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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__
`______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`AZURITY PHARMACEUTICALS, INC.,
`Petitioner,
`v.
`HELSINN HEALTHCARE S.A.,
`Patent Owner.
`________________
`IPR2025-00945,
`8,623,826
`IPR2025-00946,
`9,186,357
`IPR2025-00947,
`9,186,357
`IPR2025-00948
`9,943,515
`IPR2025-00949
`10,828,297
`________________
`CONFIDENTIAL DEPOSITION OF STEPHEN J. PEROUTKA
`Palo Alto, California
`Tuesday, January 13, 2026
`REPORTED BY: Derek L. Hoagland
`CSR No. 13445
`HELSINN EXHIBIT 2086
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00948
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________
` AZURITY PHARMACEUTICALS, INC.,
` Petitioner,
` v.
` HELSINN HEALTHCARE S.A.,
` Patent Owner.
` ________________
` IPR2025-00945,
` 8,623,826
` IPR2025-00946,
` 9,186,357
` IPR2025-00947,
` 9,186,357
` IPR2025-00948
` 9,943,515
` IPR2025-00949
` 10,828,297
` ________________
`Deposition of STEPHEN J. PEROUTKA, taken before Derek L.
`Hoagland, a Certified Shorthand Reporter for the State
`of California, commencing at 9:20 a.m., Tuesday, January
`13, 2026, at Wilson Sonsini Goodrich & Rosati, 650 Page
`Mill Road, Palo Alto, California 94304.
`CONFIDENTIAL
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`APPEARANCES:
`COUNSEL FOR PETITIONER
`WILSON SONSINI GOODRICH ROSATI
`1700 K Street NW
`Washington, District of Columbia 20006
`BY: RICHARD TORCZON, ESQ.
` 202.973.8811
` rtorczon@wsgr.com
`-- AND --
`WILSON SONSINI GOODRICH ROSATI
`701 5th Avenue
`Seattle, Washington 98104
`BY: GARRETT POTTER, ESQ. (Via Zoom)
` gpotter@wsgr.com
`COUNSEL FOR PATENT OWNER
`PAUL HASTINGS
`200 Park Avenue
`New York, New York 10166
`BY: ISAAC ASHKENAZI, ESQ.
` isaacashkenazi@paulhastings.com
` -- and --
`BY: JUSTIN FLEISCHACKER, ESQ.
` justinfleischacker@paulhastings.com
`-- AND --
`PAUL HASTINGS
`2050 M Street NW
`Washington, District of Columbia 20036
`BY: PETER CHETAN, ESQ. (Via Zoom)
` peterchetan@paulhastings.com
`ALSO PRESENT
`Luisa Barorelli
`CONFIDENTIAL
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` I N D E X
`WITNESS PAGE
`STEPHEN J. PEROUTKA
`EXAMINATION BY MR. ASHKENAZI 5
` E X H I B I T S
` EXHIBIT DESCRIPTION MARKED
` 1009 Declaration 8
` 2036 Review Article Titled "Pharmacology 49
` Management of Chemotherapy-Induced
` Nausea and Vomiting Focus on Recent
` Developments."
` 1010 Herrstedt 52
` 1030 Review 54
` 1013 MASCC Reference 70
` 1014 Bös Reference 142
` 1023 Campos 145
` 2016 Emend 150
` 1030 Emend IV Fosaprepitant Label 151
` 1039 One of the References Discussed in 166
` Declaration
` 1037 Hesketh Reference 184
` 1034 Warr Reference 184
` 2073 Schmoll Reference 220
` 1016 Herrington Reference 223
` 1011 Hoffmann 267
` 1001 Document 282
` 1035 Grunberg Reference 288
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`9:20 p.m. P R O C E E D I N G S
` (Whereupon, the deponent is duly sworn by the
`court reporter.)
` STEPHEN J. PEROUTKA,
` having first been duly sworn,
` was examined and testified as follows:
` EXAMINATION
`BY MR. ASHKENAZI:
`Q. Dr. Peroutka, how are you today?
`A. I'm good.
`Q. Just for the record, can you please state your
`full name for the record?
`A. Sure. Stephen Joseph Peroutka.
`Q. And what's your current address?
`A. 3665 Via Mar Monte, three words, Carmel,
`California 93923.
`Q. Have you been deposed before?
`A. Yes.
`Q. About how many times?
`A. Five to ten.
