Greetings and welcome to the Prosensa Third Quarter 2014 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ms.

Celia Economides, Senior Director of Investor Relations and Corporate Communications. Thank you. You may begin..

Thank you, operator, and thank you everyone for joining us. On behalf of Prosensa, I would like to welcome everyone to our third quarter 2014 earnings call for the quarter ending on September 30, 2014. With me today are Hans Schikan, Chief Executive Officer; Giles Campion, Chief Medical Officer; and Berndt Modig, Chief Financial Officer.

Earlier today, we issued a press release containing the results for the third quarter of 2014, which is available on our website at prosensa.com. Today, we also filed our quarterly financial statements and management discussion and analysis with the Securities & Exchange Commission.

During today's call, we may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements about our future expectation, clinical developments and regulatory timeline, the potential success of our product candidates and financial projections.

Actual results may differ materially from those indicated by these statements. Forward-looking statements during this call include statements around our exon-skipping drug pipeline including drisapersen, the regulatory review of our product candidate, our intellectual property position and our financial position.

Such forward-looking information involves risks and uncertainties that could significantly affect expected results. These risks and uncertainties are discussed in the company's SEC filings including, but not limited to, the company's annual report on Form 20-F.

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change.

With that, let me pass the call over to Hans..

Thank you, Celia, and good morning, good afternoon, everyone. Thank you for joining us today for our third quarter 2014 earnings call. On today’s call we will be providing you updates on the status of our lead exon-skipping program drisapersen, the rest of our DMD portfolio and our financials.

This last quarter has been an exciting one for the company as we have made substantial progress in advancing drisapersen for the treatment of Duchenne muscular dystrophy.

To put our achievements of the quarter into context, you will recall that on January 12 we regained the rights to drisapersen from GlaxoSmithKline and thanks to tremendous hard work and dedication by many people in the company we have transferred from GSK numerous data, reports, files and the like of the drisapersen program.

This was a complex process, which included the transfer and assessment of more than 350,000 clinical trial files involving a number of disciplines across the company. We've always been positive about the potential of drisapersen and we continue to be encouraged by the totality of the data from the drisapersen clinical program.

Our pioneering work in DMD for more than a decade means that we have the largest clinical dataset in DMD comprising three placebo controls and two long-term open label studies, treating over 300 patients and comprising over 450 patient treatment years. It has been an amazing journey.

We have learned a tremendous amount that enables us to better understand both the natural history of DMD as well as through the vast dataset we have into context. We have shared our interpretation of the data with key experts in DMD, with patient organizations and with regulators, including additional detailed analyses we have been able to perform.

At the time we received rights to drisapersen back from GSK, we immediately took steps to develop re-dosing plans for boys who had previously participated in drisapersen clinical trials in addition to engaging with regulators in both the United States and Europe.

In September, we commenced re-dosing programs for drisapersen in the United States and Belgium and more recently in Sweden. We've had ongoing dialog with both the FDA and EMA since January to discuss our vast datasets.

This dialog included the discussion on the positive outcome of the first placebo controlled study with drisapersen, which showed statistically significant and clinical relevant results, the second placebo-controlled study which was supportive, and two, supportive open label studies.

The dialogue also focused on the unanticipated negative results of the Phase III study. The emerging hypothesis on the basis of our assessments of the totality of the data is that due to probability [ph] and heterogeneity amongst all the factors that the Phase III trial may have failed the drug rather than the drug failing in the trial.

Based on our analysis we believe that early intervention in this disease may delay progression of DMD and hopefully improve the quality of life and life expectancy of boys with DMD.

We continue to believe that this reliability due to the number of clinical trials sites across the globe, with differences in standards of care and the heterogeneity of the patient population which was more advanced than the disease in our previous placebo controlled studies were key factors leading to the outcome of the Phase III trial.

In the FDA’s written guidance to Prosensa, which we published in full on our website they find that its eligible [ph] but at this stage look like its only conclusive but some of these factors might have contributed to the findings in the Phase III study.

In contrast to the positive and supportive findings in our other Prosensa controlled studies which focussed on more homogenous and less progress patient population.

On June 3, we announced that following the guidance we received from the FDA; we will pursue a new drug application filing for drisapersen, based upon existing data under an accelerated approval pathway. On the 10th of October, just four months later we submitted the first module of a rolling NDA which comprised over 15,000 pages.

