospital where they have that international reputation, but there may be a good number of satellite institutions that surround that group. So we in general view that universe at about a –about a 150 institutions that have relevance.

And as I indicated in our prepared comments, in other words, now that we’re starting to have those good positive robust experiences in a number of these core institutions, the idea now is to try to leverage that experience and aggregate that business.

Can we contract across the entire system now that we have advocates take go beyond just, I am familiar with the data, but now we’ve had good practical and pragmatic experience with the product, and that’s really the next leg of strategy for us.

To maybe go one step further the denominator to the denominator is really only about 400 facilities in the United States in its entirety that really matter from a demand generating perspective, but we have a small team very focused on the strategy, and our goal is to just continue to chip away at the progress as we’ve have done so far..

Thank you, that’s helpful.

And then in the bigger picture, I mean obviously you’re making progress and that’s the important thing, but I think investors are – want to get an idea of when you could think there may be an inflection point? And if we think about inflection point selling at least $500,000 in a quarter, when do you think we may start to see those early signs of that inflection point?.

Yes, that’s a good question.

What we’ve done is we’ve looked at analogs as well, we’ve looked at other surfactants, we’ve looked at other products without inflection point, the specialty products where there is an animal-derived product out there to begin with and then a recombinant or a synthetic comes in, what we’ve have seen normally is that inflection point taking place around a two-year period post launch, which means it’s pretty consistent, we think that’s a consistent way of looking at where we are as well..

Okay, thank you for that..

So Scott, that’s – we are talking towards this time next year..

Okay, great. Shifting gears to AEROSURF. I just wanted to dig in a little bit about this issue of, I think you referred to it as collection of air around the lung.

Could you tell me – first of all, do you expect you would see a statistically significant increase in that event? And perhaps if you could just give some color, what does that mean clinically, how much of a factor is it when treating these babies?.

The pneumothoraces or air leak around the lung is a recognized complication of the respiratory distress syndrome, and one would not expect to see a statistically significant difference in that, and in fact this is something that we would expect to be improved as we get surfactant delivered to the lung..

Okay, so will you clarify this as a transient side effect?.

This is a serious, but manageable side effect in the respiratory distress syndrome, and it is one of the complications of prematurity that will be following throughout the program..

Okay, I guess another question, obviously Battelle just made a significant investment in this technology, where they aware of these issues prior to making that investment?.

Battelle and us we have a partnership, and I am not going to sit here and share the efforts that they went through to get here, but we share with them what’s necessary to make sure that they’re constable in order to make their investments and to move forward..

Okay, fair enough. I am just trying to get my arms around it, this issue. But thank you for that color and thank you for taking the question..

You’re welcome..

Welcome Scott. Operator (Operator Instructions) Our next question is from Tom Shrader with Stifel. Please go ahead..

Good morning, if I can go back to pneumothorax.

Is that consistent with the mechanism of AEROSURF that you are maybe quickly activating damage lung tissue, and might you expect to see that? And is it ever seen with regular surfactant administration, the conventional method?.

Tom, this is Steve.

Yes, it was seen in much greater numbers in the pre-surfactant era and it has been seen – and if you know all of this, surfactant labels, surfactant therapy tends to reduce the complications of pneumothorax and what we are seeing in this situation anecdotally maybe evidence that the surfactant is getting into the lung and setting this up..

So net-net, you would expect pneumothorax to be down, if your drug is working correctly or maybe up if your drug is working correctly?.

Pneumothoraces are a serious and manageable complication of the RDS respiratory distress syndrome, and this is something that we would not expect to be increased in our program..

And are you seeing any correlation with any dose or not enough signal to have a sense yet?.

At this point in time, it’s too early to comment on that..

Okay, and in terms of the enrollment issues, are you fining involvement is clustered that some physicians get comfortable with this and enroll a lot of patients, or is it kind of uniform and just a little slow everywhere?.

We are absolutely saying more of a former, I don’t know if I would say comfortable situation, (indiscernible) with the product, we have sites that are exceeding the expectations and then we have other sites that are not – every site is different as you could imagine, in their practice and in their application.

In many ways, Tom if we have to look at hindsight of being 20/20, we would have added more sites earlier to take into consideration of the fact that some sites are going to be (indiscernible) and other sites just may be driven in 1 or 2 patients over time, but we are seeing inconsistency among the sites..

And just one last question, do you think the improved device, which is going to be easier to set up, easier to understand, could that have a big effect, is that consistent with the problems and enrollment and maybe the pre final devices is just a little intimidating?.

No, actually we are finding that all sites are comfortable with the existing device..

Okay, thank you..

Thank you. As there are no further questions, this concludes our question and answer session. I would like to turn the conference back over to Mr. Cooper for any closing remarks..

Okay, thank you everybody, I would really appreciate your time. We will be doing our best to make sure we keep you up to speed on the advancement of both SURFAXIN and AEROSURF and hopefully we will be doing that shortly. Thank you very much for your time..

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines..