Jay Carlson Steven W. King - Chief Executive Officer, President, Director, Chief Executive Officer of Avid Bioservices Inc and President of Avid Bioservices Inc Joseph S.

Shan - Vice President of Clinical & Regulatory Affairs Robert Garnick - Head of Regulatory Affairs Paul J. Lytle - Chief Financial Officer, Principal Accounting Officer, Corporate Secretary, Chief Financial Officer of Avid Bioservices Inc and Corporate Secretary of Avid Bioservices Inc

Joseph Pantginis - Roth Capital Partners, LLC, Research Division Charles C. Duncan - Piper Jaffray Companies, Research Division George B.

Zavoico - MLV & Co LLC, Research Division

Thanks, Jamie. Good afternoon, and thank you for joining us.

On today's call, we have Steve King, President and Chief Executive Officer; Paul Lytle, Chief Financial Officer; Joe Shan, Vice President of Clinical and Regulatory Affairs; and Rob Garnick; Head of Regulatory Affairs. Steve will begin by providing a brief overview of the company's progress over the last quarter, including the company-sponsored trials, as well as the investigator-sponsored trials or ISTs, and how these events set the stage for numerous near-term clinical data milestones.

Joe will then review the clinical developments of the quarter, with Rob then discussing our regulatory plans as we advance our bavituximab and Cotara programs. Paul will then finish with a summary of our financial results for the third quarter fiscal year 2013.

After our prepared remarks, we welcome your questions. Before we begin, we would like to remind you that during this call, we will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ.

These forward-looking statements reflect our current views about future events and financial performance and are identified by the use of terms and phrases such as believe, expect, plan, anticipate, on target and similar expressions identifying forward-looking statements. These risks include, but are not limited to, the risk factors detailed from time to time in our filings with the Securities and Exchange Commission, including, but not limited to, the annual report on Form 10-K for our fiscal year 2012 ended April 30, 2012, and quarterly report on Form 10-Q for the third quarter ended January 31, 2013.

Investors should not rely on forward-looking statements because they are subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. And we expressly do not undertake any duty to update forward-looking statements whether as a result of new information, future events or otherwise.

I will now turn the call over to Steve.

Thanks, Jay, and thanks to all of you for participating in today's quarterly call. Since last quarterly conference call, we've made significant advancements in our drug development programs and have seen continued solid performance from our manufacturing business as part of our hybrid business model.

We have successfully executed toward our stated goals for advancing our lead clinical programs, bavituximab and Cotara, and have already surpassed last year's manufacturing revenue total with still one quarter to go before fiscal year end. Perhaps at the forefront of these advancements was completing and announcing the results of our internal review of data from our Phase II clinical trial of bavituximab in second-line non-small cell lung cancer.

The review was prompted by the discovery of bio-coding discrepancies in 2 arms of the study and was very comprehensive. It involved testing thousands of product vials, patient samples and a thorough review of data from the study.

Results from the review did not indicate any evidence of discrepancies in coding assignments at the high dose or 3-milligram per kilogram bavituximab arm of the trial. While there was ample evidence of coding discrepancies between the placebo and the low dose or 1-milligram per kilogram bavituximab arm.

Based on the thorough review, we chose to move forward with the conservative, and in the end, the least subjective approach to the updating of the data from the trial, combining the 1-milligram per kilogram and placebo arms into a single control arm and comparing those results with the 3-milligram per kilogram arm of the study. As Joe will discuss in a moment, the data from this updated analysis shows a compelling improvement in median overall survival for patients receiving 3 milligram per kilogram bavituximab and we are confident that the overall data from the trial provides a strong rationale for advancing this dose combination in the later-stage clinical development.

Rob will provide additional insight during his upcoming section. We also continued to make progress in the rest of our bavituximab clinical program.

In addition to the second-line non-small cell lung cancer data, during the quarter we also announced encouraging data from our randomized Phase II front-line pancreatic cancer study. Joe will cover the data in greater detail, but I can tell you that we are encouraged by the early signs of activity we saw in this very sick patient population with advanced disease, and that we look forward to presenting additional data from the study in an upcoming medical conference and to working closely with our clinical advisors to establish the next step toward advancing the program.

