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` Mitchell deLong
`UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _____________________________
`MICRO LABS LIMITED and MICRO LABS USA INC.
` Petitioners
` v.
` SANTEN PHARMACEUTICAL CO., LTD. and
` ASAHI GLASS CO., LTD.
` Patent Owners
` _____________________________
` Case IPR2017-01434
` U.S. Patent No. 5,886,035
` _____________________________
`
` DEPOSITION OF MITCHELL deLONG
` Washington, D.C.
` July 12 2018
`
`Reported by: Mary Ann Payonk
`Job No. 143913
`
`TSG Reporting - Worldwide 877-702-9580
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`Santen/Asahi Glass Exhibit 2061
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
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`
`
` Mitchell deLong
`UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _____________________________
`MICRO LABS LIMITED and MICRO LABS USA INC.
` Petitioners
` v.
` SANTEN PHARMACEUTICAL CO., LTD. and
` ASAHI GLASS CO., LTD.
` Patent Owners
` _____________________________
` Case IPR2017-01434
` U.S. Patent No. 5,886,035
` _____________________________
`
` DEPOSITION OF MITCHELL deLONG
` Washington, D.C.
` July 12 2018
`
`Reported by: Mary Ann Payonk
`Job No. 143913
`
`TSG Reporting - Worldwide 877-702-9580
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`Santen/Asahi Glass Exhibit 2061
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
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` Mitchell deLong
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`Page 2
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` July 12, 2018
` 9:00 a.m.
`
` Deposition of Mitchell deLong, held at
`the offices of Pillsbury Winthrop Shaw Pittman
`LLP, 1200 Seventeenth Street, N.W., Washington,
`D.C., pursuant to Notice before Mary Ann
`Payonk, Nationally Certified Realtime Reporter
`and Notary Public of the District of Columbia,
`Commonwealth of Virginia, and State of New
`York.
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` Mitchell deLong
`APPEARANCES:
`ON BEHALF OF PATENT OWNERS SANTEN
`PHARMACEUTICAL CO., LTD., and ASAHI GLASS CO.,
`LTD:
` ARLENE CHOW, ESQUIRE
` ERNEST YAKOB, ESQUIRE
` HOGAL LOVELLS US
` 875 Third Avenue
` New York, New York 10022
`
`ON BEHALF OF PETITIONERS:
` CEDRIC TAN, ESQUIRE
` YUN WEI, ESQUIRE
` ALTON HARE, ESQUIRE
` PILLSBURY WINTHROP SHAW PITTMAN
` 1200 Seventeenth St., N.W.
` Washington, D.C. 20036
`
`ALSO PRESENT:
` Lilith Short, Legal Video Specialist
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` Mitchell deLong
` THE VIDEOGRAPHER: This is the
`start of tape labeled number 1A of the
`videotaped deposition of Mitchell deLong
`in the matter of Micro Labs Limited and
`Micro Labs USA Incorporated versus
`Santen Pharmaceutical Company et al. in
`the Court of the Patent Trial and Appeal
`Board, Case Number 1PR2017-01434.
` This deposition is being held at
`1200 17th Street, Northwest, Washington,
`D.C. on July 12, 2018 at approximately
`9:26 a.m.
` My name is Lilith Short from
`TSG Reporting, Inc., and I'm the legal
`video specialist.
` The court reporter is Mary Ann
`Payonk in association with
`TSG Reporting.
` Will counsel please introduce
`yourselves?
` (Whereupon, counsel placed their
`appearances on the video record.)
` THE REPORTER: I'll swear the
`witness.
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` Mitchell deLong
`MITCHELL DELONG,
` called as a witness, having been duly
` sworn, was examined and testified as
` follows:
` EXAMINATION
`BY MS. CHOW:
` Q. Dr. deLong, this is the second time
`that I've taken your deposition; correct?
` A. Yes.
` Q. You've just been sworn in, but just
`for clarity, are you suffering from any malady
`or illness that would impact your ability to
`testify truthfully and accurately today?
