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` THE UNITED STATES PATENT AND TRADEMARK OFFICE
` _____________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _____________________
` COALITION FOR AFFORDABLE DRUGS VIII LLC
` Petitioner
` v.
` THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
` Patent Owner
` _____________________
` Case IPR2015-01836
` U.S. Pat. No. 7,932,268
` ________________________
`
`
` VIDEO DEPOSITION OF RANDALL M. ZUSMAN, M.D.
` Boston, Massachusetts
` Thursday, May 19, 2016
`
`Reported by: Dana Welch, CSR, RPR, CRR, CLR
`Job No: 107336
`
`TSG Reporting - Worldwide 877-702-9580
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`PENN EX. 2022
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`Page 1
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` THE UNITED STATES PATENT AND TRADEMARK OFFICE
` _____________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _____________________
` COALITION FOR AFFORDABLE DRUGS VIII LLC
` Petitioner
` v.
` THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
` Patent Owner
` _____________________
` Case IPR2015-01836
` U.S. Pat. No. 7,932,268
` ________________________
`
`
` VIDEO DEPOSITION OF RANDALL M. ZUSMAN, M.D.
` Boston, Massachusetts
` Thursday, May 19, 2016
`
`Reported by: Dana Welch, CSR, RPR, CRR, CLR
`Job No: 107336
`
`TSG Reporting - Worldwide 877-702-9580
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`Page 2
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` May 19, 2016
` 9:58 a.m.
`
` Video deposition of RANDALL ZUSMAN, M.D.,
`held at the offices of GOODWIN PROCTER, Exchange
`Place, 53 State Street, Boston, Massachusetts,
`pursuant to Notice, before Dana Welch, a Certified
`Shorthand Reporter, Registered Professional
`Reporter, Certified LiveNote Reporter, a Certified
`Realtime Reporter, and a Notary Public of
`the Commonwealth of Massachusetts.
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`A P P E A R A N C E S:
`GONSALVES LAW FIRM
`Attorneys for Coalition for Affordable Drugs
`2216 Beacon Lane
`Falls Church, VA 22043
`BY: GREGORY GONSALVES, ESQ.
`
`GOODWIN PROCTER
`Attorneys for Trustees of the University
`of Pennsylvania
`53 State Street
`Boston, MA 02109
`BY: NICHOLAS MITROKOSTAS, ESQ.
`
`--- appearances continue ---
`
`TSG Reporting - Worldwide 877-702-9580
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`APPEARANCES (continued)
`GOODWIN PROCTER
`901 New York Avenue, N.W.
`Washington, D.C. 20001
`BY: KRUPA PARIKH, ESQ.
`
`- and -
`WILMERHALE
`60 State Street
`Boston, MA 02109
`BY: KEVIN PRUSSIA, ESQ.
`
`Also present: Darryn Carroll, Videographer
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` ZUSMAN
` P R O C E E D I N G S
` THE VIDEOGRAPHER: This is the start of
` tape number one of the videotaped deposition of
` Dr. Randall Zusman in the United States Patent and
` Trademark Office before the Patent Trial and Appeal
` Board, Coalition for Affordable Drug VII LLC versus
` the Trustees of the University of Pennsylvania,
` case IPR 2015-01836, United States Patent Number
` 7,932,268.
` This deposition is being held at 53 State
` Street, Boston, Massachusetts on May 19th, 2016 at
` approximately 9:59 a.m.
` My name is Darryn Carroll from TSG
` Reporting and I'm the legal video specialist. The
` court reporter is Dana Welch, in association with
` TSG Reporting.
` Will counsel please introduce yourself.
` MR. MITROKOSTAS: Nicholas Mitrokostas of
` Goodwin Procter on behalf of patent owner, the
` Trustees of the University of Pennsylvania. And
` with me today, also from Goodwin Procter, is
` Krupa Parikh.
` MR. PRUSSIA: Kevin Prussia from
` WilmerHale.
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` ZUSMAN
` DR. GONSALVES: My name is Dr. Gregory
` Gonsalves. I'm representing the petitioner.
` THE VIDEOGRAPHER: Will the court reporter
` please swear in the witness.
` RANDALL M. ZUSMAN, M.D., sworn
` EXAMINATION
` BY MR. MITROKOSTAS:
` Q. Good morning, Dr. Zusman.
` A. Good morning.
` MR. MITROKOSTAS: And Greg, just for the
` record, I think the deposition is being taken in
` addition to IPR number 2015-01836, also in
` 2015-01835.
` DR. GONSALVES: Right, that's my
` understanding as well.
` MR. MITROKOSTAS: Okay.
` Q. Dr. Zusman, have you been deposed before?
` A. Yes, I have.
` Q. Approximately how many times?
` A. I would say probably ten, perhaps as many
` as 15.
` Q. When was the last time that you were
` deposed?
` A. It was two months ago.
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` Q. So you're familiar generally with how a
` deposition proceeds, correct?
` A. Yes, I believe I am, right.
` Q. I won't repeat the instructions that we
` typically give at the start of a deposition other
` than to say that if for some reason one of my
` questions is unclear, let me know and I can clarify
` it for you.
` A. Thank you. I understand.
` Q. Is there any reason why you cannot give
` truthful testimony here today?
` A. No, there is not.
` Q. You mentioned that you've been deposed 10
` to 15 times. Approximately how many of those times
` related to patent in litigation or patent disputes?
` A. I believe this will be the fifth.
` Q. And approximately how many times have you
` been deposed in a proceeding before the Patent
` Trial and Appeal Board?
` A. This would be the first.
