Free Declaration in Support - District Court of California - California

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Exhibit M

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Threshold Pharmaceuticals Clinical Update On Th-070

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2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 [START HELLER-EHRMAN2NDCONFCALL.MP3] FEMALE VOICE: Good day and welcome to the

Threshold Pharmaceutical conference call to discuss the clinical update on TH-070. call is being recorded. This

At this time for

opening remarks and introductions, I would like to turn the call over Deni--, to Denise Powell. Please go ahead. DENISE T. POWELL: Good afternoon and Before we begin

welcome to the conference call.

and I turn the call over to Barry Selick, our chief off--, chief e--, executive officer. would like to make these forward-looking statements. Except for statements of historical I

fact, the statements in this, in this conference call are forward-looking statements, including statements regarding Threshold product candidates and clinical trial progress and results. These statements involve risks and

uncertainties that can cause actual results that differ materially from those in such forwardlooking statements. Potential risks and

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3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 uncertainties include, but are not limited to, Threshold's ability to complete its anticipated clinical trials, the time and expense required to conduct this clinical trial, issues arising in the regulatory process, and the results of such clinical trials, including product safety issues and efficacy results. Further

information regarding these and other risks is included under the heading Risk Factors in Threshold's Annual Report on form 10K, which was filed with the Securities and Exchange Commission on March 28, 2006, and is available from the SEC's website and on our website as well, under the heading Investors. We undertake

no duty to update any forward-looking statement made in this conference call. Barry?

DR. BARRY SELICK: Thanks Denise and thank you everyone for joining us on this call. purpose of this is a follow-up to the press release that, was just sent out literally five or ten minutes ago. As you all know, we've been The

investigating various doses and durations of treatment of TH-070 in our ongoing Phase II and Phase III BPH trials. We recently completed

dosing of all the patients in our U.S. Phase II

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4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 trial and 216 patients from that trial are being followed up. In our European and Canadian

Phase III study, however, we have observed three serious adverse events relating to liver toxicity, which has lead the FDA to impose a partial clinical hold on additional studies in the U.S. Given that our highest priority in the

conduct of all of our clinical trials is patient safety, we are taking the additional step of discontinuing patient dosing in our Phase III European and Canadian trial. We should note

that as of tomorrow, all 567 patients in that trial will have completed the first 28 days of dosing. Now obviously this is a disappointment

and given the human safety data previously published for this drug, a surprise. we have and will continue to compile a tremendous amount of data for greater than 800 patients for 28 days of dosing of TH-070 and are hopeful of being able to define a path forward that will reflect an appropriate balance of safety with efficacy for what we remain convinced will be an important therapy for this currently underserved disease. So with that as That said,

an intro, I am going to now ask our chief

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5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 medical officer, Alan Colowick, to describe in detail the three serious adverse events, as well as provide a summary of our discussions regarding this with the FDA. DR. ALAN COLOWICK: Alan? I'll

Thanks Barry.

describe the three SAEs in order and our two interactions with the FDA and then importantly, our plan moving forward. The first SAE was

reported in a patient in Europe who had a concomitant history of acute alcoholic intoxication and presented clinically jaundiced with a markedly elevated liver enzymes, as well as elevated bilirubin level. The patient had a

prolonged hospitalization and that was otherwise unremarkable and we're happy to report that that case has essentially resolved. We had a

discussion with the FDA about this specific case on April 10th, as well as the other data that we had available to us at that time across all of our studies. We discussed with them the plan

for the study for which this patient was enrolled, which was the European Phase III study, which is not filed to the IND and therefore not under their jurisdiction, but we wanted to discuss it with them at any rate. We

