every viewer uses images to determine how much dystrophin appears to be present in the staining on the slide and the parties in this case do agree on one thing and that's why you have to put the plaintiff's allegations in the contents of of what was going on at the time and just prior to the period to show house arrest to misled investors and twenty fourteen now on twenty thirteen in july of twenty thirteen the f d a didn't tell us or up to that they were open to accepting for the this is just a thing quantification but they did express concerns that it was obtained that it was obsessed by only one reviewer and that as a result of this image interpretation was susceptible to bias and that it required thirteen a related drug trial for the drug first a person fails and the f d a goes back to strips and says you know what our concerns about this about this just in data have grown so in february of tw concerns have grown on march fourth twenty fourteen and this is the first day of the proposed second amended complaint class period the defense announce supposedly extraordinary dystrophin data they say it twenty four weeks for showing twenty percent dystr at forty eight weeks of treatment or showing over thirty percent of the serpent and they further comment in the context of announcing these results they say this was all done on a blinded basis these were bred on the vine and basis without knowledge if it was a placebo complaint and in the briefing documents that were attached in support of that what we learned was at one twenty four in fact blinded results showed essentially no change in dystrophin intensity for any patient and it was only out of the blind was broken the images were were magnified at an even larger scale the whole scale and positive fields meaning the quantification of certain quadrants of these images was supposed to have been selected randomly selected only positive fields to quantify it you said was false which is the march or statement of paragraph one twenty didn't use the word blinded at all that you do as you said the you need to have some trucks to position of what they said and then what the truth is that we need each other head on show your honor so  and then he goes on to say and these are what those results are twenty percent thirty percent this or that so now it seems to me we just saying unlike what you initially said the statement is the misstatement is saying that they will blinded because the to submit and the a by the year end of twenty fourteen and it was misleading for them to also say that we can file an n d a now because at that point a independent confirmation of that state that it should have been a relatively simple thing to do by the way to take their just something images to send them to an independent lab and to have them and to say here our dat verified they purposely avoided doing that throughout the class period because we allege because the way that the study was contacted they knew it was unlikely to be independently verified by any independent and sixteen we knew that advisory committee hearing that had been scheduled for january was instead going to be held in what was going to be at least scheduled to end up being really held in april we didn't feel that at that time that immediately jumping to amend it was the best tack to take however i would say that the later revealed facts that we added to the proposed second amendment complaint merely confirm as a factual matter that the inference is that the district court drew  paramount to guarantee access to the courts and i would say here where there was a relatively short time period that last between the release of the information and when we brought it to the court's attention and i would hope investors would not be punished for that where we did pre screen on behalf of what i'd like to do is spend a couple minutes talking about high level what happened in this process over the course of the five years and then i want to get into the misstatement argument and then fin terms of what happened in the five years but the process by which this drug was developed started in two thousand and twelve it continues to this day there are still a number of ongoing studies the drug has been approved and there are continuing focus on a particular timeframe in this five year period which is two thousand and fourteen april to october of two thousand and fourteen in that time period all that happened is they came out in april of two thousand and fourteen and said hey in the context of this long roller coaster journey we have now met with f d a over the course of the past four or five months and we are in a position where we can tell you our predicted timeline for filing if they're saying there's a chance we can funnel it by the end of the year and they know the condition it's necessary to need to file into the year and they know that they are not going to satisfy that condition and they would be in the state to say that there's a chance of making the right so they're how do you respond to that there are several points number one is they point to nothing and can point to anything that as of our april press release or at any time between april and september of two thousand and fourteen was there a requirement that we do an independent verification of our dystr prior to filing an n d a there is nothing in the record in fact the only evidence in the to september time period april to september of two thousand and fourteen the only evidence of whether that  up to therapeutics has publicly announced its intention to file a new drug application for a ten percent by the end of two thousand and fourteen as well as players to initiate several additional clinical studies with the test worsen later this year as mentioned above we are willing to explore the use of all potential pathways for the approval of drugs reducing muscular dystrophy including accelerated approval as appropriate