Drisapersen has both "Fast Track status" and "Breakthrough Therapy designation" making it eligible for a rolling NDA review. While the official clock will start ticking the moment, the final module is submitted, the FDA have the opportunity to review each section as it is submitted.

An NDA submission is an enormous undertaking and the entire company has been working day and night to ensure a high quality and timely submission. We have engaged a number of reputable and experienced regulatory consultants to assist us in this important process. We plan to submit the second module of the rolling NDA in the coming weeks.

And we will submit the final module once our pre NDA meeting has taken place which is scheduled for the back half of January. Since receiving our guidance letter from the FDA in June, we have several interactions with the agency and continue to be satisfied with the content and consistency of the feedback we have received.

Our most recent face to face meeting with the FDA was in September where we’ve discussed CMC and one in October 22nd to discuss the proposed designs of our confirmatory studies.

In line with the FDA guidance, and our own strategic plans we will be commencing two confirmatory post-approval studies for drisapersen, one of which will be an open label study where the results will be compared with the natural history group of boys.

Secondly, we intend to start a placebo-controlled study with PRO044 in the second quarter of 2015 to further validate our exon skipping technology platform. The protocols are currently being finalized and we will be submitting these in due course to development IRBs.

Details on a number of patients, length of study duration, endpoints etcetera will be shared with the community at the right moment in time. Our dialogue with regulators in Europe also continues.

And based upon number of interactions, we anticipate filing and marketing authorisation application for a conditional approval of drisapersen in the EU shortly after we submit the NDA to the FDA.

Given the urgent need to find effective therapies for boys with these devastating and fatal disease we are encouraged with a favourable outcome of our interactions with the FDA, and with a degree of urgency both regulatory authorities have placed while accelerating these element and potential approval of treatment options.

We are happy for the patient community for the disease modifying therapy is now approved in Europe. PTC's Translarna, which targets a different set of population of voice with DMD than in our exons skipping pipeline. It's a monumental time for all stakeholders in this space and we are honoured to be the key player in this story.

It's clear that patients, families, clinicians, and patients efficacy group voices have been heard loud and clear and for the first time we are in an environment where there is very real hope and where patients and their families have options than before they had no.

We are incredibly grateful to many patients’ advocacy groups that have supported us over the years especially in the last year during some difficult times. We continue to expand our internal capabilities and global presence to meet the needs of a pre-commercial company with experienced employees in both the U.S. and the U.K.

in addition to the Netherlands. With that overview of the encouraging position we are in, I would now like to turn the call over to Giles Campion, our Chief Medical Officer, who will provide some more detail on our clinical development progress during the quarter..

Thank you, Hans. We continue to focus our research and development efforts on our fixed pipeline candidates for DMD with much of attention concentrated on the regulatory submissions for drisapersen. Additionally, we are providing renewed access to drisapersen for previously treated patients.

As Hans mentioned, the first patients were re-dosed in September in the United States and Belgium, and now more recently in Sweden. At this time we are pleased to announce that 15 patients have now been re-dosed with drisapersen, 8 in Europe and 7 in the United States.

9 additional patients have been screened with 5 soon to follow at this time in the two open sites in the U.S. And additional two sites in the U.S. are scheduled to open imminently. We are well aware of the burden that clinical trials can place on hand and rest for this protocol we have made efforts to alleviate burden and to facilitate participation.

We are in to enable home dosing feasible and cost free transport with straight forward logistics and clinical centres through collaborations with qualified service providers. For the remaining sites in North America, protocols have been sent to relevant institutional review boards and are waiting approval.

The submission to help Canada in preparation and we expect to have the first Canadian site initiated before year-end. Our intent is to provide continued treatment for all boys who have previously treated with drisapersen who wish to reinitiate dosing.

It is a time consuming process to set up as each country has affected some often complex procedure plus re-dosing plans and the rest of the world are taking a staged approach.

As announced on our last earnings call, we completed the enrolment of our perspective natural history study designed to further increase the understanding of DMD patients and measure disease progression.

The study has enrolled a total of 269 boys with confirmed DMD between the ages of 3 and 18 from 10 countries across 16 centers in North and South America and Europe. 80% of patients are ambulatory and 20% are non-ambulatory.

