Thank you, Matt. Good morning. During this third quarter, we have focused our strength of the progression of the NDA, interactions with potential partners, preparation for commercialization and the initiation of the Oncology 1106 Phase 2 Trial. Recording the NDA resubmission, we understand that the FDA is currently reviewing our submission and as of this moment, we have not received any feedback that would indicate a concern with our resubmission or the PDUFA date. We will certainly continue to work with the FDA in collaborative manner going forward. Also, we get ask from time to time about the minutes on the end of the review meeting held last June. Around this standing is that the FDA is focused on our resubmission of the NDA, so the minutes may have taken a lower priority. With the recent CRLs to Amylin, ALKS and Arena that seems to be concerning the industry that FDA actions are becoming less predictable. But the CRL to Amylin regarding Bydureon was specific to a requirement both the FDA’s guidelines for a QT study, apparently Amylin did not perform the specific test and that led to the CRL. We do not anticipate any such issue for AFREZZA because we did conduct the QT study following an in-depth discussion with the FDA on the study protocol. Nevertheless, the uneven industry can certainly affect our biggest transaction. We believe that it’s prudent for us to be patient in our partnership discussion because deal negotiations will probably be more productive and deal terms more favorable once AFREZZA is approved or at least when the label is finalized. We are therefore continuing our interactions with potential strategic marketing partners with the aim of aligning deal negotiations with the PDUFA dates. And as you can appreciate, we are rapidly approaching our PDUFA date, so it would in any case be difficult to finalize the transaction before PDUFA. We recently received a first of several packaging machines at our manufacturing facility in Danbury. It’s exciting to see the [inaudible] of AFREZZA technology becoming a commercially bio [ph] product opportunity and to see the Danbury facility progressing towards full scale manufacturing. The early scale processing very successful and the readiness activity is continuing. In our continued efforts to further differentiate AFREZZA from other diabetes therapy, we have planned a few new trials. But I will hand the call over to Dr. Peter Richardson to address some of this initiative and the start over with our Phase 2 Oncology Trial. Peter?

Thank you, Hakan, and good morning. In today’s call, I’d like to update you on the progress in three areas over the past quarter. The ongoing FDA review of our Class 2 resubmission for AFREZZA, the next steps for our 3B4 Program and start of our Phase 2 Program with MKC1106. Our interactions to the agency have been routine up to this point and indications that the review is progressing normally. We’re still a couple of months away from the PDUFA dates and at this stage would not anticipate significant discussion of the potential label. As in the consistent feedback in the reviewing division, we’ve not had any indication that there would be any plans from an advisory committee for AFREZZA. The focus seems to be getting on with the review of the data set that we had presented to address the points for the Complete Response Letter as indicated by the exceptions of our resubmission we review early in July. We do not anticipate giving further updates or commentary on the progress of the review of commenting on the FDA interaction until we receive either a definitive action from FDA or a change in the timing of their response. In the meanwhile, we started preparation of our plan Phase 3B4 Program and aim to support the launch of AFREZZA with additional data from studies conducted within the anticipated label. These studies are intended to further demonstrate the significant benefits of AFREZZA. We intend to prepare these studies and conduct them in two phases. The first phase will be a small pilot study followed by a large expansion later. The first trial to start will be Affinity 2, study comparing meal time AFREZZA head to head with meal time Humalog in patients with Type 2 Diabetes requiring insulin intensification. We…

Thank you, Peter. As Hakan and Peter have said, the FDA review of the amended present NDA is proceeding towards the December 29 PDUFA. Let me repeat that although we cannot predict actions by the agency, we have received nothing that so far would suggest any issue that might derail or delay accrual of AFREZZA beyond the scheduled action date. We are continuing to work collaboratively with the agency to support their review of our resubmission. Even before approval and our partnership, it’s important that we begin planning for commercialization of the AFREZZA system. MannKind must therefore increase that focus and begin to plan for the launch. Our goal is to secure global partnership with a major company and such discussions with a number of potential partners are moving forward. However, as Hakan noted, we do not expect to reach closure until after the label is finalized. That said, we cannot comment further on the partnership until it’s appropriate to announce the definitive agreement. In the meantime, we are preparing for commercial readiness. The first of the new commercial filling and packaging machines that will be used with the AFREZZA installation system was delivered to our Danbury, Connecticut factory in August. We are in the process of qualifying that equipment, which has been in development for over a year. This new system is something to behold. It is fully automated and truly amazing. This is huge, about 85 feet long. The input is Technosphere insulin powder, dose cups, cartridge covers and the packaging materials. The output is finished boxes of 90 cartridges that should be suitable for one month of therapy for most patients. The automation includes inspection and weighing of each cartridge and any cartridges bailing inspection are replaced by the robot. This system produces cartridges at the rate…

