small biotech former company now in public on the strength of one particular drug called the world with the drug or class a drug that was had a history of side effects involving cardiovascular events as we put in our complaint there were quite a number of scientific articles out market which suggested that there was a potential link between this particular class of drug and cardiovascular events think the inference in our favor is that because this company changed its clinical trial and said that we are now going to start screening for adverse events relating to one clotting needed she seriously just said adverse events  that certainly now changes the game and raises the level that they understood that there was this potential connection and what it did was it changed the worse profile of this company so what i'm going to invest in is going forward yes  best run on deciding whether i want to invest in this company and as we said they raised two hundred forty million dollars from the public in remission secondary offering based on results of this trial instead of reporting further adverse events from this the time that there was any scientific evidence or statistically significant evidence that these events were caused by the drug but i think the supreme court's decision matrix makes clear that you don't need to have statistically significant evidence before there  after all why would you tell your investors we're going to change our protocol and we're now going to strip two series of vans right in but they changed the protocol because of the two series of events  this company and assessing whether they want to make an investment once to look at the very same information but ultimately it's going to go to the f d a they're going to look at it to decide whether we're going to get approval after all that's the morning that's my understanding benefit calculus for the investor in from a just very briefly what happened at the end was there was a report of a patient that died stock price fell then jeff zucker issued a press release saying is conscious intent intentional fraud or recklessness and recklessness is defined as an extreme departure from the standards of ordinary there such that the defendant was aware there was in danger of so the fact that the two other events are non serious is fortuitous that they could have been serious had the curd elsewhere in the body and so therefore there is i understand the rationale behind the argument it would be that the clinical investigators designated each of the adverse events is not related to the drug they also gave factors and their diagnosis which is superficial to the surface of the skin there was no suggestion as compared with a pulmonary embolism deep vein thrombosis on the two serious adverse events that is superficial you know could be caused by a blow to the arm or leg had anything more to it  october sixteenth twenty fifteen conference call which is referenced in the complaint said that they had a dramatically different and the superficial one is either not treated at all or treated symptomatically so an aspirin or where he didn't see the necessary it could be supportive of but material information one is not sufficient for c enter in this circuit but certainly this court has repeatedly held in ariad in homes where that six hundred materiality are linked such that  ask yourself the question that when they said we're not disclosing all adverse events we are not disclosing all serious adverse events we may never prove cynthy and maybe some of these undisclosed to look at the disclosure in the record it said there were no deaths or serious adverse events possibly probably or definitely related to before so they were all designated as not related they were too serious  infer from zero facts that anyone discussed with dr hughes or that he so much ever had anything influencing him as to disclose lesser events see enter just isn't a close call on this one under deficiency letter f d a inspected a manufacturing facility and found some deficiencies the company didn't disclose it there were three bio reactor failures in their manufacturing the company didn't disclose it what happened later was the f ultimately issued a warning letter and the company disclosed it based some of the same issues that were identified in the deficiency and this court said in genzyme that the significance of that information only became apparent much later after these subsequent events and you can't look back and you have to look rather at the time the statements were made and say what is alleged in this amended complaint complaint that dr hughes knew at all related to these undisclosed two trials to come and as we all know the totality of the safety and efficacy of the company was not making it plain that drug was safe at this early stage so we submitted that sea enter is not at all present in th markable proposition as the supreme court noted that there are no bright lines for materiality so all it said was statistical significance isn't a bright line we don't rely on the lack of statistical significance events if you hold that there's a duty to disclose every non serious adverse event and the classical stage of the action is critical here because the companies in this circuit transparently and voluntarily filed their new drug application even with f d a at what they try to say is here's the information we think is important whether they were right or wrong in hindsight eighteen months later is beside the point because here  the lesser adverse events that comes saying there are not other questions thank you thank you