The purpose of the study is to characterize the natural history and progression of DMD, which will help inform the design of future studies, to capture biomarkers of safety and disease progression, and to provide comparative data for patients with rare exon deletions/mutations for which placebo controlled trials are not feasible.

Our investment in this study is important and will now be able to serve as a control for the confirmatory program for drisapersen. Interim one year data for this Natural History Study are expected to be shared in the coming months.

In other clinical advances for Prosensa PRO044, our next most advanced product candidates before we have in the clinic addresses a separate subpopulation of up to 6% of DMD patients. PRO044 has completed a Phase I/II study in Europe and results were presented in October 2013. PRO044 is currently on clinical hold in the U.S.

and we expect to submit data to the FDA with the object of having this clinical hold listed. We expect to begin an extension study for PRO044 in early 2015 in addition to a placebo controlled study for this compound in the second quarter of 2015 which may serve as a second confirmatory study for the drisapersen clinical program.

Those finding studies are ongoing for both PRO045 and PRO053 and we anticipate communicating around next steps and results for these programs in the coming months. Our pipeline remains robust and extensive pipeline of any company working in DMD also includes PRO052 and PRO055 which are in advanced preclinical development.

During the quarter, we had continued to progress on noble program PROSPECT, which includes a new and innovative application of our RNA modulation technology platform. The program is moving into preclinical development with preclinical safety service scheduled to commence next year. This approach applies to multiple exon skipping.

Our initial efforts on PROSPECT have been focused on the much rarer disease exons in the 10 to 30 region of the dystrophin gene which could collectively be applicable for up to 13% of all DMD patients.

However as reported in the post at the World Muscle Society, several multiple exon skipping products reached beyond this rare deletion region in the gene which extends the applicability to more frequently patients thus encompassing the 10 to 40 regions.

MDX mouse [ph] studies have been initiated to obtaining proof-of-concept, a single antisense oligonucleotides inducing multiple exon skipping in the 10 to 40 region could address up to 20% of all DMD patients.

We continue to work diligently to pioneer research and development in neuromuscular space and have showcased our tireless efforts from Prosensa to find different collaborators in recent peer review publications and into all presentations during the 19 Annual World Muscle Society Congress, which took place in Berlin in October.

In September, the full data from an exploratory, double-blind, placebo-controlled Phase II study (DEMAND II) of drisapersen in patients with DMD were published in The Lancet Neurology.

The publication of the results of the study, which investigated the efficacy and safety of drisapersen over 48 weeks, confirms the positive outcome of this study, which met its primary endpoint, with no reported major safety concerns. Top-line study results were first presented in April 2013.

In past, based upon this data set, drisapersen was granted breakthrough therapy designation in June 2103 from the FDA. Publication of this key paper on drisapersen in one of the most esteemed peer-reviewed scientific journals in our field with a great endorsement to the robustness of the DEMAND II study and the clinical significance of the results.

After a comprehensive review process by the Worlds leading experts in dystrophin assessment in methodology, we also published the results of our research into developing an accurate and reproducable method for the measurement of dystrophin in patients with DMD and Becker’s muscular dystrophy. We are on online peer-reviewed journal PLOS ONE.

The publication, by Chantal Beekman et al from Prosensa, describes our semi-automated image analysis method, which was shown to be objective that is operator independent, reproducible in multiple samples and experiments and sensitive for assessing dystrophin levels by immunofluorescence in muscle biopsies from BMD and DMD patients in natural history studies or clinical studies with compounds aiming to restore dystrophin expression.

Lastly, at the World Muscle Society in Berlin, together with our collaborators, we presented 12 abstracts that highlight the rigorous work conducted by our scientists and collaborators, including biomarkers to measure disease progression, such as MRI, Digital droplet RT-PCR, clinical results and our preclinical work on multi exon skipping, which could address the rarer mutations in those regions 10-40 in the dystrophin gene.

We are pleased with the recognition our research and developments have garnered and refined to the community in recent months. Thank you. And with that, I will pass the call over to Berndt Modig, our Chief Financial Officer to provide you with an update on the financials..

Thank you, Giles. On the financial front the condensed consolidated financial statements of Prosensa have been prepared in accordance with IFRS as issued by the International Accounting Standards Board, IASB. The consolidated financial statements are presented in Euros which is the company's functional and presentation currency.