`Q. Okay. And, generally, were those related to
`patent cases?
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`A. Yes.
`Q. Would you say all of them are?
`A. Possibly, one 30 years ago, it was a clinical
`case, but the rest were patents.
`Q. And were you on which side of -- in the cases,
`the patentee side or the challenger side?
`A. Both.
`Q. Both. Okay. Just so we're on the same page, I
`just want to go over some basics.
` You understand you are testifying under oath
`today, correct?
`A. Correct.
`Q. Is there any reason you cannot provide full and
`truthful and accurate testimony today?
`A. No.
`Q. Okay. If you don't understand a question that I
`ask, I -- could you let me know?
`A. Yes.
`Q. All right. And just so we're on the same page,
`you have to give verbal answers. Head nods aren't going
`to suffice because we don't have a videographer here
`today.
`A. Yes.
`Q. All right. Great. I am going to do my best not
`to speak over you. I will -- I'll ask that you do the
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`same. Let me finish my question before you start
`answering. It's really mainly for the court reporter
`and for your counsel to be able to object.
` Is that fair?
`A. Yes.
`Q. Okay. If we need to take -- we will try to take
`breaks about every hour. The only thing I will ask is
`that if we have a question pending, you answer the
`question before we take a break. Is that fair?
`A. Yes.
`Q. Okay. And we will try to take lunch before
`12 o'clock. So if that works for you.
`A. Okay. That's fine.
`Q. All right. Great.
` Generally, when did you start working on this
`matter?
` MR. TORCZON: Objection. Relevance.
` THE DEPONENT: I believe late 2024.
`BY MR. ASHKENAZI:
`Q. Okay. And how much time would you say you have
`spent on this matter since late 2024?
` MR. TORCZON: Same objection.
` THE DEPONENT: It's difficult to answer because
`it's been split up and pretty quiet for the last eight,
`nine months, but let me try to estimate. Forty to
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`fifty.
`BY MR. ASHKENAZI:
`Q. Okay. 40 to 50 hours?
`A. Hours.
`Q. Okay. If you -- in front of you, you have a
`copy of Exhibit 1009. That's your declaration that you
`submitted in the matters we are dealing with today,
`correct?
` (Exhibit No. 1009 marked for identification.)
` THE DEPONENT: It looks like it is, yes.
`BY MR. ASHKENAZI:
`Q. Okay. Great. If you need to refer to it, I
`want to make sure you have it in front of you if you
`need. I know it's pretty lengthy, over 700 pages or so.
`Is that right?
`A. Yes.
`Q. Did you draft that?
`A. Large part, yes.
`Q. Then so these are your words?
`A. The majority, yes.
`Q. Okay. Have you reviewed your declaration before
`in preparation for your deposition today?
`A. Yes.
`Q. Okay. Is there anything you want to correct in
`your declaration?
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`A. No.
`Q. Okay. What did you do to prepare for today's
`deposition?
` MR. TORCZON: Objection. Relevance to the
`extent it gets into attorney-client privilege. I may
`stop you from answering, but go ahead, answer.
` THE DEPONENT: I re-reviewed, reimmersed myself,
`is how I would put it, into this work of the
`declaration. It was mostly created earlier this year
`and, like I said, it had been a long layover, so I
`reread it, went through it, looked at a lot of the
`exhibits that I have reviewed previously, and then we
`had a couple tele -- one teleconference last week for a
`couple hours or so, and then I came up here yesterday
`and did some preparations.
`BY MR. ASHKENAZI:
`Q. Okay. Did you review any documents that are not
`included or referenced in your declaration in
`preparation for the deposition?
` MR. TORCZON: Same objections.
` THE DEPONENT: Not in terms of preparation. I
`read science constantly, so I -- I am actively still
`involved in clinical research and I may have read
`something that overlapped, but nothing targeted
`specifically for today.
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`BY MR. ASHKENAZI:
`Q. Are you aware of a -- a Dr. Navari?
`A. I'm sorry?
`Q. Have you ever heard of a Dr. Navari,
`N-a-v-a-r-i?
`A. I've seen the name --
`Q. Okay.
`A. -- in publications but I don't know him.
`Q. Okay. Have you reviewed --
`A. Or her.
`Q. Have you reviewed a declaration by Dr. Navari?
`A. No.
`Q. Okay. You said you've reviewed some
`publications from Dr. Navari. Is that accurate?
` MR. TORCZON: Objection. Misstates.