Thank you. (Operator Instructions) Our first question comes from Simos Simeonidis. Your line is open, and please state your company name, sir. Simos Simeonidis – Rodman & Renshaw, LLC: It’s Simos from Rodman & Renshaw. Thanks for taking the question. Hakan, you preface some of your remarks when you reference the Amylin Bydureon situation. And you said, basically, this doesn’t concern us really because they hadn’t done the QTC study and we have. But I was going to ask you, I think the bigger issue is not whether you’ve done the specific study, which you obviously have and you have the data. But would you be concern that the agency could respond to your response to the first CRL with another CRL that brings up new issues that were not discuss in the first one, which was basically what happened to Amylin.

Well, as I said, also in my comment, there seems to be a concern of – the some of the unpredictability or [inaudible] actions right now in the industry. So, I mean certainly cannot seem absolutely confident that that will not happen. They only thing I can say as of this point in time, we certainly have no indications in our interactions with FDA that any new issues based on the additional requirements, additional information or compliment the information have been requested of us. So, certainly, I will feel a lot more comfortable after the PDUFA date, after nothing has come forward. But at this point in time, Simos, I have no indication of any further requirements on the FDA. Simos Simeonidis – Rodman & Renshaw, LLC: Okay. And then, if you can comment on where the label discussions and the REMS program discussions are right now.

Peter?

Yes. As I indicated, we’ve not stage and review of anticipated label discussion. The REMS discussion and the things that happened before the initial CRL are standing and our REMS plan has been submitted and I anticipate the discussion of that at the end of the cycle. As Hakan was indicating, what we’re dealing with at the moment is the usual technical questions and interest of the agency and the aspects of that and we’re clearly going to have been normal post-asset review, which I think is the way that the agents will be looking at this as they set foot at the appropriate way of managing it from the agency’s point of view. Simos Simeonidis – Rodman & Renshaw, LLC: Okay. And as final question, you mentioned 60 days left until PDUFA. It’s probably likely that we’re not going to see a partnership before then, if you were to get approve at the end of December, would you have to – would you wait for a partnership to be completed or would you try to take advantage of the two or three months until the partnership happens and launch on your own? What are your thoughts on that?

Well, let me say that we are not filing the launch at the beginning of the year. Our plans – we’ve always said that we couldn’t launch before the second half of next year. We want to have three machines fully installed, validated and ready to go before we actually launch, that’s our plan. So, it really is insignificant whether we complete the partnership in December or early in the year. Simos Simeonidis – Rodman & Renshaw, LLC: Okay, thank you.

Our next question today comes from Keith Markey. Your line is open, and please state your company name, sir. Keith Markey – Griffin Securities: Good morning. This is Keith Markey with Griffin Securities. Thank you for taking my call. I had a couple of questions about the reference to an echocardiogram that would be required or you thought might be useful for filing with the European Union and I was wondering if you could tell us a little bit about that and whether that data would be useful for submitting to the FDA at some point.

Yes, Keith. The echo data has been something that the agency had request, the EMA had requested in one of the discussions that we had with them and we believe it would be very useful to have those data at the time that we make the filing in Europe, which we’ve not them. I think as we are – as the timing here has progressed, we’re looking at being able to put a substantial data set with the new device into a submission in Europe and so generating some echo data is the subset of patients in these studies is a very appropriate thing to do. Obviously, longer term echo data from the European point of view can be submitted later in the review cycle. So, now that’s our plan at the moment and I think it makes absolute sense to take that opportunity of doing that in these 3B4 studies. Keith Markey – Griffin Securities: So, we should expect the echo data to be completed after you’ve actually already partnered?

Yes, in the longer term. I think we’re doing this really just to enable us to thought about filing first as in Europe and how long going echo data is available. Keith Markey – Griffin Securities: Okay, great. Thanks. And then one other question, when might you provide interim data from the open label melanoma study?

Clearly, if we – at completion of 19 patients, we’ll be having a formal, like this is an adoptive two-stage design. So, we will be announcing whether we move forward with the study and at the additional 25 patients if it looks appropriate thing to do that time. So, clearly, in this patient population, we’re looking at recruiting fairly slowly and so we’re anticipating that we should have complete that first half of next year. Keith Markey – Griffin Securities: Great, thank you very much.

