Good afternoon and welcome to the AcelRx Pharmaceuticals, Q3 financial results conference call. All participants will be in a listen-only mode. (Operator Instructions). Please note that this event is being recorded. I would now like to turn the conference over to Tim Morris. Please go ahead sir.

Thank you Chad and good afternoon everyone. Welcome to today’s call. On Today’s call I’m joined by Richard King, Chief Executive Officer; and Adrian Adams, the Chairman of the Board. On today’s call, we will provide an update on the activity since the receipt of the Complete Response Letter or CRL for Zalviso that we received on July 25, 2014. We’ll discuss the progress on the European regulatory approval of Zalviso. We’ll provide an update on ARX-04. We’ll review the financial results for the quarter and nine months ending September 30, 2014. We’ll update our financial guidance for the remainder of 2014 and lastly, we will take your questions. During the call today, we will make forward-looking statements, including but not limited to the company’s Zalviso NDA and the CRL; our plans to address the issues raised in the CRL; our anticipated resubmission of the Zalviso NDA to the FDA, including the scope of the resubmission, the timing of the resubmission and the FDA review time; planned initiation of the Phase 3 clinical trial for ARX-04; the therapeutic and commercial potential of AcelRx Pharmaceuticals product candidates, including Zalviso; statements related to future financial results, including 2014 financial guidance and cash forecasts; potential milestone and royalty payments under the Grunenthal agreement; the process and timing of the submission of the Marketing Authorization Application or MAA and the CE registration in the EU; and the status of the collaboration agreement with Grunenthal or any other future potential collaborations. These forward-looking statements are based on AcelRx Pharmaceuticals current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include without limitation, risks related to: AcelRx Pharmaceuticals ability to receive regulatory approval for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product candidates, including Zalviso in the United States and Europe; our ability to obtain sufficient funding to commercialize Zalviso and proceed with the clinical development of ARX-04; the success, cost and timing of all product development activities and clinical trials, and other risks detailed in the Risk Factors and elsewhere in AcelRx Pharmaceuticals U.S. Securities and Exchange Commission filing and reports, including our Quarterly Report on Form 10-Q filed with the SEC on August 11, 2014. AcelRx Pharmaceuticals undertakes no duty or obligation to update any forward-looking statement contained in this release as a result of new information, future events or changes in its expectations. I will now turn the call over to Adrian Adams, the Chairman of our Board of Directors.

Thank you Tim and good afternoon everyone. The company has asked me to join the call today on behalf of the Board of Directors to comment on the announcement made last week of the departure of Richard King, the company’s President and Chief Executive Officer. The decision made by the Board of Directors was not made lightly and it reflects our strong desire to seek a President and Chief Executive Officer with a proven experience and capabilities to take the company into the next and most important phase of its evolution. The Board of Directors has initiated a search for a new President and Chief Executive Officer and we are pleased that Richard has agreed to remain with the company as President and Chief Executive Officer while the search is ongoing and until the new CEO is in place. Speaking for the Board and the whole company, we sincerely thank Richard for his significant contributions in leading the company to this point, including his transition to a public company, multiple capital raising transactions and important partnering transaction with Grunenthal, and the Zalviso and ARX-04 clinical developments. Finally, I and the Board would like to emphasizes that we remain confident about the Zalviso and ARX-04 development programs, the work that is being done towards a timely resubmission of the Zalviso NDA in the first quarter of 2015 and last, but certainly now least, the potential for this company to create significant shareholder value. With that, I will now turn the call over to Richard for a discussion of the business activities and to provide a regulatory update on Zalviso.

