our overarching statutory argument is that c m s is current interpretation is clearly foreclosed by the controlling statute and if this court agrees with us that that resolves the analysis for all of the various permutations of the arguments that follow but even if c m s is interpretation isn't clearly foreclosed even if c m s has or could conceivably justify its action here there are still some fundamental problems with applying those actions to mallinckrodt in this case in order to work the kind of retroactive liability that mountain pride is facing here if c m s had use the take gather just nomenclature that's not of the regulations or the statute it's just their choice and their manual to talk about this kind of application for your indication for permission to use a new indicat but with respect to your question i actually think that was the question that was asked and answered in the case after it went back to the district court and from this court and what it ultimately found was that the drug in that case because it was a supplement a supplemental n b a and not an independent m b a did not warrant a new base state and based on that based on that difference but that difference matters here and label for which has not been changed in thirty years that's evident on the face book of the letter in the slides this product has undergone a fundamental revision both in the indications that it is used for we took thirty off and we added a significant one we justified the change so judge taylor not answering your question that way because that that was quest course proffered justification if it had gone in right now after at least the district court's decision and it's an it might not have an argument today it certainly thought it had an argument in two thousand and twelve based on the significant provisions that were under and there's but the truck here is i mean i appreciate what you're saying about the presentation that they that but this is this is where the government's in the district courts argument on retroactivity in particular get so interesting right because the statute doesn't say any thing about a distinguishing between or among types of th know that's i think our statutory argument is is a little bit broader than that our statutory argument is when the f d a in its expertise decides to classify something as a new drug application approved the application as an n t and as in this case by the way awards it seven years of marketing exclusivity sheet off of that and be a number that that has significance for purposes of the signing this as a new single source drug to b which is headed treatment of subsequently approved drugs use uses the term covered outpatient drug is there a difference between single source drug and a covered outpatient drug and if so what is that their friends there if there is no difference in what there is a difference in a statute between the two but for purposes  to be the provision that you just recited the covered outpatient drugs there is clearly just a shorthand for everything that followed from c to a and i say that for one particular reason c to be as you see directs that certain language in c to be replaced with other language depending on when the particular drug issue was approved by the f d a for marketing and because see to be expressly refers back to s it's quite natural that all of the description and see to a the amount of the rebate with respect to each dosage form instead of the single source drug or an innovator multiple source drug that's the rebate formula for those drugs that we're talking about in right because that question about what constitutes the two to sink source drug refers back of course to the statutory definition of single source drug which is back at k and eighty four dollars i believe and what single source drug says and this is where c m s was actually using as a jumping off point when it talked about a drug approved under a new at m d a by f d a this is what it was talking about the term single source drum means a covered outpatient drug everyone agrees acts are was that which is produced were distributed under a new drug application approved by the food and drug administration can't get that language is largely replicated in a statute with the additional gloss that for purposes of this definition and the drug rebate program and original n d a which used to be that language in the statute means an n d a other than it and approved by the a for marketing unless a narrow exception applies and we all agree it doesn't here so you're reading from the regulation no with what the last part of what you just said yes i am so you're not relying exclusively on the statute you're relying well as the whatever it is twenty trial back there are it does and there's a there's a technical reason for that and then there's a practical answer to that that the technical reason for that is that the way th up the medicaid rebate program drunk's they're not reimbursed by indication under different base camps they are reimbursed by the state amps so there's no distinction between prescribing for one indication or another the practical reason is under the medicaid program in particular the majority if not the vast majority of the prescriptions are of course for interim title spasms because so many infants are in medicaid the prescriptions record no i don't believe it's in the record i think it's i think it's publicly noticed but we could also supplement with an explanation if you need it let me have a simple question along the lines of text table simple question which i'm sure you'll think is over so i mean but when i read the rebate provision it provides for a new base state if i am pay for each dosage form and strength of a single source strategy drug and here we have a single source drug it's only made by malin crime and if the same dosage form and strengths are just as a common so nothing about that is what's doing the work for you it's only when you then delve into the definition of single source data and that's what you're alive same dosage from is frank and you're just saying well yes same position and strength identical drive but it's different single source drug because of the operations well i think i think because of the operation of statues is key that what we've laid out in our briefing and i don't think the government disagrees with this as a basic principle it just disagrees with the application here is that you need a different base state amp for each