All amounts mentioned are in Euros unless otherwise specified. Prosensa's cash and cash equivalent as of September 30, 2014, were €62 million, compared to €69.5 million as of June 30, 2014, and €82.2 million as of December 31, 2013. The decrease in cash and cash equivalent was mainly due to operating activities.

Revenue for the three months ended September 30, 2014, was nil, compared with €2.4 million for the same period in 2013, due to a decrease in license revenue of €1.3 million, and a decrease in collaboration revenue of €1.1 million due to the termination of the research and collaboration agreement with GSK.

Research and development expense increased from €4.9 million in the three months ended September 30, 2014, to €8.4 million in the three months ended September 30, 2014.

Research and development expenses mainly increased due to the expansion of our development and regulatory capabilities, directly impacted by the termination of the research and collaboration agreement with GSK, as well as the costs of preparing a regulatory file for drisapersen and the progressing clinical phase I/II studies of PRO045 and PRO053.

General and administrative expense increased from €1.9 million to €2.4 million in the three months ended September 30, 2013 and 2014, respectively. The increase is primarily due to share-based compensation in costs associated with the regulatory filing in the three months period ended September 30, 2013, compared to the same period in 2013.

On July 3, 2014, we filed a shelf registration statement (Form F-3) that provides the flexibility to raise up to $150 million in a primary offering if we choose to do so.

Net loss for the third quarter 2014 was €10.6 million, or €0.29 basic and diluted loss per share, compared to a net loss of €4.3 million, or €0.12 basic or diluted loss per share, from the third quarter 2013. We expect that cash and cash equivalents as of December 31, 2014, will range from €52 million to €54 million.

This guidance does not count for the impact of any future acquisitions, dispositions, partnerships, licensing transactions or changes to the company’s capital structure including future securities offerings. I will now turn the call back over to Hans for some closing remarks.

Hans?.

Thank you, Berndt, and thanks to everyone for joining the call today. We remain committed to enabling a brighter future for DMD patients and to providing long-term patient access for drisapersen and our extensive follow-on programs.

We are excited that boys have started to be re-dosed for drisapersen and are incredibly pleased that our growing NDA submission is currently underway which we anticipate completing in the first quarter of 2015 with a European filing potentially shortly thereafter.

We look forward to initiating our confirmatory studies for drisapersen early next year and we will continue to work very closely with and strengthen our collaborations with key patient groups. This is a very exhilarating and encouraging time for us. We look forward to updating you as our plans progress.

I would now like to turn the call back to the operator who will open the line for questions..

[Operator Instructions]. Our first question is coming from the line of Yaron Werber with Citigroup. Please proceed with your question..

Hi, this is Kumar in for Yaron. Thank you for taking my question.

So what analysis do you think could be most important for approval, will it be the pooled Phase II and Phase III data or is the younger than seven year old? And have you guys had discussion with FDA and EMA to see whether this will be acceptable for accelerated approval? And also what other analysis do you think the FDA might rally on for accelerated approval and I have a follow up..

Yes, thank you for your question. As you know we’ve had a number of conversations with first the FDA and members of the European Regulatory community and what we have been sharing with them is the totality of the data across the drisapersen program as you know that is three placebo-controlled trials over 300 patients.

And I think what has impressed some has been the totality of the data and also the effect that we’ve seen in the young though more homogenous populations which were involved in the Phase II study and also the data that we have generated from the open label extension studies.

So I think the sense that in terms of our on-going analysis they will be supporting both the robustness of those data sets and those populations, the robustness of prolonged observations and also examining the theory that part of the reason for the Phase III result is related to the fact that there was heterogenative patient population with a different patient population of Phase III, in fact that this was conducted over multiple sites across the world.

So, those were data that we’ve been presenting with them and we are continuing our analysis with this area..

And also you have guided filing in Q1, will it be early or late and what is the gating factor to complete polling NDA in the U.S?.

And this is Hans here Kumar.

It’s a good question indeed, we have recently presented at the Credit Suisse Conference in Phoenix which was also webcast and it’s on our website that our guidance says that we will be able to submit our lost module of the NDA submission in the first quarter of 2015, which will be shortly after an FDA meeting and pre NDA meeting which is planned for the second half of January of 2015 And the most important reason is here that the work which we have been doing on completing this file has been enormous.