Thank you very much Adrian and I’d like to thank everyone for joining us this afternoon for this call. I plan to address the progress for the Zalviso in the U.S. and in Europe, progress on the patent front and provide an update on status with ARX-04. As we have previously discussed, in the U.S. the FDA issued a Complete Response Letter or CRL for the company’s NDA for Zalviso. The CRL contains request for additional information on the Zalviso systems to insure proper use of the device. The request includes submission of data, demonstrating a reduction in the incidence of optical system errors, changes to the instructions for use for the device to address inadvertent dosing and submission of additional data to support the shelf life of the product amount other things. At the end of September we held a teleconference with the FDA to review our proposed response to the Zalviso CRL. Prior to the meeting we have provided a briefing document outlining plans for our response to the aforementioned mentioned issues in the CRL. During the teleconference with the FDA, we confirmed that bench testing could be an acceptable approach to evaluate the reduction in optical system errors, subject to Agency agreement with the test protocol and the target optical system error rate. We plan to submit the bench test protocol to the Agency for review and comment shortly. The protocol will clearly delineate all plan changes to reduce the optical system error rate, including addressing specific questions raised by the Agency in its written response to the company’s proposal. To address the risk of inadvertent misplacement of tablets, we propose mitigations through the Zalviso systems and IFU, and to test these mitigations by way of a human factor study. The protocol for the human factor study…

Thank you Richard. For the third quarter of 2014 we had a net income of $671,000 or $0.02 basic net income per share or $0.13 on a diluted net share. This compares to $11 million net loss or $0.26 basic and diluted net loss per share for the third quarter last year. Net income in the current quarter as compared to net loss in the prior year quarter was primarily due to an increase in revenue from the receipt and recognition of the $5 million milestone to payment for the MAA submission under the collaboration agreement with Grunenthal, and non-cash income from the reevaluation of the PIPE warrants issued in connection with the PIPE financing in June 2012, partially offset by an increase in operating expenses. Changes in the valuation of PIPE warrants are recorded to the other income or expense line item in the P&L. During the third quarter of 2014, the change in value of the PIPE warrants resulted in other income of $6.4 million for the quarter, whereas the change in fair value of the PIPE warrants in the third quarter of 2013 resulted in other expense of $2.4 million for the period, a positive swing of $8.8 million. As a reminder, this is a non-cash charge. Financial performance maybe better measured by looking at the income or loss from operations. The loss from operations of $5.1 million deceased in the third quarter of 2013 compared to the loss of $8.3 million in the third quarter of 2013. The decrease in the operating loss was due to lower research and development expenses, primarily due to reduced development work to support the FDAs review of the Zalviso NDA, partially offset by higher general administrative expenses, primarily related to precommercialization efforts towards Zalviso. For the nine months ended September…

Thanks Tim. I’d like to now open the call for questions. So Chad, I’d like to turn it back to you so you can coordinate, I’d appreciate it.

Certainly. (Operator Instructions) Our first question comes today from Louise Chen with Guggenheim. Please go ahead.

Hi, thanks for taking my questions. I apologize in advance for the awkwardness of asking these, since Richard you are on the phone, but there has been a lot of controversy surrounding potential replacement for you. And I was curious, first of all myself and others have thought that you’ve done a great job with the company. So curious specifically as to why the Board’s decision to change the CEO now and then the timing obviously is controversial given that you are ahead of resubmission. So I’m wondering, why not do the resubmission and then look for somebody, and there hasn’t been a replacement announced, before they announced that there was going to be a change. So that’s obviously drawn a lot of concern from people and so maybe I’ll stop there and see if you could any answer of these question. Thanks.

So Louise, firstly, thank you for the comments. By why don’t I turn that question over to Adrian to address it.

Yes, thanks Richard and thank you for the question. Clearly I think decisions like this are never easy. I think in taking this decision, this had nothing whatsoever to do with any concerns in relation to the operations of the business and very importantly any concerns in relation to the work that was been done in anticipation of the resubmission of the Zalviso in the first quarter of next year. It had everything to do with looking to make sure that as we move through the course of 2015 and beyond that we had a CEO in place with the proven experience and success and the capabilities to take this company to the next level. We are delighted of course as I mentioned that Richard has agreed to stay on until we secure that new CEO and we anticipate that to be obviously in the first half of next year. With regard to the timing, obviously as I mentioned, I think decisions like this are not made in a light fashion and most centrally I think there has been a tremendous amount of work that has been done to-date and is being done as we speak, to make sure that there are no kind of issues in relation to timing of the resubmission. And clearly I think one of the reasons we are very pleased that Richard has agreed to stay until we get a new CEO is to ensure that things are done in a seamless fashion, so. And with that I’ll turn it back to Richard.