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6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 updated them on the progress of the Phase II U.S. study and I think it's notable to say that at that time, patients were still receiving active study drug on that study. The FDA felt

comfortable with our plan at that time, allowed us to continue the plan to clinical program, and move forward. Recently we learned of two

additional cases, which are somewhat different in nature, but still concerning from the European Phase III study. Again, after three

months of therapy, two separate patients had markedly liver enzymes, this time not associated with an increase in bilirubin. These patients

clinically at the time of their presentation did not appear to have any ill effects from the elevated liver enzymes and although both patients were subsequently hospitalized later, neither patient was hospitalized initially as a result of these elevations in liver enzymes. They were hospitalized later primarily as a cautionary measure. ongoing. These two cases are

We, they are not completely resolved;

however, at this time there doesn't appear to be any other clinical sequelae associated with the elevation in liver enzymes. We promptly

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7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 reported this, these two additional cases to the FDA and other regulatory agencies and had a call with the FDA where we discussed the additional cases, as well as the totality of the program. The FDA was aware that in the U.S. all

patients had completed dosing in the U.S. Phase II studies, so all 216 patients had completed their 28 days of therapy and that Threshold was no longer planning to conduct additional trials in the United States under the open IND. During

the call, the FDA expressed their concern about the liver toxicity and in a subsequent follow, follow-up call the same day, notified Threshold that we were being placed on partial clinical hold reiterating again that they understood that no patients were currently receiving active dose, except for a additional cohort on a clinical pharmacology study, which they agreed could continue, but this was done as a regulatory policy to prevent further clinical trials from being initiated until we resolved the partial clinical hold. We had a discussion

with them about what that meant. We have not received the formal letter from the FDA; however, we think we have a, a reasonable sense

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8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 of what those issues are and the issues are primarily related around, determining what is a safe, both dose and duration of the drug to move forward. We believe and, and I think FDA agrees that that plan would look something like a shorter duration certainly than has been use in the, current, European study and, would, we agreed that once we receive that letter, we would respond with a complete response to the partial clinical hold with, a data set that would include the data from the ongoing clinical programs, as well as completed, previous completed studies, both clinical and nonclinical. The plan moving forward now is to First

be very focused indeed, on the following. of all, we feel we've taken the appropriate steps to protect patient safety.

It was our

decision to, halt active dosing in the European Phase III study. We think that's the prudent

course of action currently; however, we're focused on, getting the data in-house from both the U.S. study, as well as the European study, where we'll have greater than 700 patients total who have received TH-070 for at least up to 28 days. We expect that we will hear from the FDA,

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9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 formally, with the letter of partial clinical hold and will promptly respond with a complete response to the clinical hold once we've got all of these data, adequately analyzed and interpreted. over to Barry. DR. SELICK: an update. Thanks Alan. That's basically With that, I will turn it back

What we would like to do is, open

the mike for questions, so why don't we go ahead. FEMALE VOICE: Thank you. The question and If

answer session will be held electronically.

you would like to ask a question, you may do so by pressing the star key, followed by the digit one on your touch-tone telephone. If you are

using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Once again, star one to

ask a question and we will pause for just a moment to give everyone an opportunity to signal. [pause] We will go first to Steve Harr with Morgan Stanley. MR. STEVE HARR: A couple of questions.

First off, could you review the liver tox data, from TH-070, in the oncology study.

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10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DR. COLOWICK: MR. HARR: Can I review that?

Yeah, just, just-[interposing] Sure. As you

DR. COLOWICK:

know, Steve, the data for us come primarily from data which is published in the literature. remind you that the drug was approved in, multiple European countries since 19--, since the mid 1980s for the cancer indication and in the literature are, are, approximately 80 published studies, around 20 of which are controlled clinical trials. In those controlled I'll

clinical trials, greater than, than 3500 patients are reported and in those studies, there, was, there was not any evidence of statistically significant differences in liver toxicity between those patients who received lonidamine versus those who did not. MR. HARR: correct? DR. COLOWICK: There are studies, in which But there are, there are trends,

numerically, in some studies the, liver toxicity, was, higher numerically, but certainly nothing unlike some of the other side effects, which clearly demonstrated a statistical significance. Nothing that came through in any