There are more than 350,000 clinical trial files and it’s more -- work the numbers, working as I mentioned in my prepared remarks sometimes even day and night to get these documents together, and to compile that file is a major undertaking. And we want to submit of course a file which has the top quality to be approved as well at a certain moment.

So, for that reason we have given guidance last week that we are planning out to submit our file after we have that pre NDA meeting in January which will begin in the first quarter.

And I want to stress here as well that this is not related to the FDA in our view trying to [indiscernible] had a meeting originally, tentatively planned for the end of the year that could – that not take place and then we have two alternatives, one which was earlier and one which was later and we gladly accepted the later date in view of the efforts we were undertaking in order to get the file completed.

So that’s our look at the guidance, first quarter of 2015 and it will be – shortly thereafter the distribution done in this year as well..

Thank you. Congratulations on all the progress..

Thank you. Our next question is coming from the line of Joseph Schwartz with Leerink Partners. Please proceed with your questions..

Great. Thanks very much. And let me also add my congrats on all the progress.

I was wondering if you could give us some insight into what constitutes the first, second and third modules of your NDA?.

Hi, Joe, this is Hans Schikan. Yeah, also a great question. The first module which went out comprised over 15,000 pages and was related to preclinical work.

The second module which will go out the next few weeks will be the CMC module and as you can imagine the last module which is the clinical module and the finalizing document is relevant that having more than 350,000 clinical trial sites is the most efforts one, the one which takes most efforts.

So the first one being preclinical, second one seems to be platform both in clinical around that place. And we had a meeting with the FDA in September to discuss CMC.

We had a meeting on the 22nd of October to discuss our confirmatory trial designs, and right now we are in the process apart from building that site [ph], also finalizing the protocols of those confirmatory studies, which are anticipated to start in the first half of 2015.

As you know, two confirmatory studies that drives person open label study to start expectedly in the first quarter and PRO44 placebo-controlled study to start in the second quarter..

Okay. That’s helpful. Thanks. And then also I was curious if given the FDA’s express in reservations after some – after visit to competitor’s site that collected and analyzed immunohistochemistry data.

I was wondering if you could tell us anything as far as with the FDA has seen first hand at your now at that sites where you collected and analyzed biopsy histology data.

If the FDAs been there – if you’ve detected any similar reservations or not?.

Yeah. Thank you for the question. I think the first point to make is that our file is dependant on a clinical endpoint.

So, as you know, in all of the placebo-controlled study and the open label studies we have submitted clinical data on only validated clinical endpoint which is the six minute walk on – that’s the basis on which the efficacy per drug will be judged.

As far as drisapersen is concerned, we see this is supportive in terms of demonstrating mechanism of action. And if you remember we recently had our Phase II study publishing Lancet technology went on line is September with Thomas Voit was a leader of [indiscernible] indicated the results of our drisapersen.

In terms of your specific question, we have been in communication with the FDA regarding our methodology, our methodology also recently get published as I indicated in my prepared in Clause 1, so they are aware of the sensitive to our methodology, but – and they actually use our internal lab in percent to do those analysis.

In terms of the FDA visiting our lab that is not something that we’ve discussed with them that I would also point out, but the methodology that we’ve been used has also been – was also part of the publication by Montoni [ph] in Neurology, which went online in October 29, which is showing comparability with the methodology across the number of expert labs in terms of assessing drisapersen methodology.

So while we understand, the FDA has also indicated that methodologists are still really being assessed, we are confident of the amount of time and effort we put into understanding how to assess drisapersen and we think this growth – the going to be robust..

That’s very helpful. Thank you..

Thank you. The next question is coming from the line of Chris Marai with Oppenheimer. Please proceed with your question..

Hi. Good morning guys and thanks for taking the questions.

First just looking about drisapersen and then placebo-controlled trial of PRO044, remind us, are you thinking about including biopsy of this trial? And then secondly, with respect to PRO044 trial, will it be suitable for approval given that will be placebo-controlled and what are your plans probably now? Thanks..

Thanks for your question, Chris. The protocols of these studies though that drives drisapersen open label study and the PRO044 placebo-controlled studies as overall, so it highlights and the [indiscernible] which we received from the FDA on the 2nd of June, they are still under preparation. So, we have not finalized those protocols yet.