distinct a single source drug and each distinct dosage form and strength of a sin well sourced drug i think that follows quite naturally from the statute and it's certainly  backed up by the definition of single source drug but remember all of this statutory analysis that we're talking about that's the kind of overarching and how was says that i said if you agree with us that the statute is clear then we'd win across the board the problem i think the real fundamental issue that this court has to confront if it concludes the statute is anything other than clear in our favor is was it appropriate for c m s to apply its new interpretation retroactively all the way for them but if it's clear in their favor then there's no issue of retroactivity or lack of notice and in fact were confined to just apply it if it is clear in their favor and this you are correct what difference does it make what the agency said it the agent no authority under the statute to authorize a new bay state period oh i think it makes a great and if the agency administering a statute response to a request from a gravity and says you know we've interpreted x to mean  y and then later changes its mind you have to pay the money back what difference does it make what the agency said congress did not appropriate money for purposes of law during an agency makes it the agency has no authority under the statute or the constitution to authorize the expenditure of funds for purposes other than what congress appropriated for so that is the that's the type of hypothetical that the government is urging is a clickable here  administrative or different types of andy a's the government's current argument and i want to land on that word current for a minute the government's current argument is that because this particular new drug application was a type six new drug application and in c m s is estimate mation type six new drug applications are merely administrative and there's nothing that actually happens under them they have no function nothing is marketed under them remembered by the way this is the question th a the expertise you declined to answer there is nothing in the stat that talks about different types of n d a it says when a drug is approved for marketing under an n d a it's a new single source drug full stop now the reason i said current interpretation is that i also want this court to understand how much these arguments have evolved over the course of this case and over the course of the district court decision and appeal in the district court what the district court said and what the government said at that time was that c m s was mistaken which by the way is not a word that appears in the administrative record mistakenly believe that the f d a had approved the decades old x r as a new drug that was the government's argument below district court concluded c m s thought in two thousand and twelve it was approving an entirely new drug that can't be and the government clearly knows it c m s knew what drug this was new how old it was knew how important it was knew the value to the medicaid program of keeping x r in the program rather than having it meet because of course as mary read the c m s director of pharmacy understood this drug leaves the program states still pay for it under the early screening and treatment program still keeping the drug in the program was that the real focus of two thousand and twelve so now the government is saying well what we really were mistaken about and again mistake is not to be a myth street of record were this critical fact about the hundred rigs decision that the statute implicitly contemplates approval of a brand new drug an entirely new drug or you have to agree with the government's current clos which is while the statute says n d a while the regulation to judge will it just seems to a very arbitrary differential treatment and of different otherwise completely analogous decisions accepting new indications there have been many new indications except for aca are better as important medically and as you know supported by new information and as this one but just to put it most tendentious leave because that the form of this one instead of being you know supplemental an efficacy supplement it's called a type six and e s a which needn't be under the regulations or the statute but just because it is then randomly this new medication resets the base date and pay it just seems really arbitrary and not not defensible that that because f d a shows in this case to assign a new and da number to this and it might be helpful if i spend a couple minutes on the typing n b a issues because i think there's there's something that's important for this court to note in the joint appendix are expressly deemed not to be marketed under that new type nine and a number the manufacturer intends that the product be marketed under the parent m d a type ten is the opposite type ten is marketed under the type ten and a number and that tends to be applied as you'll see in the in the j a five hundred and thirty that tends to be applied when there are among other things significant labeling revisions type nine and ten  not a particular type of n b a but the n b a itself but the reason i think there's some irony in this judge taylor just as a practical matter is c m s is general approach to the definite definition of n b a as you can see in the regulation all of those drugs to be considered to be single source drugs because the rebate amount is higher for single source drugs than it is for generic drugs which a lot of these otherwise would be so there's an irony here in c m s saying well for this particular rely on that express guarantee that's essentially what the government is arguing and i submit there is simply no way to read that statute or that regulation to support that clear interpretation not even the district court could bring itself to ascertainable certainty as this court said in g e cannot work an unfair surprise this did all of those things to this particular regulated entity if c m s made a mistake if it made a mistake it can interpretation which it think the court should be afraid of oversimplifying the statutory analysis here the statute is straightforward as applied to this sets of facts i think there are two different paths you can get to the right result but the easier and more straightforward one is one that i think haydel put forward most cleanly which is to just look at everybody now agrees there is only one act are initially