In addition, we and our clinical collaborators are continuing the study of bavituximab in different indications and combinations, and we look forward to presenting data from these studies as it becomes available. We are also continuing our clinical evaluation of our PS-targeted imaging agent, PGN650, in solid tumors and look forward to providing results from the study at an appropriate time point.

Our partnering goals for bavituximab program have not changed. We are pursuing, in parallel with our development efforts, potential partnerships for the program as we look to move into later-stage clinical studies.

This quarter also saw the continued advancement of our Cotara program following the successful discussions with the FDA on a Phase III trial design announced in December. We are continuing our plans for moving the program toward a pivotal trial in patients with recurrent GBM while we move in parallel with partnering discussions of the program.

On the manufacturing front, Avid continues to have an outstanding year, with record revenues in sight. As Paul will outline at the end of the call, Avid is an instrumental part to keeping our burn rate in check, as well as providing a key strategic role for our internal clinical development programs and possible future commercial manufacturing needs.

As we look forward, in the coming months, we anticipate meeting with the FDA in the second quarter of the year to discuss our plans for moving bavituximab toward Phase III development in second-line non-small cell lung cancer; presenting additional data from both our second-line non-small cell lung cancer clinical trial, as well as our front-line pancreatic cancer study; median overall survival data from the randomized Phase II bavituximab study in front-line non-small cell lung cancer; presentation of data from ongoing ISTs, as well as the imaging clinical program; and continued stellar performance at Avid Bioservices. I will now turn the call over to Joe, who will review in greater detail recent clinical developments.

Joe?

Thanks, Steve. The clinical activities during the quarter were highlighted by data readouts from 2 of our 3 company-sponsored Phase II clinical trials.

Beginning with our randomized double-blind placebo-controlled trial of bavituximab in second-line non-small cell lung cancer, let me remind you that the updated efficacy analysis now compares the 3-milligram per kilogram bavituximab arm to a control arm comprising the pooled data from the placebo and the 1-milligram per kilogram bavituximab arms. This analysis resulted in a median overall survival estimate of 11.7 months in the 3-milligram per kilogram bavituximab arm, compared to 7.3 months in the control arm, representing a meaningful 60% improvement.

Bavituximab was also well tolerated with no significant differences in the adverse event profile across the trial arms. We plan to report additional data from this trial, including updated subgroup analyses and safety data at an upcoming medical conference.

In the meantime, these data are compelling and allow us to move with confidence into discussions regarding a Phase III trial design, which Rob will talk about shortly. The second trial to read out during the quarter is our open-label randomized trial with bavituximab in combination with gemcitabine in 70 patients with previously untreated Stage IV pancreatic cancer.

The Phase II trial was our first in pancreatic cancer and was designed to cast a wide net. Eligibility criteria were relatively broad, allowing enrollment of adults with no upper age limit, inclusion of distant metastases and ECOG performance status of 0 through 2.

The combination of bavituximab and gemcitabine resulted in more than a doubling of overall response rate of 28% versus 13%, an encouraging sign of anti-tumor activity. In addition, a modest improvement in median overall survival was observed, 5.6 months versus 5.2 months, despite enrollment of older patients with poor performance status and rapid disease progression as evidenced by the short survival time in the control arm.

Further analysis including subgroups are underway, which we plan to present at a future medical conference. Meanwhile, we are encouraged by the trial results to date and are evaluating next steps for how best to advance the pancreatic program in order to take advantage of bavituximab's immunologic mechanism of action, but are looking to define a patient population that would allow a potentially longer dosing duration.

In addition, we are considering strategies which factored in the recent development in the treatment of pancreatic cancer. We look forward to sharing these plans with you when finalized.

I'll now turn the call over to Rob, who will review our regulatory strategy for the late-stage development of bavituximab.

Thank you, Joe. The Clinical and Regulatory Affairs group has had a really busy quarter, and as you have heard, the next quarter will certainly be no different.