Okay, does that address you question Louise.

It does. Maybe if I could just push a little bit more. So I mean, I was always under the impression that Richard you were experienced and have successfully launched products and run companies. So I guess maybe I’m curious as to specifically what that Board is looking for in a new CEO, that maybe if that you could give more specifics around that.

I mean, you are (inaudible) the management team at AcelRx. I think we have a very good quality management team and they are all kind of contributing in many different areas and most certainly I think everyone looks at the track record to date in relation to what has been done. I’ve already commented on, I think most certainly the company has moved to a very nice stage. That said, I think it is our responsibility of a Board of Directors, given the very significant shareholder value creation here just to make sure that as we move into the next very exiting phase of the company, that we have that skill set and proven successful experience to take us forward into the next phase. And more certainly I think this had nothing to do with any disagreements between Richard and the company or indeed any matters related to the company’s operations. And so clearly I think we are in a good situation as we are at this particular point in time and this had everything to do with making sure as a Board of Directors we have everything in place and to put ourselves in a very strong position to increase shareholder value over the course of time.

Thank you very much.

Thank you very much for the question.

The next question comes from Randall Stanicky with RBC Capital.

Great, thanks guys. Let me ask this another way. As you move towards commercial approval, what else do you need from a management perspective? I’m just thinking about from a Chief Commercial Officer or other people in that place. Thanks.

I mean clearly I think everyone looks at the kind of the broader aspects of capabilities and proven experience. I think we recognize that the commercialization of Zalviso subject to FDA approval is of fundamental importance, and clearly as it relates to the choice of a new CEO, that particular capability and competency is a very strong component of that. As is the broader general management aspects in relation to building this company, moving forward and we feel that now is the right time for us to look at the next phase of evolution of the company and those are a lot of different components that will come in to the choice of a new CEO and very importantly, and again stepping back to what I mentioned earlier, we are very pleased that Richard has agreed to stay until that new CEO is in place and we will make sure that the decision making and the qualities that we are looking forward in a CEO drive the timelines of that. We want to make sure that we choose the right CEO to take us into the next stage of development.

Got it, and then let me just ask a question, where we are with the process. Have we submitted the protocol to FDA? If not, when would you expect to do that and then how long do you think it’s going to be for the FDA to come back to you. And where I’m going with this, I’m trying to understand if the timing has been pushed back a little bit, if we are thinking about early ‘15 before we understand it, what else we need to do for submission thanks.

Good question. Obviously these protocols are critical documents and we want to get them exactly right. So we are taking every opportunity to review them, both via very careful internal review and also by external review as well. But the protocol submissions for both bench testing and also for human factors are eminent.

Thanks.

The next question comes from David Amsellem with Piper Jaffray.

Thanks. So I guess at the risk of beating a dead horse, maybe I’ll try to ask the question in a differently Adrian. Maybe you can provide specifics on what are the ideal qualities in a new CEO, maybe if you can give us some more color on that. And what exactly would that CEO do that would to be frank be better or different than from Richard could do. Thanks.

I mean, thank you again for the question. I think I’m going to reiterate a number of points, and well certainly I think, I don’t want to get into comparisons of any profile of a new CEO that we will recruit versus Richard. I think that is not appropriate. I think Richard has done a very good job of getting the company to where it is at this point in time. I think just to reiterate, I think the company is in very good shape and I think most certainly we think is a very attractive proposition for a potential new CEO. And most certainly I think given the potential to unlock significant shareholder value over the course of time, we are pretty confident that the identification of a (inaudible) of a new CEO will be of great benefit to the company. I think one reference a deep track record of success and in terms of deep commercial experiences. It is the broader aspects of those attribution capabilities that we think are important as we move into the next phase, I think. And this is nothing to do in relation to any challenges we’ve had to date in terms of where we are at this particular point in time as I referenced in my earlier comments. I think we are very pleased with what Richard has done to get the company to the next level. This is all about putting in place a CEO that has the proven, deep experience and the success and capabilities. Not just commercial, although that is very important, but broadly to take the company to the next stage and I think that is the sufficient comments at this particular point in time.