` THE DEPONENT: For the declaration, he may have
`been an author on a few of the papers, but I can't
`honestly say.
`BY MR. ASHKENAZI:
`Q. Okay. Apologies. One second. I think you
`said -- I asked you if you have heard of Dr. Navari, and
`you said, "I have seen his name in publications."
` Is that right?
`A. As an author of certain publications.
`Q. Okay. Do you know the subject matter of those
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`publications?
`A. Not all of them, no.
`Q. Do you know the subject matter of any of the
`publications that Dr. Navari authored that you reviewed?
`A. My honest answer is, I read the authors' names
`when I read a paper to see if I know anyone, to be
`honest with you, and I only recall two names of people
`that I -- I know or I have spoken to, so I can't point
`to the papers he wrote.
`Q. What are those two names?
`A. Dr. Graduala is -- when I did research on nausea
`and vomiting a long time -- in the 1980s, he was a major
`key opinion leader, and I can recall meeting him and/or
`speaking with him about a project study I wanted to do.
`And then Scott Ryanis, who is one of the coauthors on
`one of the aprepitant papers, was at Johnson & Johnson
`when I was there about 20 years ago, and I knew him
`through other work that he had done.
`Q. Okay. Other than your counsel, did you speak to
`anyone in preparation for your deposition today?
`A. No.
`Q. Okay. Now, as I mentioned, you have
`Exhibit 1009 in front of you. That's your expert
`declaration. You understand that there are four patents
`at issue in these matters, correct?
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`A. Yes.
`Q. Okay. And you submitted one declaration related
`to all of the patents, correct?
`A. Yes.
`Q. Okay. And just for the sake of the record, the
`IPRs we're going to be discussing today are
`IPR2025-00945, 946, 947, and 948 and 949.
` Do you understand that?
`A. Right. They are different.
`Q. There's five different IPRs that we are going to
`be discussing today, correct?
`A. I will assume that's correct, but I don't know
`for a fact that there's five.
`Q. Okay.
`A. I mean, there's four patents.
`Q. There's four patents. Either way, all of your
`opinions that you have provided in the IPRs are
`contained in the Exhibit 1009 we have in front of you,
`correct?
`A. Correct.
`Q. Okay. So you understand the questions I'm
`asking you today are going to go to your opinions to all
`of the patents, correct?
`A. Correct.
`Q. All right. Thank you.
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` And you understand the transcript is going to be
`submitted in all of the IPRs that you submitted a
`declaration, correct?
`A. I don't know that for a fact.
`Q. Okay. No problem.
` So, Dr. Peroutka, you mentioned that you did
`some research in nausea and vomiting in the -- I think
`you said 1980s. Is that right?
`A. Yes.
`Q. Okay. Maybe if you can just give me a little
`bit of background and explain to me if you can your
`background on nausea and vomiting as it relates to
`chemotherapy.
`A. Yes. As I was a medical student and MP Ph.D.
`pharmacology in John Hopkins and in my medical
`rotations, I noticed that there -- and also I should
`add, I was a medical intern here at Stanford, and I did
`rotations on oncology. I was getting a Ph.D. in
`pharmacology previously, and I noticed that the
`chemotherapy-induced nausea and vomiting was pretty
`severe then. I mean, it was to the point that patients
`would actually sometimes not take more chemo because of
`the side effects of nausea and vomiting.
` And I was working on different, what's called,
`biogenic immune receptors, some of which like dopamine
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`at the time, had some evidence of antiemetic activity,
`anti-nausea drugs like Mermerinic (ph) drugs, et cetera.
`So I had this hypothesis that I wrote with my Ph.D.
`mentor, Solomon Snyder, that was published in The
`Lancet, talking about combinations of antiemetics is
`probably what we needed, that nausea and vomiting from
`chemo was probably multifactorial, multiple biological
`pathways, and that clearly the drugs we had at the time
`in single use were not very effective.
` So I organized a study at Johns Hopkins with the
`oncology department, Dr. David Ettinger was the
`oncologist that help me, and his team, and we did a
`small study doing different combinations and published
`that at the ASCO, American Society of Clinical Oncology,
`meetings. Unfortunately, we didn't get great success.
`Q. Okay.
`A. The combos, they helped a little, but it was
`still pretty bad.
` So then after that, my chemo-induced work
`decreased. I did a little more actually here at
`Stanford. I screened drugs, chemo drugs, at these
`receptors to see maybe that's where they were acting,
`you know, just -- and they didn't -- they didn't do
`anything. They are acting in a different location.