With respect to our lead indication, bavituximab, in second-line non-small cell lung cancer, we are in the midst of planning for a meeting with the FDA some time during the second quarter of this year to discuss the size and design of our proposed Phase III trial. What I can tell you is given the reanalysis of the Phase II data that both Steve and Joe have alluded to, we anticipate that this trial will be in the 600-patient range and could involve an interim analysis.

Our goal is to initiate a Phase III trial by the end of the year. I would like to point out that our bavituximab Phase II trial accomplished what it was designed to do, in that it achieved a determination of the intended dose for Phase III, expanded our understanding of the favorable safety profile of bavituximab and produced a clear signal of clinical efficacy.

Having accomplished these 3 critical things, we feel confident in moving the bavituximab 3-milligram per kilogram dose into Phase III, that this dose has a favorable safety profile and has demonstrated promising signs of clinical activity. With this data in hand, we feel that we have a strong package of information ready for discussion with the FDA and are confident that this program should move forward into late-stage development.

I'll now turn the call over to Paul.

Thanks, Rob. Shifting gears now, I'd like to spend the next few moments covering a few financial highlights and our related financial goals.

As I mentioned on the last call, it's important to note that we operate a hybrid business model that includes a revenue-generating contract manufacturing business and an advancing drug development business. Let me first focus on the revenue-generating business, Avid Bioservices.

During the recent quarter, Avid generated $7 million in contract manufacturing revenue and $17.2 million for the recent 9-month period. This represents a 34% increase in revenue over the prior year 9-month period and so far, exceeds the total contract manufacturing revenue reported during the entire fiscal year 2012.

And as a result of the mutual successes of both Avid and its customers, we are raising our revenue guidance from $18 million for the entire fiscal year 2013 to at least $20 million, representing potential revenue growth of over 35% compared to last fiscal year. In addition to revenue growth, it's important to note that we have a backlog for future services that currently extends through fiscal year 2014.

As of January 31, 2013, Avid had customer commitments in excess of $25 million, covering services to be delivered during the remaining quarter of fiscal year 2013 and into fiscal year 2014. Let me turn to our net loss.

Strong revenue growth combined with an expected decrease in R&D spending have significantly reduced our net loss for the current quarter and current 9-month period. Our net loss this quarter has decreased 56% to $4.9 million.

And for the recent 9-month period, we saw a 32% decrease in our net loss to $21.3 million. In addition, this reduction in our net loss has translated into a 64% reduction in our cash burn rate during the recent quarter to $3.6 million, representing a reported net loss minus noncash expenses.

Let me now talk about our financing goals. As a backdrop, let me emphasize that we are closely managing our business, our cash position and our various sources of capital as we prioritize and advance our later-stage clinical pipeline.

Investing in our clinical programs is the most important and significant potential value driver for Peregrine. Over the past several years, we have invested in these programs using a balanced financial approach.

We have closely matched our capital needs with our various sources of capital, and we always seek nondilutive capital as a preferred source of capital, such as manufacturing revenue, to reduce our overall reliance on the capital markets. Looking ahead, we will continue to closely manage our operations in line with our cash position while balancing our various sources of capital.

We look forward to keeping you updated on our progress. And we will now open the call up for your questions.

Operator?

A couple of questions, if you don't mind. You've obviously come a long way with regard to answering the questions in the second-line lung study.

And now, as you'd mentioned, you're preparing for the phase -- end-of-Phase II meeting and talk about the pivotal study with the FDA. Now maybe can you provide a little additional color as to how you're preparing for this meeting?

Obviously, you might be talking to some FDA consultants or what have you, and I guess the ultimate question as part of this discussion is what's really giving you the true comfort after all your analyses from the study and the discrepancies in the study, that you can -- the comfort that you can really get back to your original plan to move this into Phase III? Then I have a follow-up.

Sure. I can take a quick stab at that, then I'll turn it over to Rob to fill in some of the details, but I mean, I think that this is obviously a very expansive process of going through and reviewing the data from the trial and making sure that we understood it as well as we possibly could.

And I think that, that really forms now the basis of how we view our clinical experience of bavituximab, achieving our goals in the Phase II study by identifying a dose we're comfortable moving forward with at 3 milligrams per kilogram and then also further establishing a safety profile. And again, it's not just from this second-line study, but it's the total experience.