` A. No.
` Q. Are you taking any medication that
`would impact your ability to testify truthfully
`and accurately today?
` A. No.
` Q. And can we agree that if you do not
`understand a question that I pose, that you
`will seek clarification?
` A. I will.
` Q. And can we also agree that if you
`answer a question that I pose, that you
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` Mitchell deLong
`understand the question as posed?
` A. As I said last time, I will answer it
`as I understand the meaning of the terms, yes.
` MS. CHOW: Okay. Dr. deLong, I'm
` handing you a document that was
` previously marked as Micro Labs
` Exhibit 1003.
` THE WITNESS: Thank you.
` (Micro Labs Exhibit No. 1003, previously
` marked, was referenced and indexed.)
`BY MS. CHOW:
` Q. Do you recognize Exhibit 1003,
`Dr. deLong?
` A. I do.
` Q. Okay. And do you see that on the
`right-hand side of the document, the first
`named inventor's last name is Klimko,
`K-L-I-M-K-O?
` A. Yes.
` Q. Okay. And this is a European patent
`application with the publication number
`0639563. Do you see that?
` A. Yes.
` Q. Okay. I'd like to direct your
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` Mitchell deLong
`attention to table 4. Table 4 is on Micro Labs
`Exhibit 1003-18. Can you please turn to that
`page?
` A. Yes.
` Q. Now, you have rendered opinions in
`this action in relation to Exhibit 1003;
`correct?
` A. Yes.
` Q. Okay. And for table 4, I'd like to
`direct your attention to Compound C. That's
`the third compound. And it is identified as
`16-phenoxy-17,18,19,20-tetranor-PGF2alpha. Do
`you see that?
` A. Yes.
` Q. Do you agree that the mean percent
`IOP reduction goes down for Compound C at 2 and
`4 hours after administration of the fifth dose?
` A. I'm sorry, what was your question?
`What are you comparing it to?
` Q. Do you agree that the mean percent
`IOP reduction goes down for Compound C at 2 and
`4 hours after administration of the fifth
`dose --
` A. So "down" is a somewhat ambiguous
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` Mitchell deLong
`term, since this is a percent reduction. The
`number goes from 25 at 2 hours after, to 23.6
`at 4 hours after.
` Q. Right. So at 16 hours after the
`fourth dose, the mean was 30.2; correct?
` A. That's correct. That represents the
`longest time since the dose, 16 hours since the
`previous dose.
` Q. And at 2 hours after the fifth dose,
`the IOP changed from a mean of 30.2 to a mean
`of 25.3; is that correct?
` A. So remember, these are percent
`reductions, so to be technically accurate we'd
`have to say it was minus 30 percent as an
`average, and then it was minus 25.3 percent as
`an average. It's still minus 25 percent.
` Q. Right. So 4 hours after -- sorry,
`strike that.
` 16 hours after the fourth dose, the
`mean percent IOP reduction was 30.2, and that
`changed such that at 2 hours after the fifth
`dose the mean was 25.3 percent, and 5 hours
`after the fourth dose, the mean was -- 4 hours
`after the fifth dose, the mean was 23.6; right?
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` Mitchell deLong
` MR. TAN: Objection to form.
` A. Is that multiple questions?
` Q. I can go back to my original question
`which I think you'll agree. Hold on.
` Do you agree that for Compound C, the
`mean percent IOP reduction went down from the
`16 hours after the fifth dose to -- oh my gosh,
`the 4 hours to the fifth dose?
` MR. TAN: Objection to form.
` A. I'm not sure I followed your
`question.
` Q. Sorry. I said fourth instead of
`fifth apparently. Okay. Do you agree that the
`mean percent IOP reduction goes down for
`Compound C from 16 hours after the fourth dose
`to 2 hours after the fifth dose?
` MR. TAN: Objection to form.
` A. I believe I already answered that
`question.
