opioid on the market that includes label limitations the c d c recommended after seeing signs linking duration and dosage to death review of this or her presence heartland ethel core and state farm issues for the court because the order on its face reads reasonably what i would like to do today is cover fundamental view violations that are inherent in the order and with the court's guidance i hope we can work together to unpack to understand what really went on in this proceeding the st violation reflect is unwilling to this to engage in chronic level an issue that's at the heart of the crisis under the c d c studies but the agency does not want to engage because it has approved these labels for fourteen years suggests that our product is safer than conventional formulations with respect to the risk of abuse that's the sooner they get what our claim to in this record is sort of an april t fact that we put in no evidence whatsoever that di would deter an actual drug abuser out there in the world from injecting or formulation or sorting it to talk on things and then i'll move on to the real evidence that i think will move the court i hope th against the e p a s point is that that's false and misleading because there is no clinical evidence to support it says we're not claiming any clinical because so now they have to go to there is no evidence at all the statement you just read and that's what i take their position to be that we have no evidence at all that there's anything physical or chemical that would turn the two of us here's where i'll give you the record sites we can walk through because study which is contemplated by the statute because it is a controlled and beautiful study found and i'm quoting from page four hundred and seventy three the difference in purity results are statistically significant between our client's product and the reference product and if you turn to page four hundred and seventy five he explains at this point and related to abusive terms he says the percent purity results for our product show that in mark have sole the active pharmaceutical the thing that you want to get high cannot be effectively extracted from the formulation matrix and iraq's a code on it can and on for seventy  solubility as the other except that don't give you high that five mils is filled with less pure in p i than the competitor product he put this in the record and more importantly if you look at jamie a five  states exactly the record study i just walk through now they say nothing about this we are not asking the court to look at the study and agree with the chemistry when i'm asking the court to approve the label of the product i point this out because there is dispute about whether it's necessary for an applicant to do more than a chemical study to get this kind of label anarkali position has always been you need more you have it or you don't need more because what they want in that guidance is to go and test how the user might react to it we don't do pre market test might actually injecting people as a medical and dangers so the only kind of study that we could have done beyond this one was to get a bunch of recreational drug users in a room when you do basically what they call a lighting survey for additional point to do the kind of study it's not scientific or controlled under five or five now f d a disagrees but that comes from their guidance we said you can apply that is law and we have a threshold issue under edison we should go have a hearing on it and here they've denied us this issue in every form you know the citizen petitions the other docket this if you don't have standing here we have standing we need a core part of our application we hammered it from an april th team jay sixty six to sixty seven right above the sentences you read is that acute use indication they don't want to talk about it because that leads to a very difficult place for the agency but we need to do more of this point and better than playing administrative gotcha with the process applicant to avoid confronting this tough issue it is a tough one but we just the government has proposed labeling stating that its product is gentle no it is formulated with inactive ingredients that make the caps and were difficult to manipulate for misuse and abuse and shortly after that humorous propose to state that individual physical product was labeled for acute use only and that you know even if the product if the labeling made some statements about you know the effect of long term versus short term use on the risk that people would become addicted something like that relying on parts of the joint appendix that they did not focus on in their brief but they don't they also you know don't alleviate the fundamental legal and deficiencies of p r s's new drug application for example gee if i have ninety i we say in counterpoint the purity point i mean which is yes you can get more solution it's like ninety eight percent to ninety this is only pretty so to get but what the ignore is what's right next to it on the purity study we said but because we these exceptions with the same solubility when you fill up your needle with five mils of that solution you only get us much smaller percentage of the a p i in our solution then from there is so for the shooter they're not going to get the precedents addison and so i haven't they don't have an answer to that ok so at a minimum that's the thing that should go back and the thing is i want to stress though is that that is not really the issue they're still going to succeed in dodging a fundamental state for an issue a fundamental public health issue a fundamental fairness issue to the applicant if they're curious also know about the use indication be it's under their own interpretation of the statute and what it's supposed to do see if this market offering makes sense as against others