Okay, let me ask a follow-up of -- if I may just switching gears. How would you comment on the relationship with Grunenthal and there’s obviously been – you obviously updated the CRL and the response pending. Now you have to management change. So is there anything that’s changed in your relationship with Grunenthal given the appeal? Thanks.

So let me comment first off David. The answer is we had a very, very good working relationship with Grunenthal, even since, they have gone up to the signature on the agreement and then ever since that time as well. We work hand in glove with them from a regulatory standpoint as we prosecute the marketing authorization application in Europe and also as we prosecute the CE marketing process for the Zalviso device. I might go one stage further. We have a joint steering committee. Tim, you are on that joint steering committee between ourselves and Grunenthal. Maybe you can comment from the inside of that side of things as well.

Sure. I actually think that Grunenthal is pleased with the progress we’ve made on the filing and the application in Europe as we mentioned before we got our ISO 13485 certification. The next step will be the CE Mark and we are basically on time to have a decision by CHMP in the third quarter of next year. So while obviously the CRL will set back in the U.S. and the change in CEO will be something we’ll have to deal with internally here. I think for the most part Grunenthal still sees the extreme value in the product. They are still preparing their commercial prep and the MA process kind of remains on schedule. So I think they are very satisfied.

Just one – I’ll just add one other thing to that as well, which is that today or tomorrow, I’m not sure which of the two, but there is an expanded board meeting in Germany at Grunenthal and Pam is actually there presenting to the board, to give them full insight to the Zalviso opportunity continues to cement that relationship going forward. So I think that it’s a solid one and its one which is active and dynamic.

Thank you.

Got you.

Our next question comes from Boris Peaker with Cowen. Boris Peaker - Cowen & Co.: Good evening gentlemen. So I just want to probe a little further into the FDA discussions. What exactly is the FDA looking in the bench protocol, as well as the human factor study protocol? I mean I’m just trying to get a sense of how standardized are those and make sure that – understand if there’s going to be a lot more back and forth on something like this or is there a clear template to follow?

Okay. Well, there’s never a template when you’ve got a very specific and very unique product, which is what the Zalviso start off as. Bench testing though is, as its described we basically take systems, we put them through a test protocol on the bench and we look for the rate at which the system produces unexpected optical errors and that’s a fairly standard sort of a process in relation to the work that we’ve done to evolve the Zalviso system to address those optical system errors. So the Zalviso system itself is unique. The process of bench testing is fairly standard and we think they are following all the right and necessary elements to support that bench testing. Similarly as well for the mitigations that have been developed to advert the inadvertent dosing of Zalviso tablet, that 15 tablets in the 30,000 overall that were identified in Phase 3. When you evaluate mitigations that involve instructions for use, instructions for patients and instructions for healthcare providers, you do that through human factors testing; that’s the appropriate test vehicle and again, the human factors test, while its specific to Zalviso, its fairly standardized from a device platform. So we are following those standardized procedures and obviously the specific areas are how effective are these mitigations that have been developed as the subject of very specific elements of the human factors test that are unique to Zalviso. Boris Peaker - Cowen & Co.: I see. And have they testified exactly how will they determine that the human factor study is just a failure. Like what frequency of failure is acceptable?