` Q. And what was your answer?
` A. That you can't use the word "down"
`because it's ambiguous because this is a change
`in a reduction that's already a negative, and
`so you want to be careful not to do that. But
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` Mitchell deLong
`I can elaborate, if you will.
` Q. What phrase would you use?
` A. I would say that the number is
`changed.
` Q. Okay.
` A. But I would also add the caveat that
`you can't take a mean without understanding the
`standard error or standard deviation, because
`the number, in the absence of understanding the
`difference and the spread in the data, is
`almost meaningless, not quite meaningless,
`but -- so you have to say, well, it went from
`30 plus or minus 4, 4 and a half or so, to 25
`plus or minus 4 and a half or so, and then you
`look at -- it doesn't actually show statistical
`significance so you have to look at the error
`bars.
` So one way of estimating it would be
`to see how much overlap if any there is in the
`error bars, and the high end of the error bar
`would be 4.4 from 30, which would drop it down
`to somewhere around 26 and change. The low end
`of the error bar's on the 2 hours after the
`fifth dose, 4.5 plus 25 would be somewhere
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` Mitchell deLong
`around 29. That's a pretty significant
`overlap. So I don't think, looking at these
`numbers in the actual context, with
`understanding what they represent, is the
`average that one can really say there's really
`a difference between these two numbers.
` Q. So given that there is overlap in the
`error bars, is it your position that there is
`no statistically significant change from 16
`hours after the fourth dose to 2 hours after
`the fifth dose and to 4 hours after the fifth
`dose?
` MR. TAN: Objection to form.
` A. That's a -- multiple questions.
` Q. Is it your position that there is no
`statistically significant difference between
`the three time points?
` A. Since statistics are not actually
`given on -- in the data, they don't actually
`list the statistical significance, we can't
`know for sure.
` Q. But you're not able to draw any
`conclusions -- strike that.
` Is it your position that you're
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` Mitchell deLong
`unable to conclude that there is statistical
`significance based on the fact that the error
`bars overlap from one time point to the next?
` A. No, that's not my position at all.
` Q. What is your position?
` A. My position is you can conclude
`definitively if the author has presented
`statistical significance. If you're looking at
`error bars and overlap, you're estimating or
`trying to come up with a reasonable substitute
`for the lack of a rigorous statistical
`analysis.
` Q. Is it your position that there is no
`trend in the numbers for Compound C as you move
`from 16 hours after the fourth dose to 4 hours
`after the fifth dose?
` MR. TAN: Objection, form.
` A. No.
` Q. Is there a meaningful difference
`between the time points of 16 hours after the
`fourth dose, 2 hours after the fifth dose, and
`4 hours after the fifth dose in relation to
`Compound C?
` MR. TAN: Objection to form, vague.
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` Mitchell deLong
` A. I would agree it's a very vague
`question and it's also a multiple part
`question.
` MS. CHOW: Counsel, you're only
` permitted to say "objection to form."
` You're not allowed to permit -- you're
` not permitted to state the basis because
` that's coaching the witness. So from
` here on out I think in order to be in
` accordance with the procedures of this
` court, you should just state "objection
` to form."
` MR. TAN: I disagree. There was no
` coaching of the witness here.
` MS. CHOW: You're not allowed to
` state the basis for the objection to the
` form and you know it, counsel. I'm
` going to ask the question again.
`BY MS. CHOW:
` Q. Is there a meaningful difference
`between the time points of 16 hours after the
`fourth dose, 2 hours after the fifth dose, and
`4 hours after the fifth dose in relation to
`Compound C?
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` Mitchell deLong
` MR. TAN: Same objection.
` A. I agree that "meaningful" is a
`subjective term.
` Q. In your opinion, is there a
`difference between those three time points in
`relation to Compound C?
` MR. TAN: Objection to form.
` A. My analysis of Compound C indicates
`that -- that there is a trend between the 16
`hours after the fourth dose, where the number
`is 30.2 plus or minus 4.4, and including the 2
`hours after the fifth dose and ending at 4
`hours after the fifth dose.