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11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 of the studies on that, in that regard. MR. HARR: Are there any of these patients

show, any manifestations of a functional deficit, in liver function? DR. COLOWICK: Are you, you talking about

the cancer patients or three SAEs? MR. HARR: The three SAEs. Yes. No--, none of them did,

DR. COLOWICK:

so markers of, is the liver able to perform its functions including things like glucose homeostasis, synthesis of proteins such as albumin, synthesis of clotting factors. In none of these patients were there any abnormalities in any of those types of assessments. MR. HARR: And what were the, the other, the There

other patients who had, who had issues? are three other patients? DR. COLOWICK: Yeah, we have three

additional, patients who we simply only have lab data for primarily at this time who, come from other studies, were not reported as SAEs, but we felt that we should, should discuss those patients, with the FDA and notify them about those patients. Those are patients for whom as

we bring the data in house and get the clinical

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12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 database now, from those patients, we'll know a lot more about them in the future, but clearly not nearly the same degree of elevation of liver enzymes that we observed in the patients who were reported as SAEs. MR. HARR: And were these SAEs in patients,

uh, on 50 or 150 mg of drug? DR. COLOWICK: at both doses. MR. HARR: data? DR. COLOWICK: Well, we expect now to, as, And, when will we have efficacy The three SAEs occurred at,

as we mentioned, all patients in the U.S. study have completed their day 28 dosing and in Europe now at this time actually tomorrow, all patients there will have completed their day 28 dosing, so if what you mean by efficacy data are the data from, from these ongoing studies, we will get those in house as quickly as we can and get them analyzed. We clearly expect that that will

occur during the third quarter. MR. HARR: Great. Thank you. I'll jump

back in the queue. DR. COLOWICK: FEMALE VOICE: Yeah, thanks. And we'll go next to Terrence

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13 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Flynn with Lazard. MR. TERRENCE FLYNN: the question. Hi. Thanks for taking If

Just had a quick question.

you could review the timeline again as to your interactions with the FDA. I know the first one

occurred in April, but the second one I, I think I might've missed it. DR. COLOWICK: Yeah, I didn't state

specifically Terrence, but we had that, we had the, a, a couple of calls with the FDA yesterday; afternoon was the last call with the FDA. MR. FLYNN: Okay, great. Mm-hm. And we'll go next to Mike Thanks a lot.

DR. COLOWICK: FEMALE VOICE:

King with Rodman & Renshaw. MR. MICHAEL KING: Thanks for taking the

question. Just sort of following up, on the previous questions. I'm just wondering, Alan,

do we have a complete medical history of all of these patients. Do we know what other, drugs they were on? Do we know anything about, you

know, their underlying health and whether there were any, confounding factors? DR. COLOWICK: Yeah, we, we're in the

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14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 process of, of getting all. Of those data of

course of the patients with SAEs, we have a fair amount of data from their past medical history, as well as additional diagnostic tests, which we've have undertaken. By in large, I think the

most notable event is in the first patient who clearly had an, a history of recent increased alcohol consumption and quite frankly, clinically behaved differently than the other two patients with SAEs, for whom ac--, acute alcohol intoxication does not appear at least to be, to, to be, a factor. These patients, just

generally what I can tell you is that, they, they obviously were healthy enough to meet our inclusion/exclusion criteria, did not have any, were not on any medications that would, we would have predicted would predispose them to liver toxicity, nor comorbid medical conditions. We've undertaken a series of tests and have, various amounts of data on each of these patients with regard to their status for infectious hepatitis, as well as, imaging, both by ultrasound and in some cases CT scans of the gallbladder, and the, and the liver. There were no findings from that other than in the first

