not expressions of confidence but rather the defendant's representations of what the actual data was that for the safety profile this case is clearly in that latter group and that does give rise to a strong  science and i would direct the court's attention to paragraph seventy four of the complaint which deals with defendant hard statements and was asked about the drug tech which was a predecessor a similar type of drug that had some serious liver consequences after it reached the market and he said that among the consequences of that was liver toxicity and then comparing slippery mice and some produced drug to tag he said that all of our trials we've exposed over two thousand people do slip through mice and no one has suffered those types of problems i e no one had suffered liver toxicity even if you take the most conservative view of the record here and eliminate the twelve other cases that dr african found constituted liver toxicity there is one case of significant drug induced liver injury that cannot be disputed even the the word drug induced the phrase drug induced labor injuries that the same is liver toxicity here for purposes of this case yes you are drug induced liver injury is injury that is caused by the particular drug that was actually administered i understood i mean what was in a reasonable reading of this record that the defendants in this case understood that term to mean a finding with respect the highest law and not necessarily elevated levels of liver injury  law is a very extreme form of liver injury the f d a actually defines it as liver injury so great that recovery may not be possible in some patients when you use the generic term liver toxicity which is going to encomp lot of type of injury you can't say that you turn around and say well you know that is actually a very specific type of lives that we're talking to do you have any other incidence of it was it just of course every every case is important but was there one out of one thousand four hundred and seventy patients so whatever it was is eleven situation of this particular type of injury and dr africans do you have any other cases or is it just the why of that specific type of injury no there was only the one there was only one that's correct is that it seemed to me that there may have been some of the  not sure i understand exactly what each of those processes involve seem to be that there may have been some confusion about the different trials and that he was speaking purely about c a b p you are a defendant hon was not speaking about specifically about ca because he said that we had exposed over two thousand patients to slip through mice and that is far over the number of patients that were exposed in terms of the ca p p test themselves i think it was one thousand four hundred and we provided a chart that demonstrated that in the reply brief so there is no possibility that when hans spoke he was speaking only about those particular tests he was in compassing the entire population that had been exposed how do we know that we know because of the of the number that he trials well they're treating different conditions is community acquired bacterial pneumonia and the c e o p d is is a more serious condition of chronic obstructive pulmonary disease i believe and they have different shouldn't have changed the f d a is mind but the thing is is that their view that that should not change their mind doesn't allow them to misrepresent what the actual data is and that's what they did in this case and misrepresent anything to the a defendant hans spoke and said that in none of our trials has has there been any sort of liver toxicity you know investors had no way of knowing what would later be submitted to the two to the f d a and i  the rats had developed cancer and the defendant company and the executives in that case believe that that could be explained by some other theory and so they said to the public that all of our animal tests were favorable but the th circuit you know went out of all that case realized that they were not allowed and this is their holding in fact you're not allowed to misrepresent what that data is because you have a theory as to why the care or you've met your burden of making a showing of center don't we have to look at the context of the rest of the statements that were made to the investors you do you determine whether the inference of  one this is more than a core business this is basically separates hope to actually make money and they had anticipated revenues for this particular drug of two billion dollars they have lost two hundred dollars i had two hundred lawsuits prior to that that was a key fact in the in the sparing case from the th circuit where they said you know this is basically the company's only hope of turning a profit that's number one number two the comparison to key tech was a very significant factor for this company from the very beginning if you look at i think paragraph seventy seven defender fernandez said that we do we need to deal with key tech from day one so of course they're going to be familiar with what their research showed number three each of the defendants actually in detail address these results so they had to be familiar with them because they were represented to people that they knew them your for instance defendant hot and says ok we expose two thousand people to this that spoke about the two thousand people who have been exposed but didn't know what he was talking about that would be reckless too and that's a specific holding again of the six circuits decision in a sparing also all these defend a new that every human exposure whether it's c o p d or a c a b p or the national sam every exposure is turned over to the f d a so therefore they had to be on top of all of the evidence because they knew that it would all end up with the f d a one point and finally there are regulations that require that the company be notified almost immediately if there is a some sort of severe result as was the case with the c o p p patient who suffered from hepatitis and jobless which is as i think we've established so far is plainly liver toxicity although i want to follow up on the question of context and judge can and point because and this relates to the earlier question i asked you about liver talks city and exactly what the parties understood that to mean it seemed to me that that encompassed a range of diagnoses i guess and so the question i had is whether or not in holland speaking about liver toxicity understood it to mean that range or to mean the most toxicity perhaps that means that's one example of liver toxicity not the exclusive one but i guess my point is there seems to be some confusion about exactly what that means and so how can we hold these plaintiffs accountable and in light of that ambiguity honor i don't think there's any ambiguity because when you use the more inclusive term then that's going to encompass more by how do we know that he meant that more inclusive term when he said