specificity full city with regard to public statements on a drug approval application before the f d a which i think they called maybe it may just need my own inability to come to grips with this case with this type of case but it seems to me that the nature of the case not a specific matter which you said you were at a series are a handling of represent clients in the forest but this type of motion to dismiss adjudication is not real susceptible to a rule argument of this kind given the nature of the various keep us here for the rest of the day so let me let me just start by asking you this as you look who listed at your complaint what is your strongest were are your strongest had approved drugs just based on proof of efficacy unsorted endpoints which means that if you can show for example reduction of course of cluster all or triglycerides in the short term study what they would do is they would approve the drug for marketing and then require you to do a post approval study to determine the wrong term efficacy and one of the doesn't ask and he needs nature of my limited historically and i'm speaking about the year two thousand so you know that period of time the everyone who was in on assumption that that there was a correlation right right but the f d a i told them at the meeting in july two thousand and eight cautionary you know we're just embarking upon this and you know these studies are going to give us important information you know and we're probably not you know we may not do something until you're you're underway with another study what what exactly how knew different well investors thought that when the anchor study was released which so which a proof of efficacy on growing triglycerides that the company would get approval to percent but the company never said we're not even going to have to embark on it did it you know they said that it had to be substantially in rolls but they didn't say it had to be completed and they didn't say that completion was a review issue so the just looks like it's just never going to happen he would've put the stock at the price but it's not only bad fact it was also you know the chance of this drug you know at twenty dollars or whatever that this drug could you know do a lot for people like that you were misled that's the threshold issue and only if you were misled do we then decide whether there was a tear or what you were calling your misled would have been material oh i agree  do and to be completed which would currently cost about two hundred million dollars and six years but by telling amarin that they had substantial uncertainty and we're actually amerinds actual work substantial uncertainty indication until six years hence at a two hundred million dollar investment that's a very different investment calculus that investors reasonably believed as they did based on the defense public statements that there was  a would approve the drug based just on surrogate endpoints and if i may this is this a reference that we had in the complaint in the precinct but it might not be as apparent there was a teleconference on april fourteenth two thousand and eleven or about the time of the release of the anchor study in which the f d a told the representatives from amarin on the call that it an advisory committee would be necessary before approval could after the advisory committee is that most possible there's nothing in the defendant's public statements where you would see that degree of risk and they basically said that we followed the s t a to use the words that it's an strategy that the want term study will not be required to be completed that triglycerides are approved surrogate end points and all of that is an absolute fool's good to create a rouge in to allow them to sell sufficient amounts of  representative of the f d a dr jenkins about why it was that the anchor s p a was identified as a review issue that my my my adversary it review issue including the history of the use of surrogate endpoints and a statement that the f d a made clear to anyone at the july two thousand and eight meeting that they were in the process of reevaluating use of surrogate  and what they do is they just cut it out from the middle of the very long paragraph the sentence quote at the time of the pre i and game i end the meeting on joy in july two thousand and eight clear to amoraim that they were still concerns and then later in that same paragraph it says the f d a made clear that it was aware of ongoing outcome trials might my adversary in this in the same way that he takes this these words out of context and in the complaint is paragraph one thirty seven it's on page j's three seventy two to three seventy three in the record in the same way that he takes the good in this  right not giving it the proper context is the same way that defendants in this case said that they were given a clear path to approval by the f d a whereas the f d a said that it school which is the nature of these absolutely and i don't think it is anyone's fault but i think there are two absolutely critical decisions one is this court's decision in the city of edinburgh case from two thousand and fourteen and the other is actually the second circuit decision and tom because both of those cases were evaluating motions to dismiss a ten week cases in the context of the f d a as drug approval process and was asking fundamentally the same question that you are now t to the extent that what you had was the on going process there that you have here and that that that ongoing process should not  test and yet he actually even said this is going to be a review issue our assessment of your drug and your rate basing it on a single blind it as will be or if you wish you give the expense of the testing  that is required we're f d a approval it would seem rather absurd not to have some measure of optimism that success if you're going to spend all that money the allegations here and i want to focus on the two but they spend the most time briefing in the most time at argument today what could you do you would do this and tongue that they talk about the fact that there was nothing there was no if the feedback that was out of the ordinary or presented a special challenge not of the kind normally confronted here your opponent talks about the press release and the package and it said it knows no issue when in fact it quote was based on the accumulation and totality of the scientific data and information including we have valuation and improved understanding of the relevant scientific knowledge this court has rejected since the days of the wiener eleven the f d a granted these special quota call assessment agreements the first one in two thousand i was for interim and the f d a said it would make it a review issue analyzing the results of the twelve week study and the fact that they had the outcome study substantially under way if the example at that point that the a change its mind because science was developing and they felt you know what we really need your outcome study results completed then they would have said it was a review issue they would have said no we will not consider granting or indication job on your twelve week study and being substantially underway and then in two thousand and eleven additional studies are coming out but the second special protocol assessment agreement is granted this time for amerinds outcomes study reduce it and yet again the f d a says it's a word the issue will contemplate and consider and what happens is october two thousand and thirteen f d a touch all the science together in the document that actually is that and the question is were we sitting on information from the f d a that had made it a material representation the f d a never said you have to complete your reduce the study f d a never put together all of these other studies and concluded that you know what now the world has changed and that the decision from dr jenkins and twenty four team which is relied on so extensively in the complaint is a perfectly good example of them saying we're putting we were told that the whole use of surrogate endpoints with regard to repeat profiles is being reconsidered theme which is that statement that the whole universe is being repeated i didn't see that waiting then we're anxious to see them because it could really be important certainly nothing conclusory one way or another about that well but it's important information and then we know from the record that a quarter name hybrid both unsuccessful even though this question really is one of legal policy but it certainly goes to the nature of this case and the nature of the arguments that you were advancing why shouldn't we be concerned here what you are really advocating is some kind of containing reporting requirement of communications between the f d a and pharmaceutical companies if you choose to speak on a subject matter you have to speak truthfully there's no there's no certainly amarin could have said that whether or not the one term to sit study is  these if the companies pfizer and snuffy determined that the additional studies weren't warranted they wouldn't they want to spend the money so i think there's an element of good faith in  was something good and they should have disclosed something with regard to face to they were sorely should be sorely disappointed because pfizer specifically said if i just pacifically said you can  were taking so it was not a question of deceiving it investor and in that particular case there were thirty two sophisticated opt out plaintiffs if i let you go one night i will have permitted the redefinition of quickly