So that’s part and parcel of the protocol review. We will propose that in the protocol review for the bench test. Human Factors is a little more imprecise from that. You’re looking for the effectiveness of the training solutions that you proposed as mitigations to the issues that you’re trying to address. If those prove to be ineffective, then you go and re-evaluate those mitigations and try and make them effective, so the healthcare professionals and patients could follow them reliably. But that, we believe that the mitigations that we have developed and proposed to test the human factors are going to prove effective and that they will prove to be straightforward for both patients and healthcare professions. The following can be validated through the human factors test. Boris Peaker - Cowen & Co.: Got you. My last question is on the sales force with the kind of the delay in the NDA. What is your strategy in the sales force? Are you making contingent offers? When you delay hiring where do you stand?

Yes, so on the sales side of things, we have four out of seven of our Regional Business Director positions filled. We did no recruit any of our sales and those are the sales managers, right. So the guys that manage the sales team, nice 65 sales representatives. We did not recruit any of our 55 sales representatives were waiting for the approval to go ahead and do that. What we’ll do now is we’ll look towards the resubmission of the NDA and in the six month review clock is that we will prepare contingency offers such that at the time of the approval, the ability to go and move forward, to recruit quickly a sales organization is in place, and that will happen obviously in the latter part of next year. So that’s how we posted it, but at this stage we will retain and continue to leverage the experience of our four institute regional business directors who are evaluating our institutional sales targets to make sure we understand which of those we go to first, so that we can maximize the ramp for the Zalviso introduction. Boris Peaker - Cowen & Co.: Very well. Thank you very much for taking my questions.

Thanks Boris.

Our next question comes from Ed Arce with ROTH Capital Partners.

Thanks for taking my questions. Actually most of them have been asked, but I do have one further. I was curious about your mention that in addition to submitting the protocols for both the bench testing and human factor studies, you will be also providing some evidence that the clinical evaluations of either of these two is unnecessary and I’m wondering, to what degree do you think that is a likely scenario and why do you think that that’s really necessary as part of the submission. Thanks.

Great question, thanks Ed. And again, I’m going to just go back to the CRL for a minute. In the CRL that we received, the FDA was very specific and in that in order to evaluate the mitigations, the inadvertent dispensing of tablets, they identify that human factor testing – they specified human factor testing as being the appropriate test mechanism in the complete response letter and we concur with that. We think that is exactly the right response. At the same time they’ve also invited us to provide for the more rational as to why the clinical evaluation of these mitigations is inappropriate and unnecessary. We’ll do that alongside the protocols and obviously we’ll want to see what comes with that dialogue, but at this stage that’s how we propose to handle things with the agency, to respond to their request for a human factors protocol and also to their request for why clinical evaluation is inappropriate.

Thank you.

Our next question comes from Biren Amin with Jefferies.

Yes, thanks for taking my questions. I guess a couple of questions on Zalviso. Once you submit the bench test and human factor protocols, is it typical for the FDA to respond in 30 days and I’m wondering whether it’s the company summit that it would start the two tests this quarter. Thanks.

Okay, so unfortunately typical its, I don’t think typically its available to us. We think certainly and based on historical elements associated with the Zalviso development program, that 30 to 60 day is not at all unusual or it’s the norm. But we’re in the situation of a CRL, which is why the commentary about the expectation that the FDA will back to us in a timely fashion, but without a specific guarantee that they will do so. So that’s the reason for the hesitancy on saying definitively Q1 for the response to go into the agency. In terms of the protocols themselves, since we have the protocols in hand, we will actually execute those protocols ahead of feedback from the agency. If the agency comes back with comments that modify those elements, then obviously we’ll modify and repeat accordingly, but that’s why we are spending the time to make sure that we’ve covered every aspect that we can do associated with these protocols. So the answer to your question is, we will initiate the work this year, but obviously the picture as to whether that satisfies the agency’s needs will depend on the agency feedback to the protocols themselves.

And Richard, how long do you anticipate it would take to finish those tests?

They are relatively short tests, so the bench test is in the sort of four to six week range. If you impact those tests within – similar actually, four to six weeks, closer to four weeks, that’s the sort of scale of work.

Got it, and then maybe another question on Zalviso. Given Ionsys PDUFA and potential for Ionsys for launch in Q2 of next year, with that influence how the company thinks about pricing for Zalviso?