Our next question comes from Steve Byrne. Your line is open, and please state your company name. Steve Byrne – Bank of America Merrill Lynch: Hi, Bank of America Merrill. Peter, can you talk a little bit more about that QTC study. Can you talk about the level of renal impairment that existed in subsets of the patients that you treated in that study, what were the dosing compared to the AFREZZA dose in the new dreamboat device.

Yes, yes. Good questions in terms of QTC studies. It seems that everyone is trying to become an expert on this rapidly. We had the benefit of quite an explicit interaction with the agency around this in terms of, obviously is a well recognition [ph] to the absolute ingredient in our product. Insulin is well-known and characterize and QTC would not normally be a requirement there. So, we were conducting a QTC study specifically to look at the novel incipience [ph] in our product, which is biologically inert FDKPs, so you’d have no a priory anticipation of any impact on QT changes on something that has absolute no effect in any preclinical system or any potential design with any receptor that’s known. So, we had originally approach this from discussion with the agency that the QTC study would not be required. But the agency was very clear in terms of this is now a standard in new drug application and we interacted over the design of this study at length and there was a review of the protocol. The protocol has been conducted absolutely according to the guidance, which has been in the industry now for a while looking at that with a positive control of a drug that does affect QT interval. And we studied decent doses of FDKP, the exposure there would be up to eight Foley [ph] single cartridge below dose cartridge or four filled high dose cartridge that would be used with patients. And that margin again is something that was discuss with the agency and how we should approach that. The results, actually we have summarized on our website, so you can go there. But just to say that there is no indication of a QT issue with the product. Steve Byrne – Bank of America Merrill Lynch: And Peter, does the FDKP accumulate …

I think. Steve Byrne – Bank of America Merrill Lynch: In patients that are renally impaired?

Yes. Well, we’ve actually well characterized this in terms of mild and moderate there’s no risk of accumulation. The attributes of accumulation of renal impairment is to insulin. Insulin is something where you – all careful interns as the handling of insulin patients with severe renal impairments, that’s well done. But in terms of potential for FDKP, no. there’s no potential for accumulation in mild to moderate. And severe renal impairment, when patients have renal failure – yes, there would be, but that wouldn’t be sensing that you’ve put into a QT study. Steve Byrne – Bank of America Merrill Lynch: And I thought you – one of the other studies that you were planning Peter was a repeat of 117 using the dreamboat device, is that also in plans?

Not a repeat in 117. I think what we’re doing is building all the learning from 117s that we’ve talked about the two studies the Affinity 1 and Affinity P. The one that’s most comparable to 117 is Affinity 1, which is in a similar group of patients, but perhaps are taking those that are really trying to get closer to a more aggressive target of less than 6.5. Remember in 117, what we saw that we got twice as many patients at those low levels able to get to 6.5 and below without hypoglycemia. And we really want to focus in on that group of patients in Affinity 1, using a modified algorithm as well in patients to adjust dosing in compared to the actual blood glucose measured level. One of the things that the kinetics allowed us to do is be able to reach very rapidly to a change and we’re piloting that and looking at how that works in this Type 1 patients based on our learning from 117 that’s how we can get even further improvement from that. Steve Byrne – Bank of America Merrill Lynch: And just lastly, you’re with a new filling machine, are you guys starting to build inventory?

Not really just yet. First of all, the machines are just going through qualification now and they have to be validated, so then we’ll be of course doing preproduction lots in the validation program. But we’re not yet embarked on inventory build. But we will be making powder in the not too distant future. Steve Byrne – Bank of America Merrill Lynch: Okay, thank you.

Our next question comes from Jon Lecroy. Your line is open, and please state your company name, sir. Jon Lecroy – Hapoalim Securities: It’s Hapoalim. Thanks for taking my call. I just had a question on Affinity 2. How does that differ from – I think it was the 014 study, which was in Type 2 diabetics other than the echo’s?

I will probably quote a small end of Phase 2, beginning Phase 3 study. So there we’re looking – if I were looking here in terms of combination with Lantus and we’ve got a depth and algorithm in terms of that. So, I think it’s got differences in terms of the 014 study and that which we have. Jon Lecroy – Hapoalim Securities: Okay. And then I think in the past, you guys have said how many partners were still in the running. Do you have any comment on what you’ve narrowed it down to?

No comment at this point, until we have definitive to announce. Jon Lecroy – Hapoalim Securities: Okay. And then have all the pre-approval inspections for the plans in the U.S., international is all that finished at this point with the FDA?

Well, all of that was completed. Except that, of course, now we have this new machine, which they may or may not want to evaluate. Jon Lecroy – Hapoalim Securities: Okay. And then would the tracker go to the FDA, let’s say the approval process extends beyond the third quarter and the Seaside deal may not be in effect at that point. What are you financing plans beyond the third quarter?