` Q. What is that trend?
` A. The trend is for the decrease to
`become less pronounced.
` Q. And is that decrease, in your
`opinion, due to the active form of Compound C
`not yet being available in the eye in high
`enough levels at 2 and 4 hours after the fifth
`dose?
` A. I believe that's a compound question.
` Q. You may answer it.
` A. A measurement of 25.3 or 23.6 percent
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` Mitchell deLong
`reduction from baseline indicates that there is
`the presence of sufficient compound to lower
`the IOP. If there was not sufficient compound
`to lower the IP --IOP, the number would read
`zero.
` Q. And so would the mean IOP reduction
`drop from 30 to 0 in 2 hours if there was no
`more active form of Compound C?
` MR. TAN: Objection to form.
` A. If there were no active form of
`Compound C, it would not be able to exert a
`physiological effect. In the absence of a
`physiological effect, it would return to
`baseline, which is 0.
` Q. And that would be within 2 hours?
` A. I didn't say that -- the time frame,
`I just said at a certain point in time, if
`there were not sufficient compound, which is
`what you asked me, what would the number be,
`and the number would be 0. The fact that it's
`not 0 indicates that there is sufficient
`compound, which I think is what you were
`asking. Do you want to restate the question or
`ask the same question again?
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` Q. Do you know how long it would take
`for the mean IOP reduction to drop from 30 to 0
`in relation to Compound C?
` MR. TAN: Objection to form.
` A. No.
` Q. Why not?
` A. Every compound is metabolized and
`processed differently.
` Q. What would you need to know in
`order -- strike that.
` What would you need to know in order
`to determine how long it would take for the
`mean IOP reduction to drop from 30 to 0 for
`Compound C?
` MR. TAN: Objection to form.
` A. Some compounds are particularly
`long-lived. These compounds would take longer
`to go back to baseline than other compounds,
`which might go back to baseline more quickly.
`So you would need to do a study where you dose
`the compound and then you stop dosing and then
`you measure the length of time it takes to go
`back to baseline.
` Q. And that study was not reported in
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` Mitchell deLong
`Exhibit 1003 for Compound C; correct?
` MR. TAN: Objection to form.
` A. In this particular paper? Is that
`what you're asking?
` Q. Yes.
` A. This paper doesn't report that exact
`study; however, it does indicate that the
`number went down from 6 hours after a dose to
`16 hours after a dose, which indicates that
`it's a long-lived compound.
` Q. It went down from 6 hours after a
`dose to 16 hours after a dose. Were you
`accurate in your answer just now?
` MR. TAN: Objection to form.
` A. The number at 6 hours after a dose
`that's reported is minus 28.9. The number at
`16 hours after a dose is minus 30. Minus 30 is
`a lower number than minus 28.9.
` Q. What did you mean by "went down"?
` MR. TAN: Objection to form.
` A. As I just stated, the negative number
`minus 28.9 went to minus 30.2.
` Q. So in determining that the IOP number
`went down, you were comparing the mean number,
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` Mitchell deLong
`weren't you, from one dose to the next?
` A. I was reading the numbers off of this
`chart, yes. Are you asking a different
`question? Is there a statistically significant
`difference?
` Q. That wasn't my question.
` A. Okay.
` Q. My question was whether or not you
`were focusing on the mean number in
`characterizing the figure as going down.
` A. I read the numbers, yes.
` Q. Now, there's no data in Klimko
`regarding the level of active drug in the eye
`at different time points; right?
` A. I am not aware of it.
` Q. And Klimko doesn't provide any
`percent IOP reduction data for a time point
`longer than 16 hours; right?
` MR. TAN: Objection to form.
` A. In this chart on table 4? Is that
`what you're asking? Yes, that's true.