nowhere in this formal statement you know they take issue with the fact  complying with how does that statement help you have to be able to know whether you're complying with the condition they just know they impose the conditions no no after you know exactly where we are in this process so let me back up and explain what i'm so what what happened is going to work we can prove it because our boys are walking are taking this drug and they're walking longer and we think we've got some indications of dystrophin that are sufficient so we announce in april based on the discussions with the f d a that we think we can get this done among other things that we are we are we have disclosed to the market in april very clearly that the f d a is very skeptical of our district and that right we were very clear about that  we remain skeptical in a certain whether it can even serve as a as a surrogate employ those are those are the words that the f d a used and we quoted them back to the market verbatim we just relayed that her bail and then what happened and we said we're going to work with  intil your work is complete right all of your studies have to be complete and then you file it and it's a very non fluid kind of binary process were complete then you can file work not complete you can't file world accelerated pathway which is far more fluid and the f d a even says multiple times in its own statements that we could we could file portions of an n d a and have the have the f d a start reviewing portions they would do a rolling review they said that even in their october two thousand and fourteen press release the f d a said that they were just in the because kids are dying they said we'll review whatever you've got that you want to file as we decide and it's consistent with that statement you were focused on we decide rather than filing portions of this we're going to file one full clean package that is persuasive as persuasive as we can be on what's going to be clearly a close it took a call here and then we and we did that in june of two thousand and fifteen and then what happened was that the f d a reviewed that clean package and two months later in august they accepted it that means they're saying it's complete that's what they're doing when they say we've accepted with them singly that in that statement they're your proposition is that statement would not have been understood by an investor as a statement that we were going to file it so that it would be accepted it was just we were going to something that might not have been accepted for finally we are saying we can we can file it and they can start reviewing it and make us continue to do work but they're not going to accept it until we get all this done and accepting her friends different still than approval sure so accepting for filing means means nothing other than ok you've now given us all the all the work that we now need to do for approval we're clear about that in our disclosures by the way we say over and over again filing  doesn't accomplish what we need to even if even the f d a accepting the n g a doesn't accomplish what we need to we actually have to ultimately get approval and and even there your honor accelerated approval doesn't actually accomplish what we need to work in that different of a process here where they could they could accelerate approval and then while we're doing these confirmatory studies and the kids are taking the drugs for a longer and longer period of time it could happen this is conceivably possible it could happen where they say you know what we're actually now seeing safety issues arise where we don't think it's a april  next steps in the process are the f d a says ok the next thing we need to do is determine whether to grant accelerated approval in wow all of that is unfolding while the f d a is really that statement is referencing approval as opposed to acceptance ways and it's a nuance in the context of this five year process but they say we want we've gone to the site and we've looked the f d a is what at the site themselves they don't quite get comfortable we're requesting that you do an independent verification with her parties and try to get it down as early as possible so they said get moving on that's what they tell us at the barrier to july and then in september we have a meeting with the whole purpose of which doesn't that render fultz the continuing assertions that they're going to file an n d a now and this this is why there's there's focus on the august seventh earnings call because otherwise we doesn't speak about this process until september so there's only one earnings call and that earnings call the c e o of surat this says we were made on track in our view we're going to meet with the f d a in september and they are going to we're going to talk specifics about what's required for the n d a filing we remain in collaboration with them about precisely what needs to be done for approval not not for filing the n d a and then in to discuss what needs to be on the actual submission and then he says and this is the paragraph that matters the agency recently completed completed a site visit with nationwide children's hospital in columbus that's where the district and was read and met with the leadership in sap of that has to pathology lab that conducted her dystrophin analysis and quantification and we continue to work with the f d a to provide greater assurance of the quality and reliability of our dystrophin data in anticipation of a potential  decision in potential and a review next year so at this time what what he says is exactly what surat is thinking based on the request which is we can file the n d a by the end of this year we need to we need to do this this independent verification while they are considering it so that we can get a decision next year and then all that happens this is what this is what a i want to emphasize all that happens