in this litigation they contended that actor was actually two drugs that if you look at the opening pages their brief now they describe x hours and all drug they got a new approval so everybody agrees line of questioning about supplemental m b a s and f c supplements which was squarely on point here and got to the heart of the matter which is what happened in two thousand and ten was an approval of an echo efficacy supplement of the new indication but it wasn't approval of of the federal food drug and cosmetic act now what happened in two thousand and ten was an approval of the underlying drug as safe and effective f d a had done that fifty or sixty years earlier what they did was they analyzed the this one indication this infant tylenol spasms indication and you can see that if you look at the approval they eventually got from f d a this is i'm reading the last page of the or i direct you to the last page of that approval letter instructing questcor all of the active maintenance you need to do for maintaining a drug there's periodic reporting requirements and other things you need to do to as your continued as you continue to be regulated by f d a all of that about what qwest core understood at the time i think if nothing else all of their concerns about being misled by the agency are largely provided by the documented j a for fourteen which is something that was central to the district court's opinion and yet  now in christ can even bring itself to acknowledge this document in its briefing here this is the letter and this is the rather the submission that now in christ made to the f d a to associate be the  y was in the definition of medically accepted indication excludes it from also being considered an approval of safety and because so i supplement that is not something it would reset the baystate and p and with good reason because the statute is directed to approval of the underlying drug not be iterative changes that can happen to the label and that  is not all that infrequent of an event as as i think judge noted acts are itself has over the years got undergone many labeling changes there have been many indications that have been added to the label that have been removed from the label over the years with f d a approval there is a process for ear in our favor but if you want to look at the two thousand and twelve letter i think it actually underscores the fact that agency just simply did not understand the true nature of the facts and in particular what it did not  clearly i'm reading from j a four hundred and fifty three which is which is the latter there is a clear distinction drawn in that letter between the quote recently approved x or gel and the quote original product and i think that that shows that c m s at the time did not appreciate that this n d a was for the denominated an n d a was in fact merely approval of an of a new indication and not approval of a don't think either entity erred exactly but i think you're talking about f d a potentially making an error and for that i think it's very helpful to look at the administrative record here starting with what f d a told mallinckrodt or at the time it was q  core up front when it assigned this because remember questcor understood it was just asking for a new indication so we didn't submit an entire new big n b a packet it submitted a supplemental n d a and at the time in two thousand and eight this is thousand and nine but in the year before that they hadn't adopted this new new approach yet they didn't have that solution so they assigned a new number for administrative purposes and they were very clear and that two thousand and eight correspondence with questcor that we're assigning a new number for administrative purposes and then when they approved it finally in two thousand and ten there was that language from j a for a laugh and then i was quoting that they said don't use this number anymore this isn't your number all of your reporting of your obligations tied to the underlying drug itself are associated with and are supposed to be completed with jay under the original and a number and as i said questcor was not in any way confused by  with us to use your new number and to market the drug when that's used for this and occasion under the new number if those were the facts would you win or would you lose then i think probably the bay state amp he would would be reset but i don't think it would be on an indication by indication basis i think it would have to be that there was a new drug product a drugs are not so or are not approved precisely because quest understood this to be just an efficacy supplement so that there are lots of the reason but the reason i'm asking these questions is that your friend on the other side talked about the drug to be marketed under that number so so since the statute doesn't define a new drug application the agency effectively then just either depending upon you know how they arbitrarily assign new drug application numbers or by regulation just basically change when the throat was previously address what what established criteria f d a may have for determining whether something should be categorized as as a type one or type and but i think we're turning to the type six issue  here which is i think what's central is the fact that mallon krakauer questcor was notified at the time that it was just administrative crap tracking number and the fact that this was put in just as an efficacy supplement and maybe there's to i was wondering whether your response to judge wilkins would have been would have been in the definition of the single source drone which is a covered one is i think i hope responsive to judge wilkins concern either you just get there by saying that it's not a new covered out a subsequently approved covered outpatient drug for purposes of c to be or you look at the definition of single source drug in case seven that your honor was just referring to and look at the requirement that it be produced and distributed at the point that f d a authorizes this as a new drug and is administer a new and providing the authorization to produce and distribute and market that drug under computer systems were set up at the time i believe there might have been just sort of a need to have an underlying n d a number to be associate with a file but the file at issue here is just the file for the efficacy supplement it's not a file for the the current folks over to the neurology folks i believe as a function of how their