`That caused the nausea in different mechanism.
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` And then I worked on nausea and vomiting not
`specifically related to chemo, but migraine. And 5HT3
`drugs were very hot back then. There was a hypothesis
`that 5HT3 drugs, antagonists, should work in migraine
`because they worked in nausea, well, vomiting in
`ferrets. That was the model that of a ferret vomiting.
`So I was working on it in that sense. I actually had a
`grant from NASA down the street here, NASA AMES for
`space sickness, that -- when you talk to astronauts,
`this was a big problem. They were treating them with
`dex -- dex -- amphetamines, dexedrine and scop --
` THE REPORTER: Doctor, I have to ask you to slow
`down, especially on the technical.
` THE DEPONENT: The names, yeah, dexedrine and
`scopolamine.
` And that, you know, it was very memorable
`speaking to an astronaut in Houston at NASA, where he
`said, if you look out of the spaceship down to Earth,
`but the Earth is up, you can just vomit. So I did a
`research grant on that.
` And then through early 2000s, I was at Johnson &
`Johnson, where we were developing a pain molecule. I
`was in the pain group called tapentadol that was
`supposedly to give less nausea and vomiting. Opioids
`induced nausea and vomiting from the chemo perspective,
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`mostly in the '80s, but nausea and vomiting through --
`well, my last job relevant to that was a company called
`Zogenix, where we were developing a pure hydrocodone
`whose major side effect was nausea, vomiting, and also a
`migraine drug that stopped nausea and vomiting.
` So in terms of pharmacology, controlling,
`managing nausea and vomiting, I have done a pretty broad
`base.
`BY MR. ASHKENAZI:
`Q. Okay. So let me just ask a few questions, then,
`specific to -- to your work. I think you've given a
`lot. I'm going to try to break it down into some small
`pieces, if we can.
` So your research into chemotherapy-induced
`nausea and vomiting, that was in the 1980s. Is that
`correct?
`A. Correct.
`Q. Okay. And you've never treated patients with a
`5HT3 antagonist or NK-1 receptor antagonist for
`chemotherapy-induced nausea and vomiting, correct?
` MR. TORCZON: Objection. Relevance.
` THE DEPONENT: Correct.
`BY MR. ASHKENAZI:
`Q. Okay. Meaning you left the practice of medicine
`and went into research sometime in the -- around 1990.
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`Is that accurate?
` MR. TORCZON: Same objection.
` MR. ASHKENAZI: And I apologize. You also need
`to give your counsel an opportunity to object, just so
`that the court reporter can, you know, get everything
`down right.
`BY MR. ASHKENAZI:
`Q. Okay. So you left the practice of medicine
`sometime around 1990. Is that accurate?
` MR. TORCZON: Same objection.
` THE DEPONENT: Not exactly. I kept my medical
`license and I use it. I was chief medical officer of
`numerous companies. I had to be the ba -- an adverse
`event reporting, clinical trial review of data. So I
`didn't practice in terms of prescription.
` I worked in studies in the '90s, and even in the
`2000s that required an M.D., and I just put my
`license -- medical license to practice in retirement
`phase in California. They allow us to keep the license.
`I'm still on the books, and I can activate it at any
`time without further testing or continuing education
`type proof. But it's an active license that's in,
`quote, retirement as of last year.
`BY MR. ASHKENAZI:
`Q. Okay. Let me just take a couple small pieces
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`there.
` You have not prescribed any medications yourself
`since 1990, correct?
` MR. TORCZON: Same objection.
` THE DEPONENT: I'm thinking I did do a migraine
`study with an approved drug, which I can't remember
`whether I wrote the prescription, but it was part of the
`study. But I did give medications, approved products --
` MR. ASHKENAZI: Okay.
` THE DEPONENT: -- to patients in the late '90s.
`BY MR. ASHKENAZI:
`Q. You haven't prescribed a 5HT3 antagonist or
`treating CINV, correct?
` MR. TORCZON: Objection. Relevance.
` THE DEPONENT: Correct.
`BY MR. ASHKENAZI:
`Q. And you have not prescribed an NK-1 receptor
`antagonist for treating CINV, correct?
` MR. TORCZON: Same objection.
` THE DEPONENT: Correct.