is that six blind you just think that doesn't mean it's not pointed right so the question would be if if one were to think that it's misleading to characterize a process in which the person doing the review of the stain knows that these are selected group is things that look promising if it's misleading characterize that is blinded you have a problem well what i would what i would say is that there's it was misleading to characterize something as blinded without saying hey just so you know this blinded study involved the review we're looking at a selected group of promising stain would you still have a problem i'm not i'm not trying to follow your nose question what you're care we both seem to agree on the way the study was done right which is that at the time and look at the stains it's not totally blowing in the platonic sense because actually this is a set of stains that have been selected as potentially promising that they're looking at ok you nonetheless cure as it were the company characterize the study as blended without saying in characterizing it as blinded that the way it works is we look at a selected group as then one might think that's misleading you might say that's not that and it truly was not pointed in the platonic sense then there would be there would be an accurate statement i don't just to say i don't think it would be a material misrepresentation in the context of the securities case especially this one because all of that all of the review of the dystrophin data ended up being utterly irrelevant for purposes of approval when this drug was approved on was the basis of kids walking and you probably find this interesting that the references in the materials to two natural history studies is which which is unclear kind of a comment on space unless you kind of live in this world but what that is is essentially a virtual placebo so they say we don't have enough kids to have a placebo group so what we're going to do is are our twelve kids that are actually receiving the stroke we're going to go out and find in the world based on exquisitely detailed doctor records medical records the equivalent of twins for those for those kids we're going to and these are kids whose whose muscles are deteriorating rapidly and are not taking the drug and we're going to compare the kids who are taking the drug with their virtual twins were not taking the drug and it was on the basis of that clinical proof that the drug was ultimately accepted for filing and then approved going to accelerate a basis and so whether the review of the destroy the muscles in the in the arm it's just that it didn't ultimately matter at all in the context of this it's the clinical efficacy and the kids are walking longer then there are again the virtual twins out in the world who are not taking drugs and so i would agree with you that it would be an inaccurate statement but not here because it was within the range of scientific disagreement utterly irrelevant for purposes of of approval and  this was still blinded well there's a number of cases in the first circuit and i point to be amended number other cases that say you've got to allow for some regulatory back and forth that maybe it's just a tree fall in the forest this issue about whether the review was a line or not in that way which was never came up until january of two thousand and sixteen it never came up so what they what the f d a was challenging us challenge instruct on was not whether it was born or not they were just saying we're not even looking at it we've only got twelve kids here and even looking we're just not we're not seen quite enough dystrophin production to conclude that that can be as target in point so keep on working on the natural history that i keep on working on the clinical data points and we're going to go to the site in the summer of two thousand and fourteen working on the site and we're going to talk to the reviewers ourselves and see exactly what they were doing but that this will blind first non buoyant is i really feels a red haired it just never came up in any of the back and forth with the f d a again until there's a honest regarding the study behind the f d a learned at the site in may twenty fourteen about the process by which the data was reviewed and the fact that the blind was broken there is no response because we still have to then determine the futility issue a misstatement is one of the elements is i understand the backup argument that is basically materiality or perhaps even loss causation suggest that investors would not have cared at this time in twenty fourteen that when that study was assessed on a blinded basis it showed zero dystrophin production so hard the last causation so it's tied into a loss causation because how some have to got out and got an independent confirmation of the results that it was directed to do it would have known that it could not announce these results in march of and fourteen and claim that they were blind that they never would have even been able to get their position is not something that has been fully briefed on this issue because we didn't get to that point but that is directly tied to the issue of independent verification and again the reason that septa didn't want to go out and get independent confirmation was because they knew what was on my clie to be useful you also have to overcome the time it is issued right for this to matter yes so can we just go to and since you can buy anything that can be misleading either could you just address those two points sure you are well of course wrapped up was saying to investors we want to file something that is going to be accepted and that's the reason with our site team to see how it was collected it's going to be an ongoing thing we're going to make the f d a comfortable with this that you didn't really want to the scientists and understand how it's collected the f d a had already said we're