computer system and their filing system was set up at the time they needed to have a overarching number to associate with it in the neurology at the  p because it couldn't be produced and distributed in response to seizures unless it had that approval so it ends up feeling like the agency is just saying well because we told you to close that it you know it's very formalistic we said we're not going to refer to that anymore but you needed that in order to market it there where you're marketing  question of whether this idea well they put it market it for that specific indication but for the approval they received under the two thousand and six and the at and that point proves too much because that's equally administrative purposes only at the time that it was closed out it was they were told that if you look at the letter itself it's not reviewing all of the underlying drug or or purporting to reconsider whether the drug itself is safe and effective writ large it's only analyzing the efficacy supplement and then it's and we're closing this out and go back to using your original and d n a and if you if you're concerned about what f d a was saying later on and their confusion if you look at j or the drug was not a subsequently approved drug and also the authorization for the production and distribution of the drug itself flowed from the one thousand nine hundred and fifty two and yet i'm trying to understand  something can be both a single source drug and a covered outpatient drug a single source drug is a type of covered outpatient drug so in the definition of single source drug it refers to it as a type of covered that's what i thought so i mean earlier you said well here the statute the clear and simple application of the statute is to say that this using the definition of single source drug that when we look at the language which is produced were distributed under a new drug application approved by the food and drug administration in that sense so it's not a single source drug but that doesn't necessarily mean that it could be a cover the how patient drug it doesn't necessarily inherently the subset of covered outpatient drugs is larger than single source drugs but there is no circumstance under which acts are would be like a multiple source drug or internet or anything else and i don't think misstates and will argue otherwise so you're saying that it can't be a covered outpatient drug just looking at the definition because the only one of those could possibly apply to it is in  and that's the relevant approval for all purposes notwithstanding the approval of a supplemental indication it is not a subsequently approved drug and that's why it's not within c today i'm sorry  provision in in part b through treatment of subsequently approved drugs talks about what do you do if you have a covered outpatient drug and is approved single source drug doesn't necessarily answer that question right yes i agree with that it's missteps and who wants to direct you to the definition of single source drug i'm very content to have the court look only at c to b and to see that c to be is directed to the approval of a drug not the approval of an indication because i think that's sufficient to resolve this case what was subsequently approved and for act are in two thousand and ten was a new indication it efficacy supplement it wasn't approval of the underlying drug itself and that's why we think c to be a sufficient we're not affirmatively relying on on case and that's that's misstepped since argument and i tried to explain why the produced  distributed requirement in k seven means even if you go down that path with her you're going to lead to it's going to lead to the same result but we are perfectly content for you to resolve this just on the face on th here and i want to be sure i understand your your position here it in my right it your position is that even if quests and twelve letter had been completely forthcoming and i'm not saying it wasn't us but assuming it incomplete were coming in even if the agency's c m s his response had reflected any of the confusion you think is in there you know which of those it happened near your position is that c m s can still recover all of these payments because the statute clear right clear statutory language trumps whatever the agency says that's your position right that that is my position but i do i do think that our our position is further strengthened by the fact that there was well you're changing  question i'm trying to get to the bottom of what your position is a clear statutory language trumps and i take your point that that you don't think they were forthcoming and i take your point that you think c m s letter was was a little cage itself or had limitations to it but just stick with my question which is if the statutory language is clear the agency's position has right doesn't make any difference what the agency told the regulat fair or the constitutional requirement ripe rather spare notice and here any fair notice was supplied by the plain text of the statute on top of and next to it and it makes no difference misled the agency told us we could do guess in your answer to that is makes no difference right so my my argument is you would it needs to meet the manifest injustice laid out in the quest case i'm not saying that no case might ever i think for the retroactive if you can bring it to me to example i'm curious we have to write an opinion here and if we write an opinion which says what you say we should say namely that claim clear statutory language trumps whatever the agency says that would be cited in future cases and i'm wondering what the limiting facts we have to apply principle to these facts in your principle is to repeat myself clear statutory language trumps agency misleading statements right that that's what i'm curious to explore with you and with me just give you a hypothetical ok so suppose congress in x where does have congress has one of its housing program provides voucher housing suppose suppose this is just a hypothetical suppose it says the voucher is cancelled if the resident runs a business  and it defines a business is a sale of any goods for money you get a hypothetical yes i do your are a resident comes to the agency says look we're having a pandemic i want to make so i can i think under the under supreme court case law that that's actually going to resolve that case but to the extent your honour's concerned with the breadth of the role i don't