`BY MR. ASHKENAZI:
`Q. And when I say CINV, you understand I mean
`chemotherapy-induced nausea and vomiting, correct?
`A. Correct.
`Q. Okay. You did practice and you focused on
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`treating patients for about six years between graduating
`in 1990. Is that accurate?
` MR. TORCZON: Same objection. Form.
` THE DEPONENT: Ten years, I would say.
`BY MR. ASHKENAZI:
`Q. Ten years?
`A. I was an intern one year, resident and fellow
`three years, and faculty six years.
`Q. Okay. Great. And that ended in 1990, right?
`A. Yes.
`Q. Now, you then went into industry. Is that
`accurate?
`A. (Moves head up and down.)
`Q. And would you say that your --
`A. Correct.
`Q. I'm sorry. Would you say that your practice --
`I think you mentioned this earlier -- focused on
`migraine medications, pain medications, and stroke? Is
`that -- is that right?
` MR. TORCZON: Objection. Misstates.
` THE DEPONENT: I did transiently in different
`times focus on those things. I have spent 12 years
`since 2008, total, in the CRO world, where we looked at
`all sorts of neuro in -- neuropsychiatric indications.
`///
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`BY MR. ASHKENAZI:
`Q. Okay. So from 2008 until today, you have worked
`in the CRO world. Is that accurate?
`A. Not completely, but 12 of the whatever years
`it's been.
`Q. Okay. Have you done any research in -- into
`drugs after the year 2000 -- withdrawn.
` Let me start again.
` After the year 2000, have you done any research
`on drugs for treating chemotherapy-induced nausea or
`vomiting?
`A. I haven't done any studies, but I have reviewed
`studies on the topic.
`Q. When you say you have reviewed studies, you have
`read literature. Is that accurate?
`A. And also in the CRO world, we will get RFPs,
`requests for proposals, and sponsors will bring us a
`protocol and say, can you do this study, and my job as
`the head of the neuroscience group was to review and
`comment on whether that was, you know, appropriately
`designed.
`Q. Okay. So from 2000 until today, you haven't
`done any research into treatments for
`chemotherapy-induced nausea or vomiting, but you have
`reviewed proposals for protocols to study that topic.
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`Is that correct?
` MR. TORCZON: Objection. Form. Asked and
`answered.
` THE DEPONENT: I believe I had. I have reviewed
`a thousand proposals in 12 years, roughly, and so I --
`I -- we have -- I definitely know I've seen proposals,
`but, you know, one is confidential. I can't disclose if
`I knew, but I would have to go and check the number
`exactly.
`BY MR. ASHKENAZI:
`Q. Okay. And only you would -- you would be
`focused on there is just to see if the study design was
`accurate, correct? Is -- withdrawn.
` Your focus was to see if the study design or the
`protocol was proper. Is that right?
` MR. TORCZON: Objection. Relevance.
` THE DEPONENT: I wouldn't say proper. I would
`say my role was to suggest what -- what could optimize
`it.
`BY MR. ASHKENAZI:
`Q. Okay. Now, part of study protocols is to look
`at -- part of evaluating a study design is to make sure
`that the study could provide you with information to
`determine if the drug has an effect or not, correct?
` MR. TORCZON: Objection. Relevance.
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`Foundation.
` THE DEPONENT: Correct.
`BY MR. ASHKENAZI:
`Q. Okay. And as someone who is involved in the
`design of study protocols, you are also familiar with
`the statistics that are involved, correct?
`A. Correct.
`Q. Okay. In general, what's the purpose of
`statistics in a study design?
` MR. TORCZON: Objection. Scope.
`BY MR. ASHKENAZI:
`Q. And --
` MR. TORCZON: I'm sorry.
` MR. ASHKENAZI: Withdrawn. Let me ask the
`question a little differently.
`BY MR. ASHKENAZI:
`Q. Statistics help us figure out if an effect we
`are seeing from a clinical study is actually real or if
`it could be due to chance, correct?
` MR. TORCZON: Objection. Form.
` THE DEPONENT: Well, I didn't opine on that
`matter, so should I -- I am -- I mean, that's not in my
`deck.
` MR. TORCZON: You can go ahead and answer the
`question.