That’s a good question. So I’ll go back historically a little bit. So Ionsys has priced once before in Europe where they priced at around about $120 or so per patch per day of treatment. That’s certainly a robust price point. As you know it’s at the top end of where we’ve described the IV PCA related costs on a per day basis and yet based on analysis of the premier data set. But that was certainly years ago and that’s designed to develop somewhat since then, so quite where the Ionsys product was priced is ultimately up to anybody to guess. Our valuation for Zalviso will be based primarily on the market, the market opportunity and how we want to approach the marketplace and the ability of us to leverage the Zalviso value against the expectations for pricing the product in the marketplace. Obviously our first and foremost intent is to see Zalviso used as broadly as possible in the institutional setting. We believe it has a significant value to offer to patients, to healthcare providers and institutions and pricing of Zalviso will be reflective of that opportunity first and foremost and secondarily we’ll look at what Ionsys does.

And then maybe a question on ARX-04. What are the key issues that the company meets to complete in order to finalize the DOD contract?

So we have been notified that we have been awarded the grant. There are basically two elements that need to be completed. The first is an agreement with our clinical approach that there’s a human office of approval for protocols that are conducted under DOD grants that has to review our protocols and be comfortable with them. And secondly, there is a negotiation around the actual final value of the contract, reflective of the work that’s to be planned. We applied for this grant some time ago and across in the meantime we’ve continued to evaluate the scale and cost of the ARX-04 program and that discussion is to be held with the DOD to finalize the terms of the contract. So those are basically the two elements, clinical review and the contract review and agreement.

Okay. And then maybe just a final question. I guess this one is probably for Adrian on the CEO search. Does the board have any candidates on deck and I guess in terms of the process, will it be a particular person on the board that’s spearheading the search or is this a decision by the committee?

I think as it relates to the search, we have just initiated the search. I don’t think it would have been appropriate for the Board to initiate a search without having the discussion with Richard. As it relates to obviously moving forward with the search, I think this will be a search that will be done by the Nominating and Governance Committee that is chaired by Mark Wan. I’m a member of that and Steve Hoffman as well. So it will be done by a Nominating and Governance Committee and then we will make recommendations to the Board.

Great, thank you.

Thank you.

Our next question comes from John Newman with Canaccord Genuity.

This is Kevin in for John Newman. Thanks for taking my question. Just playing the devil’s advocate here, in case the FDA does come back to you requiring additional clinical studies, are you prepared for this type of resubmission currently and how fast can you guys respond to the FDA with this resubmission.

At this stage I would say the agency has requested a rational for why clinical evaluation, the mitigations that we proposed to test the given factors is inappropriate and unnecessary, so lets assume, because again there’s no guarantees in this life, lets assume that they came back and said, okay we’ve decided that the human factors work isn’t appropriate. There’s a number of things that one could do. Firstly, there’s a kind of mix of human factors in clinical work that could be done. You can actually evaluate human factors work in clinically disposed patients, so that’s one kind of half we have. The clinical study work itself we hadn’t contemplated and so I don’t think it would be appropriate to talk about how long it will take to do that work. Certainly given the rate at which we had dropped tablets, which is 15 tablets in 30,000, clinically proving that they reduce that rate would be not an insignificant amount of work if it was at all possible. So that’s something which we would need to evaluate, but its not part of our evaluation at this stage.

Okay, thank you.

Pleasure.

The next question is from Oren Livnat with JMP Securities.

Thanks Rich. So you just paved me up for my question with that extremely low 0.5% tablet misplacement rate and I think it was less than 1% of patients that that happened in. Given that those rates are extremely low, can you just help us understand, is the FDA asking you to show some reduction in the actual rate based on the updated interface and instructions or is the point just to show that people understand that that can happen and what to do if it does?