So clearly, we've treated patients in a lot of different studies and now built a very nice safety database for the program. So I think overall, that's what gives us the confidence moving into the -- before actually advancing the program into Phase III to begin with, and basically, I think also, one of the reasons that we undertook the relatively conservative analysis approach that we did for the second-line data was that it would allow us then to really have a, what we think is a good way to estimate the size of the Phase III clinical study.

And so I think because we've taken a conservative approach, we feel like, if anything, we're at a disadvantage, from the numbers standpoint, and if anything, should be in the end probably overpowering the study. But we certainly want to take a conservative approach given the nature of what we had to review and the analysis that had to take place.

So I think that's what's given us the confidence moving into that -- into the discussion with the FDA and beyond that, of course, into starting the study. Rob, I'll turn over to you as far as kind of the preparations and what the group is doing.

Thank you, Steve. And we have quite a whole plethora of regulatory things that we're dealing with right now to get ready for the end-of-Phase II meeting with FDA.

And that meeting, as you know, really encompasses all of the information we have on the drug. We're tying up all the bows right now on the Chemistry, Manufacturing, Controls section of the IND and actually make -- ready to make a submission to FDA shortly to cover that section of Phase II, of which there is no surprises and which has gone extremely well.

So we can certainly make the material. We can make it reliably.

We can make it at an economical level. And then, of course, we have to deal with all the issues on the clinical side.

And as Steve said, the 3 things you really need to know for going -- for end of Phase III with FDA is that you need -- and their actual purpose of Phase II is to determine the dose that you're going to take forward into Phase III and we certainly have done that with the 3-milligram per kilogram dose. The next is the summary of all the safety data and we have really integrated all the safety information from our Phase I and previous Phase II trials, as well as the randomized controlled second-line trial.

And we'll be presenting that entire summary and safety profile of the drug, which is also extremely good and actually better than we anticipated. And the third piece, which is important, is the efficacy piece.

And very -- as I point out to many people, there are very few and far between Phase II trials that ever show statistical significance and efficacy. That's an absolutely unbelievable hurdle for a Phase II product.

And what you're really looking for is a ability to describe that you do have clinical efficacy. And as Joe had said, showing 11.7 months for the 3-milligram arm and a difference in the pooled dataset for the product of 7.3 months when you combine the control and the placebo, definitely gives you the indication that in overall survival, we have a potentially highly efficacious product.

So I think the 3 critical things have been identified. And again, we're going to discuss the entire situation of the investigation with the agency, as well as all the data I just described and we feel pretty confident that we have enough data to move the product effectively into Phase III.

That's helpful Rob. And then, I guess, my follow-up question is I just want to switch gears while staying with bavi.

I guess I'll ask this question from a devil's advocate perspective regarding the pancreatic data. Now Joe, you started to throw some additional plans in there with how you're viewing the data.

But I guess, first, I would ask the question is, response rates are one thing, but in oncology, when you view the gold standard being essentially survival, the study didn't really show a difference in survival. So I guess, before we talk about or get some more color about the plans you alluded to, why were you encouraged with this current study on the pancreatic side, and then maybe just a little more color about what you'd do -- you'd look to be doing next as you look to, like you said, identify maybe a different patient population or what have you?

Sure. Obviously, in pancreatic cancer, it's no secret that it's a difficult-to-treat disease and survival is extremely hard to improve upon.

I think we were encouraged by what we saw in our trial in that despite a very advanced set of Stage IV patients, we still did see some activity in the response rate. And it did translate to, albeit modest, survival, there was still a survival difference in our bavituximab-containing arm.

I think what we -- as I mentioned previously, what we are looking at is how can we -- what's the best way to advance bavituximab in this indication, given what's going on in the space right now. Obviously, with ABRAXANE becoming -- with positive data, that's going to shift the landscape, we believe, and -- but it's not curing pancreatic cancer yet.

So there's potential opportunity there if we can consider adding bavituximab to some of these new -- newer regimen. The other aspect is, clearly, we had -- because we allowed some of these sicker patients, we ended up enrolling some sicker patients and one thing we're learning about the drug is that it does have an immune sort of mechanism and perhaps we have to be a little bit more selective on the type of patients for the development, so that we can -- to give them more of a fighting chance to mount an immune response.

