and then out at the f d a approved the trial for treatment of five patients they also chose to announce a timeline for conducting a study of the trial and then in may just a month later the company issue warrants that were raised sixteen million dollars for the company at the here because it had no weapon you would have no other products and you're spending money millions of dollars a quarter just a couple of months later in august they issued another press release regarding the f d a action and they disclosed for the first time that the f d a approval was conditional that they had to stagger the trial and go one patient at a time following that patient before applying for permission to go in next patient they changed the timeline of the study saying we're not going to start it a couple of months it two thousand and thirteen but they didn't expect to all of the five patients the new timeline that was announced in august cause a dramatic forty percent in the company start the day of the announcement additional drop in the following day the indicate that the company knew in april what it knew in august in the f d a letter is exactly such a talking they chose to issue the rosiest statement words out of the letter yeah the word approved appears in the f d a letter without question yeah but it said approval with conditions africa conditions now morning conditions and the f d a letter says the study will look five patients over fifteen clearly stated two different places that you need to redesign the study if this study will support your next stage that and if you don't press release talked about and we complete the study we you need to redesign this study if it's going to support a future application for a future study the f d a clearly said and they will argue this i'm sure that you can commence a study now if you wa this is from april to december after having said we're going to start this study it or two thousand and thirteen thirty july whatever gave this post the statement that we have approval  creating that team one timeline out of whole cloth they were simply reflecting the timeline that the f d a itself had set forth in the approval letters and not so your argument but the f d a didn't seem to allow for it they're the ones that in their letter that use the fifteen fifteen month period and they talk about you know we're going to stage it in you you study one for three months and issue is this the to redesign the study i think that's a longer period of time and when when you think about materiality of the rotor standard of a case that you owe it to disclose material facts seems to be carefully crafted to avoid some of the legal issues if you see the we expect the study begin the certain point we intend to signal that it had a certain point so there is a there is some inherent contingency in in that language which arguably should put a potential investor on notice that there is there's nothing for proof about all the see don't the get some i took to what is your saying you know what if something that's already occurred that's fraud or into something that happened in the future that's a cautionary statement you don't want something that's already occurred they chose to reasonable timeline can we rely on it when you were do you see the timeline as beginning according to the april press release that they would start the study they were to finalize details and start vivo a couple quick responses to mr shapiro you tried to expand the record today by telling the court that the study still going on in two thousand and sixteen i guess you know what that tell the court that it didn't take fifteen or eighteen months to enroll these five patients it eleven months to enroll them so it's not even fraud by hindsight this tiny issue that that he's trying to revise the court of so because he feels free to expand the record contrary to what you feel also i just want to clarify what actually it somewhere in the letter if that's what the f d a says and the f d a said that and worse the juster and said we merely parroted it but in fact we gave ourselves eighteen months not fifteen months to complete their moment of the study so if there were some issue with regard to how long it would take to go from patient want patient to a patient three division for division five we incorporated that into our timeline certainly did the best we could under the circumstances at that time so it's very hard to say that looking at that letter and looking what we said there was somehow something false something that wasn't warned about or something that that was false in any way that there was with side enter i would i would certainly say that well unless unless unless you knew at the time that he redesign was going to be required it was going to take past into the month of october at least before that redesign was i understood you money but there's nothing like that in this record and mr shapiro doesn't really argue that in fact what all he says is i thought what he was arguing was that when the f d a says you need to do x and x is actually going to be required for you to ever get it to market that that's enough he does say that your honor but i think that argument misses the mark by a very wide margin because first of all the letter while he says the letter erected a barrier to begin the study the letter says you may enroll one patient at this time and it does not say if you want mr shapiro must the same five times it says you can roll the patient if you want it doesn't say that he's making it sound like the letter says you can do so now but you do so in your own and we said mid two thousand thirteen i think it was so we gave ourselves a few months to start a study that the f t c said we could study that day and said here are some things you need to do in the next forty five days and he makes it sound like the study to say prescription i mean some of these things could have been done more quickly than it took me to describe them just now and he saying we had to redesign the study we did not have to redesign stuff that is that is not what happened and he also says well the f b i can't require you to do one thing the f d a can most certainly do something which is say you can't start the study of course they can't make us do whatever it is they want us to do but they can tell us don't start the study now don't do it this is a very significant thing we're putting a device in the spine of somebody who suffers from paralysis after some traumatic of that like a motorcycle accident they're going to have us waste our time and their time and they injure people you radically if the study is a complete waste of time but instead they send a letter that says you can start it now and mr shapiro is basis for science or is this letter that's all he has and he has it because we did a thing and we gave it to him in the context of this case he did have this letter we filed in case we put it in our motion to dismiss and we put it in to show the court that the language in the first letter he straight from the f d a and it's pretty hard to say that we acted with s solely on the basis of a ladder that a federal judge read in the context of our press releases and said our press releases are not false or misleading even if this court were to disagree with that notion somehow which of course we defend vigorously and believe the press releases are not false not misleading or completely accurate but even if this court were to disagree imagine a situation where this or were to say that this letter not only shows that the press releases were false but they were they were made this court last year says exactly that you have to knowingly say something that's false or misleading pretty hard to say we knowingly said something that's false or misleading when a federal judge has looked at it and said it isn't false or misleading how could we have knowingly done so were those conditions relevant because the f d a was saying yes you can begin your study now but to the extent that you contemplate as many as five subjects before you can move on to the second subject you have to comply with with these conditions in other words one of those conditions very important terms of your ability to go beyond the one subject that could be could be that you study is part of the beginning of the investigation understood you want to there are two separate sets of conditions i think the sector talking about is the set that says you can start out but in the next forty five days you need to do this there's no argument that we weren't able to do that in forty five days obviously that the f thought we could do it within forty five days they're not in the business of placing impossible deadlines on us you know start the study out and do this in forty five days but of course that's one reason we know him so there's nothing in the record that that the we anticipated doing what we intended to do what we said we hope expected to do and what the f d a laid out for a timeline for us to do with it so the f d a is pretty knowledgeable about this and the f d a sent us a letter setting forth this in forty five days you can start now it will be five subjects three months each a total of fifteen months and we give ourselves three months to start the study we have a thirteen months to complete asked about i think it's quite important here because to the extent mr shapiro is relying on these statements about the timing he's very focused on you could've done this in this amount of time you could've done that in that amount of time those are of our control regulatory agencies may require us to the late clinical trials of various grounds that's a pretty specific warning about what might happen here and investors understand this is a very early stage company this has never been done before this is never been implanted into a human being before and there may be delays and we warn about those the days this isn't mr shapiro would say you know because he said it that i know this is different the risk had already come to pass and you didn't tell anyone about the risk that's not true the f d a said you can start the study now you can start it now what are we supposed to warn about there with the f d a told us we could start it now of course there could be delays in what we were doing and we warned about that but we gave ourselves three months to start the study we gave ourselves eighteen months to go through these five patients and we warn that of course that might not happen and in august we issue another press release which apparently has no problem with the august press release that i was press release  says we're going to start the study later than anticipated that also turned out to be a little bit overly optimistic but no one's accusing our new c e o or c e o at the time i pastor of committing fraud when he gave an estimate about when he thought the study would start and he turned out to be wrong why because you can't know something in the future you can only state what your intention is and it was it was a pretty fair statement of what our intention was at that