` Q. Okay. Let's go to page Micro Labs
`Exhibit 1003-16. So you're going to flip back
`two pages, Dr. deLong. So I'm going to direct
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` Mitchell deLong
`your attention to the hyperemia scoring scale.
`Do you see that in Klimko at Micro Labs
`Exhibit 1003-16?
` A. I do.
` Q. Is it your opinion that a score of 3
`in Klimko is moderate hyperemia?
` A. That would be one way to characterize
`it.
` Q. What's another way of characterizing
`it? Severe?
` MR. TAN: Objection to form.
` A. I think different investigators use
`different ways of characterizing these numbers
`depending on their knowledge at the time and
`their understanding of the relationship between
`hyperemia and irritation.
` Q. What other characterizations would
`investigators use to a score of 3?
` MR. TAN: Objection to form.
` A. I can't speak for all investigators.
`There are probably any number of adjectives
`that would take the place of an actual number.
` Q. Do you agree that a score of 3 in the
`hyperemia scoring scale as set forth in Klimko
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`is moderate?
` A. I believe I said that's a term that
`people use -- that people might use to describe
`that number. It's an adjective that might be
`used.
` Q. Have you ever characterized the score
`of 3 in Klimko Exhibit 1003-16 as representing
`moderate hyperemia?
` A. I don't recall every use of -- every
`adjective I've ever used to describe these
`data, so I can't rule it out.
` Q. So how do you characterize a score of
`3 in the hyperemia scoring scale as set forth
`in Klimko?
` A. So one does not in general
`characterize a number in the absence of
`understanding, again, the statistics and the
`spread. This actually is meant to help you
`understand the chart, which is on the next
`page, which shows that different drugs at
`different guinea pigs give different scores at
`different times.
` Q. Let's do it this way.
` A. So it's not one particular score,
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`it's the aggregate and understanding the
`standard deviation or other statistical
`applications that allows you to understand;
`right? You just don't have a number 3 out
`there all by itself. It has to be understood
`in terms of the rest of the test.
` Q. I want to go back to the scores,
`okay. You see there's scores of 0, plus 1,
`plus 2, plus 3 and plus 4; right?
` A. Returning to page 16?
` Q. Oh, yes. Do you see those scores?
` A. Yes.
` Q. Which score correlates to mild
`hyperemia?
` MR. TAN: Objection to form,
` foundation.
` A. Again, he defines 2 to 4 as
`indicating hyperemia, and as I see it, I don't
`see any adjectives here in this -- am I missing
`an adjective? It says scores of 0 to 1
`indicate no hyperemia, scores of 2 to 4
`indicate hyperemia, a score of 4 indicating the
`most. I don't see where he defines that term.
` Q. So you take issue with any
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` Mitchell deLong
`characterization that a compound associated
`with a score of 3 has moderate hyperemia?
` MR. TAN: Objection to form.
` A. No.
` Q. So you would agree that a compound
`associated with a score of 3 has moderate
`hyperemia?
` A. No.
` Q. Is it your position that a compound
`associated with a score of 3 has mild
`hyperemia?
` MR. TAN: Objection to form.
` A. My position is that those terms are
`not defined in this chart.
` Q. So you would not apply the terms
`"mild," "moderate," or "severe" to any compound
`associated with any of these scores of 0, 1, 2,
`3, and 4; is that right?
` MR. TAN: Objection to form.
` A. I believe I've already answered that
`question several times.
` Q. Is there a score, in your opinion,
`that is associated with severe hyperemia?
` A. Again, I've answered this question
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` Mitchell deLong
`multiple times. You can't look at just a score
`in the absence of the data associated with a
`specific compound and understanding the
`statistical variation of the compound in this
`particular assay as shown on page 17. For
`example, Compound A at 0.3 micrograms has
`23 percent of the scores are 0, 61 percent are
`1, 13 percent are 2, and 3 percent are 3. So
`you can look at those in aggregate and
`understand the assay and make some conclusion,
`but you can't just say, well, we're just going
`to look at a number and tell about you a
`compound.