So those are the types of things that we are sort of looking very closely at right now.

So just on that last point, I mean, I guess, that makes sense if you're looking at the immune component of bavi, I guess whether it's some cancer vaccines or immune-related types of therapies, I mean, the speculation is for others that have failed in advanced pancreatic cancer is that the immune systems have not had time to essentially be in engaged or activated because the patients were so far in advanced and would pass away before the immune system could be activated. So that's what you're alluding to?

Yes, I mean, that's a big part of it.

Yes, just to expand on that, because I think that's one of the things we've learned over the last few years in further mechanistic studies and all the work that's been going on in the preclinical side is that there is a kind of a dual activity of the antibody and part of it is sort of this ADCC and the kind of activity you might see early on after just the initiation of reactivating the immune system. And so I think that's the kind of thing that shows up in tumor response rates.

But clearly, the survival benefit is probably mediated through more of boosting the immune system, allowing the immune system to really build up a robust immune response. And as we're talking about here, I think that takes a number of doses to get to that point.

So this study -- and again, I think we look forward to being able to talk about some of the subset data and how we view the program going forward. But certainly, by selecting a slightly healthier patient population as has been done with most of the other studies, which have had recent readouts, you're going to automatically start to extend that sort of time to progression and thereby the number of doses the patients can receive.

Then, I think one of the other beauties of this drug is with the positive safety profile and the fact that we believe any of these chemotherapy combinations will up regulate the target, combining this with now more effective combinations, such as the ABRAXANE combination, now even further extends that runway of getting doses in and stimulating the immune system. So I think we're really anxious now to get together with our advisors and determine the next steps for the program.

But I think there's a lot of really positive things we learned from this study and we can employ in the next study.

My question is on bavi in second-line. You mentioned going to the end-of-Phase II meeting with the agency and possibly proposing a approximately 600-patient trial.

Can you share with us additional information on the powering assumptions that you have there in terms of at least kind of the magnitude of benefit that you'd expect to be able to show out of that size of a trial?

Yes, I think that it's probably premature to come out with too many details on what we're considering here. I think we certainly want to put our best foot forward and put together a plan and present that to the FDA, that they will be able to accept.

So I think it's -- if you look at the standard powering assumptions of other Phase III trials, it's going to be in the same range as those studies are. But again, I think until we have a chance to get some initial feedback from the agency, we probably would want to hold off on announcing too much and sort of putting that out there into people's thinking before we've had a chance to fully vet it out.

That said, Steve, or Joe, perhaps, I mean, when you look at the Phase II and the standard idea is to reduce a little bit in terms of the expectations for the magnitude of benefit, have you taken that similar conservative approach and looked at the magnitude of benefit that you saw in Phase II and cut it by some amount to design your Phase III?

Yes, there's definitely that factored into the powering assumptions. I think, most Phase IIs that are positive, typically [ph] move into Phase IIIs, are not replicated at that magnitude difference, so we recognize that.

You really have to factor in a larger study and perhaps in some sense, a broader total exposure that you can't be quite as bullish.

Yes, so I think, just to expand on that. So basically, we feel like we've taken a pretty conservative approach to the data analysis by including in the combined control arm, both placebo and patients that were receiving active drug.

And so that probably becomes something of a buffer when considering just that aspect. And then as Joe said, on top of that, we're still going one step further and that is planning a Phase III trial that would easily meet that goal, plus some buffering additional built in.

Okay. And then you mentioned possibly presenting a full dataset at -- at a clinical meeting coming up.

Is it possible that ASCO -- that could be ASCO or would it be ESMO or something along those lines. I realize that you probably haven't had abstracts, actually, accepted yet, but is that a possibility?

Yes, it's certainly a possibility.

And then, I guess I assumed that with regard to the pancreatic cancer trial that you just spoke of, as well as the first-line lung cancer trial, you used vendors or CROs than you used in the second-line trial?