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15 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 patient again. The patient had, was able to

have, gallstones visualized by ultrasound, but there wasn't dilatation of the bile duct suggesting that there was an obstructive posthepatic component to this enzyme elevation. Early data, suggests that some of these patients, while not having acute hepatitis A, certainly have had previous exposure to hepatitis A and that's something that I think we need to follow up on. And then finally, we are

in the process of evaluating the drug products, which was used in these studies to rule out any, any sort of instability or metabolites in the drug product, which may have been associated with this, but we don't have those data on any of these patients yet. MR. KING: Okay, and if I might, just two, Number, number one: can

two, quick follow-ups.

you tell us just, I mean, what criteria were you using to, quantify these as SAEs? Was it five

times upper limit of normal, ten times upper limit of normal? DR. COLOWICK: Yeah. Actually, our, our

cri--, we didn't specify because we weren't expecting liver toxicity. Quite frankly, we

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16 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 didn't specify, pre-specify a level of liver toxicity which would a priori cause, a--, an event to be specified as an SAE. This was

something that was in the judgment of the investigator. For all three of the patients at

some point now during their course, they've been hospitalized, which automatically, qualifies them as having an SAE. I think the magnitude of

the elevation of the liver enzymes, even in the absence of significant clinical symptoms were concerning enough to the investigators that they classified these as SAEs and we, quite frankly, were in agreement with that. MR. KING: Ca--, but can you tell us what,

you know, what the measurements were, or, or "-"-DR. COLOWICK: [interposing] No, yeah, I'm, It was

I'm happy to do that in the three SAEs. a range.

Obviously the patient who, presented

with the, concomitant elevation in bilirubin; the, the first patient, had an elevation in their transaminases of approximately, 20 to 30x at their peak and an elevation in their total bilirubin of about 20x at its peak, all of which have normalized now. The two--

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17 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. KING: [interposing] Sorry, bil--,

bilirubin was what? DR. COLOWICK: About a 20x increase over

upper limits of normal. MR. KING: [interposing] 20x? Okay.

DR. COLOWICK:

The two patients with

isolated transaminase elevations are more in the range of, 10x or so, roughly 10x, which in those cases for, for what it's worth, uh, the ALT is elevated disproportionately to the AST, which was not the case in, in the first patient that I described to you that had the alcohol intoxication. MR. KING: That ratio was, was reversed. Okay, thank you. That's helpful.

And then finally, Alan, you mentioned, the 80 controlled trials in a cancer setting, I'm sorry, 20 controlled out of 80--of which-DR. COLOWICK: MR. KING: [interposing] Right.

What, up to what doses were used

in, in those trials? DR. COLOWICK: that Mike. Yeah, I, I'm glad you asked I'll

I should have mentioned it.

remind everyone that in the cancer setting, the doses are roughly 3 to 6 times higher than the doses used in the, BPH trials, highest dose used

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18 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 in the BPH trials. So the doses that were

used in most of those trials ranged from 450 to 900 mg per day, where the highest dose that we're using in the BPH study is 150 mg and importantly, in many of those studies we have patients, they report patients who are on the drug for many months to even years. So to say

that this was surprising to us to see these results I think based on from what we understood from the published data at least, is an understatement. Clearly at much higher doses

and for longer periods of times, these kinds of findings, while anecdotally potentially reported, certainly there was no pattern in the literature that would have suggested that this is what we would have seen. MR. KING: Okay. Thank you.

DR. COLOWICK: FEMALE VOICE:

Yes. I'm gonna to take our next

question from Brett Holley with CIBC World Markets. DR. BRETT HOLLEY: Yeah, my question concerns when you actually saw the elevations in the course of treatment, unless the three patients in the European trial; was it, was it early in