well your honor i think you were entitled to our inferences in our favor as well why don't they in places sort of are a little bit different in this context where you have to make a compelling showing so i enter right here and i think that if you use the term liver toxicity without any sort of qualification so that investors would be advised that you are in fact using your own secretly using your own idiosyncratic definition that excludes certain things such as a case is as as as serious as this where there is john this and hepatitis that i think that that's an unreadable reading of the record and where you basically a tie goes to us so i think under those circumstances the term liver toxicity has to embrace something that even dr hold back described as a drug induced liver injury at j seventy six and saying that we're completing complete agreement that this episode of liver injury was attributable to the study drug j eight hundred and seventy five that's one of the defendants saying that and to say that that high on defined liver toxicity to exclude liver injury i think it's not a reasonable inference i see i've got seven seconds for rebuttal of support as for the question is thank you as this court observed in the th case which we cite in our papers when analyzing claims brought into the p s l or a plaintiff allegations should be viewed holistically those allegations are only a forty quote inferentially warranted by context and common sense and i'm going to spend some time talking about common sense and context because respectfully the plaintiffs are asking you to ignore let's not forget the context that the advisory committee actually voted to approve this drug let's not forget the context that the f d a said we're not going to approve it right now but we want you to get additional safety information and insert this drug and nine thousand additional people let's not forget dr abbott can said the same thing we want you to insert said talk to me about key tax sordid past he said mr hahn said keep that involved visual disturbance exacerbation of improper muscle regulation and my friend focused on liver toxicity and then mr han further said in all of our trials nobody had any of those same types of issues that the folks had experience with he took what happened and he took the plaintiffs themselves pleaded paragraph thirty seven of their complaint they say the key test was linked to quote dozens of cases of visual disturbances loss of consciousness and here's the important part severe liver injury which resulted in liver failure death and liver transplant not any case in any trial ca b p c e o p d and i'm not making light of the hepatitis case i'm not and i'm not saying it's not serious it is but the fact of the matter is it's not liver that i'm sorry it's not the failure it's not liver transplant and it's not death due to due to toxic liver toxicity it's not the same thing we can't divorce mr han statement from that context but to cutely in response to it to a an impromptu question on an analyst conference call even if we get the point if the benefit of the doubt and say ok maybe that he didn't speak completely accurately that does not equate to he meant to defraud securities fraud case because that really harvester cost of raising capital significantly and i suppose that's a particularly true in these instances where talking about develop developmental drugs it's a very long drawn out and expensive process to begin with and when you add to that the cost of securities litigation and so the development of a drug which would treat c a p b which affects huge numbers of people some fatally would be would be a very good thing regard this as a close sort of borderline case i mean i can i can see plainer side of it i can also see the idea that that given the medical terms and the context in which the questions were asked i can see the real possibility of confusion as to what was actually being talked about and the question and the question i have is whether the statute should be a time breaker in  case where if we were to impose liability for every bullish statement that a pharmaceutical company said we would choke off the lifeblood of of medicine and innovation exactly what the p s l are right in congress to maintain we didn't intend to  case my friend talked about no contemporaneous conversations with f d a the f d a was telling the company one thing and the company was telling investors something different that would that would get there maybe if it for example if for example the situation here was the f d a told the company in real time we're very concerned about these a o t l the patients were very concerned about a signal of liver toxicity and then the company went around and told investors no problem we don't think we have liver toxicity we only have able to elevations that might be zach that might that might be sure maybe it might be a sparing but that's not what we have here we don't have any any any allegations about co yet nor do we have any allegations from so called confidential witnesses we have nothing about judge kane and you asked you asked me rather talk about condom and what he said was well it's an important it's an important drug to the company ok and he cited to a six circuit case that's great but that ignores cause a really who dealt with that exact same scenario and said that a motivation that is common to every single executive in corporate america doesn't lead anywhere near scienter and he also said well they were familiar with the clinical trials for sure i'm not going to back away from that they were definitely familiar with the clinical trial data but what did that clinical trial data evolved from the filing of the complaint and certainly on appeal so let's talk about that c o p d patient and let's let's remember that the county wasn't seeking approval for c u p d they were seeking approval for  trial where they were where the company was studying optimal doses for long term dosing c o p d was dosed at four hundred milligrams a day for twenty eight days the one patient that they focused on d patient who who contract a drug induced hepatitis started experiencing the system after the symptoms after twenty three straight days of dosing four hundred milligrams a day and i'm not suggesting it's not important serious it is but let's keep in context what the company was trying to get approval for and that's also keeping context when the company made statements to its investors what were they talking about they were talking about what they saw in this in the face  they didn't see he didn't see anything like that in this phase three trials and more importantly they didn't even see one now one serious adverse event related to liver toxicity and all of the i mean clearly you've got a problem with his statement and i think your best argument is look at the context of everything but i'm having trouble with the point you're making now i don't quite understand it ok so i'll go back to mr statement was kind of where