Yes, I think while we've certainly used some of the same vendors, I think there's just a basic difference in the trial design of the second-line study versus the other studies. Second-line study, if you remember, was double blind and placebo controlled, which means that there was actually an extra step in which there were vials that were labeled in and every patient received a study drug plus the chemotherapy in the study, whether it was placebo, low-dose or high-dose bavituximab.

In the open label studies, the pancreatic study, as well as the front-line non-small cell lung cancer study, while those were randomized, they were not placebo controlled, so basically, there was only 1 dosage that was provided for patients. So not the same opportunities for the same sorts of things we saw in the second-line study.

That make sense. And then finally, my last question on the investigator-sponsored trials.

First of all, have you been talking to the investigators about how those are going, and are there any settings that you're particularly intrigued with and would like -- look forward to reading out at, at say, ASCO or something like that?

I think we're definitely intrigued by it, by all the ones we support -- we support those that have the potential to lead to some company-sponsored indications. But I think we are really interested in the one with sorafenib with HCC.

That's a fairly large study at the end of the day. It's enrolling well.

And there's a HER2 negative breast study, I think that's interesting, given that we have prior Phase II data in breast cancer that were very promising. I think the front-line combination with pemetrexed in front-line non-small cell lung cancer is also interesting given our current focus in lung cancer.

But I think -- yes, we are constantly getting updates. We do monitor sort of the enrollment and the usage.

But whether data are available, it's really up to the investigators at this point, so....

Yes, and I think, Charles, just to expand on that. So as we think about partnering, and as you know, our stated goals have been primarily ex U.S.

partnering, at least maintaining some commercialization rights in the U.S. Indications like liver cancer become potentially very important, because while it's a relatively small indication in the U.S., it's a very large indication throughout Asia, where the incidence is very high.

So I mean, it also creates more value potential in that regard as well as we're entering into partnering discussions and have ongoing partnering discussions.

Question regarding the pancreatic cancer, going back to that, and your discussion about the immune response and measuring the robustness of -- or speaking about the robustness of the immune response. Was this part of a prespecified endpoint?

And how are you gauging how robust the immune response is? What exactly are you measuring in the pancreatic cancer patients?

Yes, so we have built into some of the investigator-sponsored trials the ability to go in and look at the maturation of the immune response as a better way to gauge that. We did not necessarily build that into the pancreatic cancer study itself.

I think what we're alluding to is the fact that if you look in our trial, we had relatively short median overall survival, again, probably because of the broad nature of our entry criteria into the study. And just the fact that we know from -- even from preclinical studies, that it takes some time to generate and then boost what eventually turns out to be an adaptive immune response in animals that are treated with bavituximab.

And so we're just extrapolating from that into the fact that we really want to pick ideally combinations that will give us enough, in patient populations, that will give us enough doses in patients to potentially achieve that robust immune response.

So are you measuring white blood cell count? Are you measuring antibodies?

Or is it just an extrapolation of your expectation there and you're going to come up with some metrics going forward?

Yes, I think it's more of an extrapolation of our experience throughout other studies and preclinical studies. And just the fact that, again, I think we're recognizing much more now even than we did when we very first designed the study, that this immune stimulation component of bavituximab's activity is probably very important, particularly as it relates to overall survival and that's kind of what you've seen with other immunotherapies as well.

Yes, yes, that's a logical way to interpret it and to look at it going forward and it would be really interesting to see that verified. Okay.

I have another question regarding the Avid business. You say you've got a little bit of a backlog, are you guys running Avid now 24 hours a day?

If I came in and said I need a job, I'd have to wait until your 1Q or 2Q 2014? Are you -- and in that regard, are you planning some expansion?

Yes, so I think we are evaluating expansion. But the way we operate the business is we have a number of different bioreactors, size reactors.

And so at any given time, even with our backlog of business, there is still adequate capacity, depending on the scale, for new clients coming in. So in fact, as you have seen, we've brought on board, not too long ago, another client.

We obviously have our bavituximab production, which is also in the reactors themselves. But, so there's still currently some capacity that we can continue to generate additional revenues and create additional projects from.

But it would really just depend on the size of the reactor and some of them are quite booked up and other ones are relatively available. But certainly, it's a nice growth business and we've been extremely happy with the performance this year.