` Q. Do you agree that a compound which
`has a score of 3 has more pronounced hyperemia
`than a compound with a score of either 2 or 1?
` A. Again, you can't make those
`assertions in the absence of looking at all the
`data. There may be so much spread in the data,
`for example, a higher dose level should give
`more hyperemia, but in the case of some
`compounds on this list, the higher dose level
`gives rise to less hyperemia, which doesn't
`make sense. So you have to take all of these
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` Mitchell deLong
`data into consideration and you can't just
`make -- although it may be convenient, you
`can't just make broad generalizations.
` Q. Let's look at the data. So if you go
`to table 3. That's on Exhibit 1003-17. I'd
`like you to look at the data for Compound C.
`And do you agree that there was a 38 percent
`incidence of a score of 3 for 0.3 micrograms of
`Compound C?
` A. The data here present, under a score
`of 3 for 0.3 micrograms of Compound C,
`38 percent of the -- of the measurements or the
`observations were scored by the investigators
`at 3 in conjunction with, again, all of the
`data on this -- on the chart and an
`understanding of this model, which I have
`actually tested compounds in the same model, so
`I understand it very well. And I understand
`the limitations. I understand if people are
`not particularly experienced with it, might be
`difficult because they'd just like to take the
`numbers at face value and maybe even use them
`out of context. But you have to understand the
`entire test if you want to be scientifically
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`complete and accurate and fair.
` Q. What literature are you aware of that
`reflects the fact that a 38 percent incidence
`of a score of 3 is clinically acceptable?
` MR. TAN: Objection to form.
` A. Obviously you're asking a very
`specific question that 38 percent in this assay
`without what the other percentages were, which
`you didn't mention, and then you jumped from
`that to clinically acceptable, and then you
`asked if there were specific data that linked
`that. As far as I know, this is the only data
`point that reflects a 38 percent number of the
`reported observations having a 3. So among
`any -- I don't think it's ever been repeated,
`so I don't -- not that I'm aware of anyway. So
`I don't think that you can make that kind of
`statement.
` Q. What percentage incidence of score 3
`of hyperemia in your opinion would be
`clinically unacceptable?
` MR. TAN: Objection to form.
` A. Again, I've already answered this
`question. Right? You have to understand, not
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` Mitchell deLong
`an isolated number. You have to understand the
`entire assay. You have to understand what the
`other numbers were besides 38 percent. You
`have to understand how many times this has been
`done. You have to understand even if that's a
`clinically relevant dose; right? You're just
`ignoring all of that and saying I'm supposed to
`pick a number, it's 38 percent, do we know
`that .03 is even the clinically relevant dose?
`And it's also known and it was known in 1996
`that the guinea pig assay overestimates the
`amount of hyperemia you'll see in humans.
` So you have to take all that into
`consideration. You can't just make statements
`like that and expect -- it's not even a
`rational statement or question.
` Q. So the data reported in table 3 of
`Klimko is deficient in your view; is that
`right? Or at least the model is?
` MR. TAN: Objection to form.
` A. Again, let's not jump from overly
`praising the model to overly criticizing the
`model. The model has limitations. People who
`are skilled in the art of testing
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` Mitchell deLong
`prostaglandins for hyperemia in guinea pig
`understand the benefits and the limitations of
`the model. Just like every model has benefits
`and limitations.
` Q. Compound B, which is identified as
`fluprostenol, that is also known as travoprost;
`correct?
` A. No.
` Q. Oh, I got it -- yeah, okay. I got
`it. Compound B is travoprost; right?
` A. I'm sorry?
` Q. Is Compound B travoprost?
` A. Compound B as in boy?
` Q. Yeah.
` A. No.
` Q. Is it your understanding that there
`is no data for travoprost reported in table 3
`of the Klimko reference?
` A. No.
` Q. Of the compounds A, B, C, D and E, do
`any of those compounds represent travoprost?