And we had in the meeting with the FDA on the 22nd of October based on the feedback, the consistent feedback we received there. We are now finalizing those protocols and the plan will be to submit those protocols to the FDA and later onto the IRBs as well, so that these studies can start in the first half of 2015.

The details around what exactly is being done on those trials, we have not disclosed yet in fact that the discussion is still ongoing internally based on the feedback from the FDA and the preparation are still ongoing as well.

But regarding your question of biopsies, the PRO44 placebo-controlled study was particularly asked for by the FDA in our interpretation of the latter in order to see rather a potential co-relation could be found between the dystrophin expression in that trial and functional outcome, so it would make sense in that trial to then look at biopsies as well..

Thanks.

And then, I guess the prospect to additional endpoints for that trial and your confirmatory trial, are you going to be looking at MRI and then also PK [ph] and will those be exploratory or secondary endpoint?.

We have not disclosed the protocols including the endpoints primary, secondary exploratory yet that flow influx, but you are right about the fact that MRI seem to be very interestingly marker to look at as well. As we have -- society data were release on MRI data.

We’ve also shared with the community preliminary results on MRI data in our studies where you seem to observe that second filtrations less than voice treated with drisapersen in comparison to the placebo patients that’s when it comes to these confirmatory studies, as soon as we have those protocols ready and available we will of course share these with the community, with investigators, with sites and with the patient community as well as at our usual channels.

You want to add anything here, Giles..

We have been interested in the potential energy for some time. You may remember we were recipients of an FP7 European Commission grant to examine the role of imaging with some – together with academic partners and that is something that we have in cooperated into our earlier programs.

And we’ll be looking to be able to make full use of everything we have learnt in the confirmatory programs..

Okay. Great. And with respect to the confirmatory programs, how confident are you that these will be supporting our conditional approval in the year.

And then, also given the burden of even open label trial, that you and EMA likely to require fully rolled trials prior to granting a conditional approval? And then finally could you maybe elaborate on any of your discussions with the regulators in the EU regarding any approval filing? Thanks.

We have interactions both with the FDA and with EMA on drisapersen. Based on those interactions we had with numbers of the regulatory communities in Europe, we feel confident that we can make this statement about submitting our marketing authorization application shortly after our submission of our NDA in the U.S.

and of course it would be the most ideal situation at the same confirmatory program which we are currently applying or will be applying for the U.S. cannot be used for Europe.

Based on the interactions we’re had, we think that there is a possibility reason why we are planning to submit that marketing authorization application shortly after the NDA filing..

Okay. And just because I don’t if I got it, but with respect to PRO044 study, is that going to be suitable for approval for PRO044 given that it sounds like its going to be placebo-controller and that’s my last question? Thanks..

Normally in this [indiscernible] space placebo on larger – well defined placebo-controlled trial could be sufficient for approval.

Of course, that will becomes the outcome of that trial, but our goal would be that that’s confirmatory study which is being setup for the purpose of drisapersen confirmatory program that that also may have the potential to eventually becoming outcome of that study and need approvals for PRO044, but its rather premature to make that right now, because the trial hasn’t really started yet, but that will be our goal at least..

Great. Thanks. Congrats on the quarter..

Thanks..

Thank you. Our next question is coming from the line of Jeremiah Shephard with Credit Suisse. Please proceed with your question..

Good morning. Thank you for taking my questions.

On terms of the FDA panel meeting, what are doing now to prepare for the panel and for potential panel and what profits do you expect them actually to come out during a panel?.

Actually a bit early – too early to start speculating about the panel and the questions we may get there, but you can’t imagine that over the last already many months actually since September 2013 when we had the first outcome, the top line results of the Phase III data we have basically been working every single day on the data in order to first and foremost look at our file, that’s a top priority right.

But essentially FDA has indicated that the Advisory Panel is likely that things will happen. We also already are preparing for a potential advisory panel.

So we are indeed working with consultants in this space to make sure that we are actually prepared for every single question we may get from an advisory panel and that’s a best preparation, but again the number one priority right now is to get our maximum view and the next day OPTIMA view to the FDA and to have a successful filing and submission process..

Okay. And then in terms of EU filing, how long does the EU review process -- the page for these type of rare diseases.

And also do you plan on updating the Street in terms on and in sort of regulatory time points during a review process or do you get questions back and as you respond back to those questions?.