Yes, it still has to. Again, I’ll refer back to the CRL. The FDA is very specific. They talk about mitigations to the inadvertent dispensing of tablets and the appropriate test vehicle, which we agree with the human factors to evaluate that. So your talking about mitigations to reduce it as far as you can and then also what to do in the event that it does occur and we all acknowledge that if your asking individuals to take something from A to B, there’s always a possibility of a mis-step between A and B and so to instruct both patient and healthcare provider as to what to do in the event that something goes wrong between picking up the device and then putting it on your time to dispense the tablet. So its very much the latter, but the mitigations that we have proposed would be appropriate as the agency suggests to test the human factor study.

Well, just to follow-up again. So obviously the second part of that, what to do if it does occur, I get it. But again, since we are talking about small numbers of people and very rare occurrences, presumably there’s not going to be any data you can point to, to show that you’ve in fact mitigated their actual occurrence, because the rate is going to be so low. So is it just intuitive like asking a patient a question. ‘Do you understand that you need to be aware of this?’ so that implies that they would be less likely to make that error, do you know what I mean.

The human factor doesn’t quite work that way. What the human factor does, you give a patient or a healthcare provider an instruction and you evaluate their ability to follow their instructions, in the basis sense that if they can follow the instruction, then you can mitigate whatever it is that you are trying to assets. I’ll give you a concrete example. With Zalviso we have a thumbtack, which the patient wears on their thumb. It has to be close to the dose button to get a dose, correct. So if the patient picks up the device with the hand that has a thumbtack on it, there’s a risk that they could press the dose button somewhere between picking up the device and putting it in their mouth. If you instruct the patient to pick it up not with the hand with thumbtack, but with the other hand and they can follow that instruction repeatedly, there is no way that you can actually does a tablet until you bring the thumb with the dose – with the thumbtack up to the dose button to press it, which presumably you can instruct them to make sure its in their mouth or forehand. That’s part of what we have already submitted to the agency as one of the mitigations to demonstrate the mitigations against the inadvertent dispensing of tablets, that’s part of, one of the elements that they haven’t reviewed yet. And so we’ve done a number of mitigations already and presumably those are to the agency against this particular issue. And what we are doing now and what we are proposing to evaluate is continuous of that particular that relates to what do in the event of a dropped tablet for either the patient or the nurse.

I hate to just harp on this, but again since these rates are so low, yes you can see that someone used the other hand and what percentage did that. But obviously the rate was so low and if you look at guidance for device human factor studies, obviously its nothing that’s setting stone with the FDA. But they do talk about acceptably low error rates when it comes to devices, and I would think that a 0.05% error rate that you saw on clinical trails would not alarm anybody and especially in the setting of a – in the healthcare setting, not at home. So I’m just wondering if there is any chance that you can’t show statistically or hard data proving clinical mitigation. Is there any reason to think that they can say well, you did it, you improved your instructions, you at least addressed the issue, but the rate is still low anyway, that’s not a deal breaker for us.

Difficult to comment, because again the registry body has obviously requested that we look at this issue and that we put in as many mitigations as we can to what is already as you rightly discussed, and then if it had a low rate of occurrence. We’ve done that partly in the material that’s been submitted. We continue to do that. I think the call here and it’s the responsibility of the sponsor to put in as many mitigations as possible to reduce that error rate down to as low as passable. Again, I don’t think anybody’s expectation is to get to a zero rate or to get to no dropped tables, humans are humans, and we’ll continue to move forward to evaluate the mitigations that we are describing to the agency, and that will part of the protocol that we present to the agency for them to review and comment on.

All right, thanks Rich and thanks for everything.

Thanks Oren.

This concludes our question-and-answer session. I would like to turn the conference back over to Richard King for any closing remarks.

Thanks Chad. I’d just like to thank Tim and Adrian for joining the conference call today, and obviously also to thank everyone for your time and questions on this call and even on previous calls as we kind of move forward. Just one other comment, I think David Amsellem referred to beating a dead horse. I don’t like to be told the dead horse, but that’s a time and place for another discussion later on. Anyway, with that thought, I’ll leave you and have a good rest of the day.

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.