mind you that the relevant standard here is manifest injustice which i think is case of falls on the other side of the line if you're asking us to to to to write an opinion based on the principle i'd like you know on the principle you're offering do that work like my housing case the person the resident is a poor person who has a housing voucher unsophisticated  what where do you draw the line between qwest and that person where is it i have absolutely no idea and i have i don't know of any cases that help us to find that you see what i'm getting at here you're being very candid with me about your principle and i appreciate that that's very helpful to explain to what the agency's principle is your own for i just worry about us incorporating it in a binding opinion of the d not necessarily asking you to adopt a per se role here i i think it's appropriate to look to things like the two thousand and eleven letter in which questcor acknowledged and recognized that the n d a would not be used on a prospect of basis it was limited to settlement i think it would be appropriate for the court to look to the sophistication of mallinckrodt it would be appropriate to look at the fact that the court is and that this isn't the government going out and regulating parties in the market but rather is merely enforcing sta and contractual obligations against a voluntary participant in a government program who repeats significant revenues as a result of that participation and is not being asked of any penalty but is merely at being asked to repay the amounts that it took out of medicaid at was there any way for to regulate it entity to get a definitive ruling from a court in two thousand and twelve there wasn't was there i'm because  just find a way to see action they wouldn't be injured by anything so i don't see what standing they would have so you want us to adopt the rule where regulated then n t let's let's assume for the sake of my question that we find that everything that they did was above board and they go to the agency and they say look we're losing money by participating in this we don't think you want to stop out of this here's what's going on in the agency comes up with a solution and an interpretation of the statute they can't go to a court and get some sort of a declaratory judgment so they're completely at the mercy of the agency as to whether it's ever going to change its mind as to whether it it's going to interpret the statute but it's not like the low level bureaucrat gave them is is certainly reasonable to take into account but i do want to emphasize what mallon cry out or at the time quest court did not do and why you should be concerned that this is that this case is the one you're describing and there i  and i want to point out exactly what they didn't do but before i do that i want to make sure that the goalposts aren't shifted on us a little bit because missteps in this briefing emphasizes or pushes back on the idea that questcor was trying to ho k the agency and the hoodwink stander of the above board stander i think isn't the relevant standard here a quest for might have been operating entirely in good faith on the front end when they came to the agency and indeed they recognize the real deficiencies in this n d a theory they didn't even bother to propound it but because they were writing to a different theory they didn't put all the critical facts before the agency and in particular they didn't say what they told f d a in two thousand and eleven which is adopt but we have an alternative basis or way of getting there we can do this because the quote recently approved act our gel was approved under an n d a and is therefore different than the quote original product at that point there was a blinking red light and the onus was on questcor to come back to end the c m s and say wait a sec just so we're clear here here's what that two thousand and ten and v a number was and what it wasn't and particularly in a situation where the agency had said we're limiting our determination here to the facts that were before us and this is not a real piece of liability questcor got an answer they liked and they ran with it as opposed to fulfilling their obligation at a minimum to confer with the agency and make sure the agency was aware of all the relevant key piece of our argument as to why it's if you're going to say the statute doesn't provide adequate fair notice then i think you have to say at what point did questcor get fair submissions it had made to the agency if you're going to say the statute didn't provide the fair notice then it's just a question of was there enough of a blinking red light in that letter that the agency might have misapprehended the relevant facts that it was unreasonable for questcor for a letter twenty two a clearly and plainly deceptive mislead i would understand your point but you really can't say that about the letter sure it could have been more for an agency that also really really wanted to keep distributed the program and if the fact to ambiguous it's hard for me to see how the agency can consistent with principles of due process hypothetical was different i was actually surprised that missteps and conceded that if we found that the statute was clear that she would have no retroactivity argument maybe she did concede debt but it sounded like she might my question was even if we conclude that the statute is clear in in your favor we can also believe that you know reasonable lawyers or judges might disagree on that question i mean that's that's why they pay lawyers like missteps and big bucks because  you know the difference between chevron step one and step two is not readily apparent all the time to us or the regulated entities to agencies so i guess i'm i'm still not sure why it is that even if we alternately after wrestling with this believe that the statute clearly cuts in your favor that that necessarily means that it was unreasonable for regulated in a d to rely on the sorts of letter from the agency that so the opposite position if we think that you know it you know that close question in reasonable people might think that the statute is ambiguous on that point and that the agency was essentially interpretating the statute in a way that made sense for everybody at the time in maybe they change their mind later but this statute is unambiguous it would per supply the requisite fair notice in order for for us to prevail that being said i think you can also just get there by