The EU process normally will take longer then in the U.S. if we’re able to submit our file in Europe shortly after the NDA submission in the U.S. than it normally will take more than a year before you actually will get approval.

Now there is a process in Europe which is called accelerated assessment and that is the one we’re looking into, but right now the number one priority is the U.S. shortly thereafter followed by Europe that in every single way we will try to accelerate those guidelines for Europe as well.

We think that the actual submission or the marketing authorization application can happen shortly after the new drug application in the U.S. given the fact that it will be based on the same data, but the format will be different. [indiscernible], but it will take traditionally longer, so you are getting into 2016 in that case.

But we have not provided any concrete time lines as to when we would expect that approval will be granted and that very much depends on number of choices we have make there..

And the last question, in terms of that natural history study that you spoke about previously, have you got it to which meeting you might expect to release that data? And are you planning on releasing that day in service stage manner or could we see the more a totality data it wants?.

Yes. The first 80 patients and we will have data in those first 80 patients in natural history study some of by you and then Giles maybe can initiate that in more detail later.

And after collecting that data and reviewing that data that the most likely dissemination will be on the medical or scientific conference, which will then take place somewhere early next year. Of course the annual meeting of the American Academy of Neurology which takes place from the 18 to the 25 of April in Washington D.C.

It’s a very important forum where many neurologists and lots of specialists will get together, but then that would [indiscernible] of course and that are abstracts will be accepted there as well. But that would be a fair example and not where we could disseminate data on own growing programs..

Okay. Great. Thank you for taking questions..

[Operator Instructions] Our next question is coming of line of Debjit Chattopadhyay with ROTH Capital. Please proceed with your question..

Hey, good morning, guys. Couple of questions. First regarding the FDA meeting at the end of the January, are you comfortable that they will not throw out a new curve ball in terms of getting your pivotal study up and running before they start looking at the NDA.

Number two, a question on drisapersen, any feedback on the FDA regarding seeking biopsy samples from different muscle groups, is that a concern for them or does it have to be from the same muscle not just the same region? I’m just wondering in terms of what happens with scar tissue formation. Thank you so much and congratulations with the others..

On the question to what extent the meeting which is planned for the FDA in the second half of January will lead to surprises we don’t know of course. But we have seen a very consistent reaction from the FDA in all our interactions. We’ve met with the FDA on the 24 of January.

We’ve met with the FDA on the 14 of May, middle of September on the 22 of October. We had telephone interactions in between and the interactions have been very, very consistent. So, we would be surprised if that will lead to different outcomes in such meeting.

So far the guidance which we have received is that these confirmatory trials should be underway at the moment of anticipated approval.

Then regarding your next question about the dystrophin and where to sample biopsy, in our PLOS ONE publication, we have clearly illustrated that we feel that you have to really look at biopsies from the same muscle group and also preferably from muscle in a similar state of disease.

And the moment that you go to different muscle groups, because we know that the expression of dystrophin can be different depending on the muscle type and muscle group and it becomes an overall factor which could lead to noise in there.

So regardless from what we have said, the FDA thinks about it we feel that it would good to go to the same muscle group and the look up muscles of the disease stage and to try to really have the circumstances as similar as identical I would say as possible for a pre and post-treatment biopsy as we have described in our PLOS ONE publication in the methodology..

Thank you. It appears there are no further questions at this time. I would now like to turn the floor back over to Mr. Schikan for any additional concluding comments..

Thank you very much, operator. Again, I just want to conclude with a few remarks. We couldn’t be happier with the progress that company has been able make in recent months.

And I can assure you that the entire company here is working tirelessly to ensure that we keep our promise to the patient community and provide access to much needed DMD therapies as quickly and efficiently as possible.

NDA of drisapersen is well underway and we expect to complete the submission in the first quarter shortly followed by marketing authorization application submission in Europe. 15 boys are now back on drisapersen treatments and we are doing our best to extend treatment to all those wishing to re-initiate.

Our confirmatory study designs have been finalized and are expected to commence in early 2015. And we are seeing -- we would be – we miss not to acknowledge the immense support that the patient advocacy community has provided.

Their unwavering encouragement and collaboration has reinforced our commitments to the company’s mission which is to fill unmet medical needs for patients with rare genetic diseases. Thank you again for your interest in Prosensa..

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