We haven’t announced financing plans and it’s probably imprudent to do so that far out. Obviously, we anticipate that are [inaudible] you’re stating here. Jon Lecroy – Hapoalim Securities: Okay. Thanks.

Our next question comes from Doug Dieter. Your line is open, and please state your company name. Mr. Dieter, please check your mute feature. We’re unable to hear you. Sorry, we are not – Anthony Espiduda – Imperial Capital: Hello?

Yes, sir. You may go ahead. Anthony Espiduda – Imperial Capital: Hi, this is actually Anthony Espiduda [ph] at Imperial Capital. In terms of the AFREZZA [ph] you can expect, is there any guidance that you can give us or some indication of what kind of historical licensing agreements you’re looking at to arrive at your own expectations?

I think it would be unwise to speculate as to what those agreements might look like. I mean we can all go find examples. We don’t really think necessarily they apply. This is a very unique product with a very unique opportunity. So, let’s wait and see when we have something to [inaudible], obviously we will. Anthony Espiduda – Imperial Capital: Okay, good. Thank you.

Our final question today comes from Leah Hartman. Your line is open, and please state your company name. Leah Hartman – CRT Capital Group: Good morning, gentlemen. It’s Leah Hartman with CRT Capital Group. I did have questions on QT study, but they had been answered. So, thank you very much, Peter, for the detail on the escalated dosing relative to what we expect to be the prescription for patients. I was wondering if someone could speak to the timing of running the planned validation on when you expect that might get concluded with approval by the FDA on the plans, please.

Peter, do you want to answer that?

Yes. Knowing that we’ve not gotten an indication that the agency will do a further approval inspection, the one they conducted was very comprehensive and we were very pleased with that result. They may comeback, but there’s no indication of that and I think that it would really be as we move into the qualification. As Al said, the normal process here is to look at that when you produce commercial batches to ensure that you have met that and that will be done in discussion with the agency as would be normal. Leah Hartman – CRT Capital Group: Okay, great. So, it looks at the moment that there’s not been, nothing arise with respect to the actual manufacturing in the package here.

Absolutely … Leah Hartman – CRT Capital Group: Yes.

One of our jobs is to make sure we’re ready for the agency and they, of course, can come without announcement anytime and being prepared for that is something that we ensure we are. Leah Hartman – CRT Capital Group: And do you have an update for us with respect to the EMA filing. I mean I think a long time ago you suggested would probably be six months post-approval in the U.S. But it sounds like you have a package coming together.

Yes, there’s certainly a package coming together. The original NDA forms the great basis of that. I think we’ve taken the opportunity in terms of in Europe as an additional stability requirement with new product, with the device and to be able to submit with additional data on that device will be helpful. And of course, we’re really looking for making a submission with a partner, if they’re appropriately able to do that. So, the two are somewhat about tied, although we could make a submission and we want to do that with the best possible approach that we can take. Leah Hartman – CRT Capital Group: And my final question is on the financial side. So, Matt, for you. It appears to me that you have not yet tapped into that equity line of credit.

No, actually we have. Leah Hartman – CRT Capital Group: Okay.

We’ve done one sale so far. We don’t … Leah Hartman – CRT Capital Group: Could you could start that on September 22, is that the first date?

That was the first potential date, it did not occur on that date. Leah Hartman – CRT Capital Group: Okay.

If you remember, we establish the $6.50 floor? Leah Hartman – CRT Capital Group: Yes.

And we weren’t above it at that time. It’s slowly based on the volume weighted average price. We weren’t – so, we’ve only had one sale up to this point. That will be in our Q that I think was getting filed sometime today with something else [ph] … Leah Hartman – CRT Capital Group: Okay.

We don’t typically announce each sale at it occurs, it’s not required because all the parameters are out there in public. So, people can readily determine whether they occur or not. You just see them in the Q, although I’ll give you a clue. Since Al’s conversion of his note is closely linked to that deal and he does have to file that very quickly every time it happens, that will be a good clue that it has probably occurred. Leah Hartman – CRT Capital Group: Okay, all right.

Sure. Leah Hartman – CRT Capital Group: And I did catch that hint in the press release that his parallel transaction was being executed, I just didn’t have the details of the timing. So, thank you very much.

Pleasure, thank you.

That does conclude the Q&A portion of today’s call.

Thank you very much for joining us and we look forward to seeing you certainly in the next quarterly call and perhaps sooner. So, have a good day.

That does conclude today’s presentation. Thank you all for joining. You may disconnect at this time.

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