` A. Let me help you out because you're a
`little frustrated.
` Q. Yeah.
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` A. Travoprost is a single -- the minus
`enantiomer of fluprostenol, which is a
`racemate. So travoprost is contained within
`the fluprostenol as one of two enantiomers.
`Enantiomers are mirror images of each other so
`that one is sort of, if you will, a
`right-handed molecule, the other is, if you
`will, a left-handed molecule, although there
`are multiple stereocenters in a molecule.
` Q. Can you go back to Micro Labs
`Exhibit 1003-15. Do you see the depiction for
`Compound B in table 2 of Micro Labs
`Exhibit 1003-15?
` A. Yes.
` Q. Is the compound depicted as Compound
`B also known as travoprost?
` A. Again, to somebody who's not
`particularly skilled in the field, they may not
`appreciate the difference, but prostaglandin
`chemists know that prostaglandin structure is
`always drawn such that it matches the structure
`of the naturally occurring prostaglandin. But
`fluprostenol, as a marketed drug, which was
`drawn the same way, was, in fact, a racemate.
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` Mitchell deLong
`So only 50 percent of the molecules actually
`had that particular structure even though by
`convention, we only draw one structure rather
`than drawing both structures every time.
` Q. Okay. Let's look at the data for
`Compound B. Now -- and we're back in table 3
`so -- which is Micro Labs Exhibit 1003-17; all
`right? So if you can look at the row for
`Compound B, in Klimko, Compound B had a
`4 percent incidence of score 3 at 0.3
`micrograms; is that right?
` A. In this chart, the number -- the
`scores are 7 -- for that -- for fluprostenol,
`Compound B, 0.3 micrograms. Score of 17 for
`0 -- percent number of recorded incidence, 50
`were 1, 50 percent. 29 percent, 2. 4 percent,
`3.
` Q. Right. So for Compound B there was a
`4 percent incidence of score 3 at
`0.3 micrograms; right?
` MR. TAN: Objection to form.
` A. I believe I already answered that
`question.
` Q. As yes?
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` Mitchell deLong
` A. I answered the question by reading
`the data.
` Q. Do you see that Compound C reports a
`38 percent incidence of score 3 whereas
`Compound B reports a 4 percent incidence of
`score 3 at the same dose?
` A. Was there a question there?
` Q. I'm asking you if you see it.
` A. Do I see -- again, we've already
`answered this question.
` Q. No, you didn't because this time I'm
`asking you the question comparing Compound C to
`Compound B. So no, actually I have not asked
`that precise question, Dr. deLong.
` MR. TAN: Objection to form.
` Argumentative.
` A. My apologies. You'd previously asked
`if I had seen 38 percent for C, and you'd
`previously asked if I had seen 4 percent for B,
`and I answered those questions. Now you're
`asking separate question but related, do I see
`both at the same time. I would say, as I said
`before, C, .3 micrograms, the data reported
`here, 0 percent zeros. 0 percent of the
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`recorded incidence are 1. 62 percent, 2.
`38 percent, 3 for Compound C. Compound B,
`17 -- at 0.3 micrograms, 17 percent of the
`recorded incidence were 0, 50 percent, 1.
`29 percent, 2. And 4 percent, 3.
` Q. Do you agree that Compound C had
`almost 10 times the incidence of score 3 at
`0.3 micrograms than Compound B?
` A. Again, while it would be easy to look
`at numbers and compare numbers in the isolation
`without understanding the assay, without
`understanding the variability in the assay and
`the significance of those numbers, it would be
`very easy, and I'm sure you would prefer, if
`people just said oh, yeah, sure. But I
`disagree.
` Q. Is it your position that there's no
`difference between Compound C and Compound B in
`relation to the incidence of a score of 3 at
`0.3 micrograms?
` A. As I mentioned before, we go from
`overly praising an assay to overly criticizing
`an assay. Either the number is 10 times better
`or there's no difference at all. I disagree
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