looking at things in total you don't have to sort of segment out of the different pieces of this one piece is the clarity of the statutory language but that act operates in tandem with the history here the fact that questcor was an ambiguously aware in two thousand and eleven that it had mistake theory of the district court i'm not quite sure about their characterization of this what we would say is c m s issued guidance on the facts that had been put before and was very upfront that what it was saying intent to or having done any outside research of having gone to track things down that missteps in the previous or directed to a world where the agency was on inquiry notice and sort of using that as the relevant standard and i just don't think that's the right way to i not i'd like to i don't when you talk know the information sure your honor so what we're dealing with here is the age of the quest came to c m s and said we'd like some guidance this wasn't an application according to a formal process that's laid out or governed by statutes or regulations they came to c m s and said we'd like some guidance on this here are some facts on those facts what do you think and the agency said we're not going out and doing this isn't a formal adjudication we haven't taken the responsibility on ourselves to fully investigate this we are saying you've asked for what our views would be on these facts on these facts it seems to us like you can reset your baystate andy not for the reason you think but one fact that you mention in your filing makes us think you probably can but it's our hope our advice here is limited to the facts you've given us and it's not a release of liability and questcor takes that they don't say oh wait a sec there is possible confusion here your guidance here might be might be incorrect and or you might not have considered this additional important information they just sort of want to because they like the answer they got based they left it out so is it your position that if in india a has been previously approved for drugs then it can never get a new base da a process is an entire new drug application for a for a chemical compound and recognizes it as a dispense not my hypothetical today i want you to answer my hypothetical plea my hypothetical assumes it's the same drug but a new indication was approved by the f d a in the f d a gave it a new n d a number for whatever reason in they said you can market it under that new in the a number your position is the same that there could be no change in the bay state a m p i am sorry to resist your hypothetical not quite sure how in the world that and i'm just not aware of any circumstance where that would occur i think there are situations where it is conceivable that f d a would accrue a new n d a for something that had was a previously recognized drug compound and recognized it as a new product and conceivably that and that new product was going to be administered prospect of late under a new and a number and that would would with the additional end indication that would be entitled to a separate baystate am p but if it's the same drug product with a new indication added i don't think there is a situation where it would be approved for just for marketing under or under the same  under the same n p a number so i but i think the relevant question under the statute my question is let's suppose even though you don't believe that that could happen if it happened you would say they still wouldn't get a new base date a m p because what the statute says doesn't change in the statute says it's going to be a drug approved new indication approved if all that was approved was a new indication  conceded what i conceded in response to judge tito's line of questioning is that when you have a statute that makes itself perfectly clear that the agency can only do x and the agency does the opposite of x does why if it is so perfectly clear that a regulated entity should never have reasonably relied on that statute on its face then you have the kind of blockage to my arguments that i was talking about what you were talking about judge wilkins i think is far more common which is that the statute can be interpreted to lead to a clear result but that different minds reasonable minds can disagree as they do here about what that clear result is judge will consider the question that you just ask to our argument judge dillard and this leads to a different question the judge table asked judge ttyl you suggested that one of the things that makes the statute clear is that the statute talks about the drug being produced or distributed under the  whole point is course you can use it for her and her seizures as it was produce to distribute it but you can't market it for that until the indication has been approved so it's and it only got orphan drug treatment for that marketing that the and here for the entire drug has been well i think for purposes of what the discussion we're having now which is whether x or was marketed at any point for any indication under the new n t a because of course the government's position is x are was never has never been marketed under the human d n a i think it is important that this received the orphan drug approval or do that it received marketing approval to market for that indication under the m d a for purposes of the bay state you know there are statutory consequences that flow from the m d a approval but on the marketing point just to round it off if i could remember that this is the issue that f d a squarely declined to irony of this really lands right because you have a company that didn't seek it many a it got one it didn't seek this interpretation it got it and what just what mr sultan is now saying is once that interpretation team over the transom an interpretation not from some underling as an opium versus richmond but an official interpretation that was given after instance of consultation and extensive letters with questcor that that  the regulated entity to say i want to make sure that you know all of the facts around it without judge hillard the regulated entity presumably having gone to its sister agency and said hey what's up with this new n t a this is for an old product there is something that will strike fear in the hearts of every single regulated entity in the country if it becomes incumbent on them to follow up with an agency just to make super sure that the agency hasn't made a terrible mistake if this isn't a terrible mistake that