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19 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 treatment? You know, just temporally, where,

where it was detected? DR. COLOWICK: Yeah. All patients were

detected at their last visit on study drug, which was after 12 weeks or 84 days of dosing. It's notable that all patients after 28 days of dosing had normal enzymes, both their transaminases and their total bilirubin. time these patients were on that study, we weren't looking at liver enzymes in, in between that first month and third month of therapy. We've since added after the first case was reported we've, we've added now a, a month two, assay, but for these three patients, I don't know exactly when the onset was. We just know At the

that it certainly occurred after their 28 days of dosing. DR. HOLLEY: So at 28 days, all three of

those patients were entirely normal. DR. COLOWICK: DR. HOLLEY: Entirely normal. Is there any, I guess

mechanistic or PK explanation that you could come up for the difference between the, the 28day and the 12-week difference? DR. COLOWICK: Yeah,it's a, a great question

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20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 and obviously one we're working hard to try to understand. There's nothing, there's nothing I will,

that satisfies us as an explanation.

I'll remind you that the drug is, has a fairly simple metabolism. It's glucoronidated and then There are, there are

excreted by the kidney.

enzymes, glucuronidation enzymes and some differences amongst individuals. With respect

to some of those enzymes, we have some of the data we don't have back yet is looking at these UGT 1A1 enzymes just to characterize that the gene level these patients--which we'll do across all the patients in the study now--to see if there's some pattern, but other than that, there's really nothing from a PK or mechanistic perspective that, that, that we think is a satisfactory explanation at this time. DR. HOLLEY: And I guess one final question.

Is there any difference in the manufacturing between the, I mean the drug that was used in the European trial versus the drug that was used really in the oncology setting? DR. COLOWICK: DR. HOLLEY: Well-[interposing] Has there been

any changes in the manufacturing that could

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21 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 account perhaps for a contaminant? DR. COLOWICK: Well, there, it's, it's the

same API, but the finishing of the product that we've used for our clinical trial material was different than the finishing, different, firm, did the finishing of the product. And so it's one of the things that we're very, obviously, anxious to understand and we've, we're in the process of retrieving the, medication from the patients in these sites and will be doing the analysis. Obviously, before we released the material from this finisher, in terms of the tests that are necessary to release clinical trial materials, the, the drug product met all of those specs that, that we would have had in place, but that doesn't preclude the possibility that something could've happened anywhere up until the time that the patient took the drug and that's something that, we clearly, are very focused on trying to understand. DR. HOLLEY: DR. COLOWICK: FEMALE VOICE: Thanks. Mm-hm. And we'll go next to John

Wilson with Robert W. Baird & Company. MR. JOHN WILSON: Yeah, hi. Thanks for

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22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 taking the question. Actually, most of my

questions were already answered, but I was just wondering if you could any way, in any way provide clarity on the timeline for your response to the FDA? DR. COLOWICK: Yeah, John, uh, I think what

I can tell you is obviously, we're going to, to put in as rapid and quality a response to this, to this notification as we can. First of all, We

we have to receive the formal notification.

were informed yesterday afternoon by a telephone call. The FDA has up to 30 days to send that letter, although I think, our reviewers in this division, are trying to cooperate and get that to us sooner. We expect it could come sooner.

Until we have that letter, there, there's a formal response with this required. It's called

a complete response to the partial clinical hold and until we have that letter, we can't say with certainty what it will take to address their concerns. I think we have a very good feeling

of what it will take based on our conversation yesterday, but until we see it in writing, we can't say with certainty. I can tell you that we are going to do everything we can to get the

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23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 clinical data, that is the data in these roughly 800 patients from the European and U.S. Phase 2 studies and in particular, the day-28 data from these patients. We'll do everything

we can to get that in-house just as rapidly as we possibly can and then it'll be a matter of analyzing those data. We've got some important

completed studies, preclinical tox studies that the FDA, is just becoming aware of because

they've just recently been completed and we'll have to tie those two things together, and so that may take some time, although obviously it'll be our number one priority in the company. MR. WILSON: DR. COLOWICK: FEMALE VOICE: Okay, thanks. Mm-hm. And once again to ask a

question, it is star one on your touch-tone telephone and we'll go next to Joshua Schimmer with Cowen. MR. JOSHUA SCHIMMER: my questions. Hi, thanks for taking