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` THE DEPONENT: So statistics are, as you said,
`Mr. Ashkenazi, designed to show the likelihood that the
`effect that is observed is, quote, real. And
`historically, less than .05 is considered a 1-in-20
`chance. That's what the 05 is, 5 percent chance. That
`this is just, you know, flipping a penny 10 times and
`getting 10 heads. It can happen and it's real, but it's
`not the average. So the FDA has mandated and they have
`recently changed their mind, but certainly back then
`that you needed two studies powered, meaning
`statistically designed, with X number of patients with X
`or Y expectation of this success. You have to predefine
`what you think is going to happen, and then you have to
`show that within the boundaries of the P less than 05
`twice and independently.
`BY MR. ASHKENAZI:
`Q. Okay. So scientists generally -- withdrawn.
` If I use the term "person of ordinary skill in
`the art," you will understand I'm referring to what you
`have discussed in your declaration, correct?
`A. Yes.
`Q. Okay. And if I use POSA, P-O-S-A, you will
`understand that to mean person of ordinary skill in the
`art?
`A. Yes.
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`Q. Okay. Great. It makes it a little easier for
`us.
` So if I understand you correctly, statistics are
`an important part of any study design, correct?
` MR. TORCZON: Objection. Misstates.
` THE DEPONENT: Yes, especially at the primary
`endpoint.
`BY MR. ASHKENAZI:
`Q. Okay. And scientists understand that in order
`to determine whether an effect is real or potentially
`due to random chance, we use statistics to make that
`determination, correct?
` MR. TORCZON: Objection. Scope.
` THE DEPONENT: Yes. But it varies on the
`importance based on the primary versus secondary versus
`exploratory endpoints.
`BY MR. ASHKENAZI:
`Q. Okay. And it'S generally accepted that a P
`value of less than .05 is -- would allow someone to make
`a determination of statistical significance, right?
`A. Yes.
`Q. Okay. Meaning if the P value is greater than
`.05, then it's generally understood by a POSA that
`whatever effect you're seeing is not statistically
`significant?
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` MR. TORCZON: Is there -- is that a -- then
`objection. I'm sorry. Let's track that.
` THE DEPONENT: Yeah.
` MR. TORCZON: Give me a second. Object. I lost
`track what the objection was. I'm sorry.
` THE DEPONENT: Would you mind repeating it?
` MR. TORCZON: Scope.
` THE DEPONENT: Because now I've lost the train,
`too.
` MR. TORCZON: Objection. Scope was going to be
`the objection.
`BY MR. ASHKENAZI:
`Q. If a P value is greater than .05, then it would
`generally be understood by a POSA that the effect or the
`difference in numerical values that you are seeing in
`the study are not statistically significant, correct?
` MR. TORCZON: Objection. Asked and answered.
` THE DEPONENT: Correct. At a statistical level.
`BY MR. ASHKENAZI:
`Q. Yeah. And the FDA and scientists and POSAs
`generally understand that statistically -- statistical
`significance is relevant for making a determination on
`whether an effect is real, correct?
` MR. TORCZON: Objection. Scope.
` THE DEPONENT: For the primary endpoint.
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`BY MR. ASHKENAZI:
`Q. And you will agree with me that statistics are
`not only used in clinical trials, correct?
`A. Correct.
`Q. And people conduct scientific analyses all the
`time and use -- withdrawn.
` I'm sorry. I got computer problems here.
` And in general in scientific literature,
`scientists use the value point P less than .05 to make
`the determination of statistical significance for
`effects in a study, correct?
` MR. TORCZON: Objection. Scope.
` THE DEPONENT: Correct.
`BY MR. ASHKENAZI:
`Q. Have you yourself used for non-primary endpoints
`the value -- the P value of less than .05 to make a
`determination of statistical significance?
` MR. TORCZON: Objection. Scope.
` THE DEPONENT: I have recommended it to
`sponsors.
`BY MR. ASHKENAZI:
`Q. Okay. In other words, in general, a POSA would
`understand that when you are looking at any data, in
`order to make an under -- to make -- to be able to
`conclude that the effect is real, as opposed to
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`potentially by chance, you use a P value of less than
`.05, correct?
` MR. TORCZON: Objection. Misstates.
` THE DEPONENT: I don't. I think in general, P05
`is a regulatory requirement. But if you want
`directionality in a study, if you want to do a phase 2
`small study, P equals 10 is a 90 percent chance it's
`real. So I've -- I -- myself, I have recommended to
`sponsors that for directionality purposes in a small
`study, you can accept a lesser P value.
`BY MR. ASHKENAZI:
`Q. When you say "directionality," you mean a
`possibility that something may occur?
`A. The possib