And like you said, you have to make sure that you build enough -- manufacture enough bavi for all the trials, ongoing trials, and then trials you're expecting to start later on this year and next?

Yes, and I think as Rob alluded to, the fact that a lot of the background work is making sure that -- there's 2 ways to increase capacity, one is productivity of your existing cell line, which means you're just getting more per batch and then there's actually scaling up to different size. So we've been looking after that part of the business also.

In fact, we're in a really strong position going into the Phase III to be able to fully support as many Phase IIIs as we'd like to be able -- that we're likely to run and also looking in the future at commercialization.

Yes, if you increase productivity, that will certainly help your costs going forward, for sure, help save [ph] costs. The event-driven non-small cell lung cancer trial, the first -- the front-line, these patients, after they progress, they probably had a number of different subsequent therapies, which will also probably reflect, to some extent, and then some of them maybe have even gone into some clinical trials, I would imagine.

How are you going to evaluate the overall survival of these patients based on the variety of drugs that they may have taken after they failed the front-line combination?

Yes, I think that's a great question. And clearly, with the survival endpoint, subsequent treatment could affect the outcome.

Yes, the FDA guidance basically weighs the next line of treatment as the primary driver, so our analysis will be looking at primarily what patients went on next, if anything, and if there's significant differences between 2 arms, that is a confounding factor when looking at survival.

I guess, you can group everyone, but I suppose if you have enough patients or multiple patients, I suppose, in any one particular subsequent chemotherapy, then you could maybe -- and whether it's 2 lines or 3 lines, you might be able to compare those, like you said, as a subgroup, is that correct?

Yes, I mean, the study that we have is not terribly large. But if there are some patterns with different classes of chemotherapies, then yes, we'll be looking at sort of pooling those patients.

Of course, the most desirable result would be a difference in survival regardless of what subsequent therapy they went on?

That's right.

Okay. And finally, one last question.

The coding discrepancy, are you putting into place in subsequent trials any additional measures to be sure that there's no repeat?

Yes, I mean certainly, we'll be implementing corrective and preventive actions going forward. We want to make sure that -- clearly, there's no possibly of it happening as much as you can humanly control such things.

So we'll be looking at ways in which we can mitigate in future clinical studies any possibility of this happening. It's such a shocking thing to happen in a clinical study, and we certainly don't want any repeat of this experience.

I want to follow up on one of my earlier questions and I want to ask it a little differently and I'm not sure you're going to answer it, but I'll ask anyway. The earlier question that I had was sort of like your background activities going on right now in prepping for the FDA meeting, and the comfort level that you have to move forward and you did address that and Rob was very helpful, too, in addressing that.

What I was going to ask is on the BP side, obviously without naming names, would you be able to provide any level of anecdotes about during your partnering discussions, the level of comfort your potential discussions are having with regard to moving forward as well?

Yes, sure. So I mean, I think just talking in generalities, I think everyone understands how we did our review of the data.

I think everyone agrees that the way we've done the data analysis is, again, in the end, the most reasonable way and conservative way to analyze the data. We haven't tried to take advantage or stack things in our favor.

So I think in general, there's been a comfort level with those activities, with the results. I think, as with all of us, right, I mean, they're just now looking forward to continuing the review, continuing their diligence and looking forward to the FDA meeting next and then what is the final Phase III trial design look like and all those sort of related activities to getting ready for a Phase III study toward year end.

And I guess it might be a fair assumption whether a term sheet is ultimately signed or not that the visibility surrounding your end-of-Phase II meeting would be very important to a potential partner?

Yes, I mean, I think naturally, everyone looks at your next kind of milestone coming up and that's just seen as the next big milestone of meeting with the FDA, getting our plans for Phase III in front of them, getting some sort of buyoff. And just as a comfort level, it gives people more confidence as you're moving, again, toward the Phase III study.

Okay. I'd like to thank all of you again today for joining us for the quarterly conference call.

As we outlined today, this is an exciting time for Peregrine, and we are positioned for several near-term milestones. We hope that you share our enthusiasm.

I look forward to updating you over the next quarter. Thank you, again.