a story if you could talk directly into the like oh i'm so sorry yeah i'll go back to that statement and and again context i agree with you context is important for all of this and he was asked the specific question from an analyst what plaintiffs pled and that is liver serious liver toxicity that resulted in death of a transplant and liver failures right but they're not limited to i agree it's not limited i agree but it  was those kinds of cases that led to congressional to congressional inquiries that's a pretty sordid past it's those kinds of cases that led the f d a to realize that certainly true certain certain data from the key tech clinical trials w fraudulent and they had to and they had to take back from that that's not what we're talking about here and so if we look at it in that context and mr hans statement you asked me if and i'm going to say is it reckless certainly not is  he have disclosed to hepatitis example that one case out of more than two thousand people that that was that participated in all the various trials perhaps that would have been ideal but that's not the standard about and i i i do think it's an important point in your favor that in the c a b trials there were no cases of live of toxicity and i understand that to be under  we were talking about something that is really a very serious public health threat and as i say the the development of new any buyouts is really running only one short step ahead of bacterial resistance and i'm a i now worry if in addition to all the trials and all  the the process it takes to get f d a approval it can take years it can take very expensive trials it's a long expensive process in every way and that's a deterrent to developing new drugs and if you power on top of that not securities fraud suit and the expense involved in that i think we may be developing we may be deterring the development of very very beneficial treatments if we  approval thanking the f d a is not going to approve it but all i'm saying is i do think congress was cerned as a bottom line with not putting too many impediments in the development of medical treatments that could bring a lot of good to a lot of people but i think congress having this kind of this kind of suit this is on the page i agree agree with your comments wilkinson and i would say it's not indorsing of course a position that nevertheless a pharmaceutical company could go out and lie to its ok i think your your most persuasive point is the statute i agree that's my most persuasive point in addition to you in addition to the case law that says that we have to look at these statements in context and if we look at all of those come out and we look at that context you know drug discovery is inherently risky as you've noted there are going to be some positive things and negative things if the if if the company was if the company i see my red joy if the company like it was duped like in zack with these other cases that my friend cited that had the company had discussions with the f d a about one thing and told investors something different that's a different case but that's just not what we have here at most we have a disagreement but interpretation of that kind of a trial data interpret and a trial data that was fully disclosed to investors i think you  act one of the defendants everyone agrees that this is not merely liver toxicity that these patients suffered its actual drug induced liver injury they had to take the person off of the drug so it's not a question of interpretation at all if there's one point i'd like to make really clear is that there are plenty of cases saying that it's ok for companies to express confidence and i accept that and i understand that but when the rubber hits the road to  to a telephone question or rather to how did it come off it was an analyst question i'm glad your honor asked that question because my friend described it as impromptu the last thing that a question about qi tech would be for this company would be impromptu as defendant fernandez said ten years earlier when they started the company they knew that they had to distinguish the tech i counted and i cited them in the brief four separate times where analysts ascii tech related question i believe that it's on the market with a very limited label but didn't didn't have a pattern of liver liver damage and wouldn't want a comparison fair comparison be trial records slip through my sins is worse so clearly they would be concerned and the f d a would have to be concerned in terms of approval and investors would have to be concerned about the ability to distinguish key tech because that was ultimately going to be the deciding factor and what happened here is that not only with the defendant hans statements but also went to defendant fernandez and defendant old act we're talking about why they changed the dash protocol they  the information about the start of the patient that suffered hepatitis from their reasons for changing the nash protocol and the district court found that to be misleading to investors so there is a pattern here which is similar to what happened i believe in sac where there were there were misstatements and there was also withholding of the f d a as actual recommendation here we have two instances of the same fact not being disclosed and my friend also conceded that all these defendants are intimately familiar with the with the record here of the results of their own trials so when defendant hans says two thousand exposures there's absolutely no question that he's talking about everyone who received that drug including a person who suffered liver injury and liver injury cannot be defined as being excluded by liver toxicity as a term so if there's no question that they're misleading here on the most important facts the having to do with the potential approval of this drug and i'm not saying that that you should somehow hold against them that they want to earn money what i'm saying is as we the case in the experience case from the six circuit where a company is has basically lost a couple one hundred million dollars and they're looking at a potential revenue stream of two billion dollars this court can draw the inference that these executives would be extremely familiar with their results i thought there was a case law there there that said that the desire to raise capital doesn't feed into the city enter thing i  i understand there are that is that case my point is a different one which is that when you have lost two hundred million dollars a year but i mean what you can do is say that the desire to raise capital which is present in every developmental drug case i mean and obviously when people are raising capital by and large they give an optimistic view of the company's prospects and  my last point would be that this case is virtually identical to shuman and should have been they misrepresented what the what the actual data was because they had a theory as to why that didn't matter that's exactly what we just heard from my