First, did any of the patients

with the liver enzyme a--, abnormalities have liver biopsies? If so, what did they show? Yes, Josh, no--, none of

DR. COLOWICK:

these patients have had a biopsy, given that,

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24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the clinical course has been, something which didn't look to be progressive. The patients,

clinically looked, looked stable and particularly in the first case where the case had completely resolved, it wasn't felt that the, risk of a liver biopsy, was, was worth it by the clinicians taking care of the patient. MR. SCHIMMER: this. Okay and I may have missed

Um, are you able to or were you able to

measure the TH-070 levels in the patients, a--, at the time that they were found to have the elevated liver enzymes? DR. COLOWICK: Yeah, un--, unfortunately, we

were not able to--without getting into all the details--it's actually technically not an, an easy thing to do in terms of the, the sampling and the handling of the sample. We are gearing up to try to get more patients coming off study drug, at, at this point in time; those levels, but in these three specific patients it was not possible. MR. SCHIMMER: Okay and then have all,

patients in all studies now had follow-up liver enzyme tests to make sure that there were no other asymptomatic patients with this problem?

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25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DR. COLOWICK: Well, all, all, all

patients are monitored on a regular basis in the study, so depending on where they are in the study, they're monitored after one month, two months, three months in the European study and after one month of dosing in the U.S. study, as well as after the three-month blinded followup. So up until now all patients--and we review these data on a weekly basis in a blinded fashion, up until now obviously all those patients have had their scheduled visits. now will be in the process of, bringing the patients in the European study in for, their last study visit on study drug and they'll be monitored for liver enzymes at that visit as well. MR. SCHIMMER: Okay. for my questions. DR. COLOWICK: FEMALE VOICE: I'm, I think that's it We

Thanks. Okay. And we'll go next with a

followup from Mike King with Rodman & Renshaw. MR. KING: Thanks for taking the followup.

Gentleman, can we get a, an update on the other, trials? When, when would we, expect, reporting

on, glufos and 2DG?

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26 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DR. COLOWICK: Sure. So, Mike, no change

in the guidance there.

We think we're just on

track to have data from the glufosfamide Phase III study second-line pancreatic cancer patients by the end of this year. At that time, we

expect also to be able to report some top-line response data from the Phase I, or from the Phase II study and front-line therapy combination glufosfamide plus gemcitabine and also we expect in the coming months to announce the initiation of additional studies and other tumor types of glufosfamide. In terms of 2-

deoxyglucose, we expect also by the end of the fourth quarter to be able to report results from the Phase I,--[coughing] excuse me--the Phase 1 study of 2-deoxyglucose and to determine a dose to carry forward in Phase II studies, as well as potentially the initiation of some investigatorinitiated study. MR. KING: Thank you. And that is all the questions

FEMALE VOICE: we have.

I'll turn it back over to Dr. Selick,

for any closing or additional remarks. DR. SELICK: Okay, well again, thanks, all Obviously, we're

of you for your questions.

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27 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 intently focused on trying to get to the bottom of these events. We will be available for the next several hours, obviously, as well as tomorrow, starting relatively early, so to the extent that you might have any follow-up questions or want to discuss this further, don't hesitate to give us a call. If you don't have

Denise Powell's phone number, in front of you, it is (605) 474-8206 and Denise will ensure that you get to whoever it is that you would like to speak with. So again, thank you very much. This does conclude today's You may disconnect at this

FEMALE VOICE: conference call. time.

Thank you for participating. [END HELLER-EHRMAN2NDCONFCALL.MP3]

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28 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Signature Date Melanie Culley C E R T I F I C A T E The prior proceedings were transcribed from audio files and have been transcribed to the best of my ability.

February 3, 2008

Case 4:07-cv-04972-CW

Document 20-14

Filed 03/07/2008

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