` Q. Did the other five patent proceedings in
` which you provided deposition testimony involve
` pharmaceutical patents?
` A. Yes, they did.
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` Q. Do you recall what drugs those patent
` proceedings related to?
` A. Yes. The first one was fenofibrate; the
` second drug was ranolazine; the third was
` nicardipine; the fourth was dronedarone; and the
` fifth was prasugrel. Yes, those are the five.
` Q. Now, in the fenofibrate litigation, on
` behalf of which party did you provide testimony?
` A. Plaintiff -- I'm sorry. Defendant. Those
` who are challenging the patent.
` Q. Do you recall, it was a generic drug
` company?
` A. That's correct.
` Q. Do you recall the name of that generic
` drug company?
` A. I don't.
` Q. Okay. And did you testify at trial in the
` fenofibrate litigation?
` A. No. It was settled one minute before the
` trial was to begin.
` Q. Now, did that involve the 200-milligram
` capsule formulation of fenofibrate or the
` 154-milligram tablet formulation of fenofibrate, if
` you recall?
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` A. I don't recall.
` Q. In the ranolazine litigation --
` A. Correct.
` Q. -- on behalf of which party did you
` provide deposition testimony?
` A. Again, it was on behalf of the defendant.
` Q. So in the ranolazine patent litigation,
` you also testified on behalf of the generic patent
` challenger?
` A. That's correct.
` Q. Did you provide trial testimony in the
` ranolazine litigation?
` A. Yes, I did.
` Q. Do you recall before which court that was
` proceeding?
` A. It was in the New York Federal -- the
` Newark Federal court, Judge Salas presiding.
` Q. In the nicardipine matter, did you -- on
` behalf of which party were you testifying?
` A. Again, it was on behalf of the defendant.
` Q. So in the nicardipine patent litigation,
` you also testified on behalf of the generic patent
` challenger; is that correct?
` A. That's correct.
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` ZUSMAN
` Q. Did you provide trial testimony in that
` case?
` A. No, I did not. It was settled two days
` before the trial was to begin.
` Q. In the donetazone [phonetic] litigation,
` on behalf of which party did you provide testimony
` social security?
` A. It's dronedarone --
` Q. Okay.
` A. -- or Multaq is the commercial name.
` Again, on behalf of the defendant.
` Q. So in the dronedarone patent litigation --
` A. Yes.
` Q. -- you also testified on behalf of the
` generic patent challenger; is that correct?
` A. That's correct.
` Q. And I believe the last litigation you
` mentioned in which you provided testimony that
` related to patents was prasugrel?
` A. Prasugrel, right.
` Q. And in the prasugrel patent litigation, on
` behalf of which party did you provide testimony?
` A. Again, the defendant.
` Q. So in the prasugrel patent litigation, you
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` ZUSMAN
` also testified on behalf of the generic patent
` challenger; is that correct?
` A. That's correct.
` Q. Okay. So in all of the patent litigations
` or proceedings in which you've offered testimony to
` date, you've provided that testimony on behalf of
` the patent challenger; is that correct?
` A. That is correct.
` Q. Now you mentioned that you had also
` testified another ten times by deposition, correct?
` A. Or in court.
` Q. Or in court.
` And what did those matters generally
` relate to?
` A. So the majority of them were medical
` malpractice cases either here in Massachusetts or
` in other states. And one of my trial testimonies
` involved product liability.
` Q. With respect to what product did you
` testify in -- were you testifying in that product
` liability matter as an expert witness?
` A. Yes, I was.
` Q. And with respect to that product liability
` matter, what was the product at issue?
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` A. It was a decongestant. I want to say
` pseudoephedrine but it wasn't pseudoephedrine. It
` was one of the cold decongestant medications used
` for upper respiratory infections, for example.
` Q. And in the medical malpractice cases in
` which you've testified, were you testifying as an
` expert witness?
` A. Yes, I was. I have actually once
` testified as a treating physician on behalf of my
` patient.
` Q. Did that testimony you provided on behalf
` of your patient relate to any particular drug?
` A. No. It had to do with a procedure,
` informed consent, and the patient's expectation of
` the benefits and risk of that procedure.
` Q. Who retained you for this proceeding?
` A. I was initially contacted by the firm of
` Rakoczy and Molino, Mazzochi and colleagues in
` Chicago.
` Q. Do you recall who from the Rakoczy law
` firm contacted you?
` A. I think I was initially called by
` Jeff Burns.
` Q. Have you worked with the Rakoczy firm on
`
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` other litigations?
` A. Yes. They were the firm involved with the
` dronedarone litigation. And they were also for
` part of the time involved with the dronedarone
` litigation. Did I say dronedarone? The first was
` ranolazine, I'm sorry. Ranolazine was the first
` case; dronedarone was the second case.
` Q. Are you working with the Rakoczy law firm
` on any other patent litigation matter at present?
` A. No.
` Q. Have you done any prior work with the
` Gonsalves law firm?
` A. No. This is the first time I've worked
` with Dr. Gonsalves.
` Q. What about the law firm McNeely, Hare &
` War, are you familiar with that law firm?
` A. I'm not, no. I don't recognize that name.
` Q. Are you currently retained by anyone else
` in connection with the patents that are at issue in
` this IPR proceeding?
` A. No, I don't believe so.
` Q. You testified that the Rakoczy law firm
` reached out to you about this matter. Do you
` recall what you were asked to do when you were
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` first approached by them?
` A. To review the patents, to review some of
` the literature with regard to this particular
` product, and to review some of the literature
` regarding lopidamide [phoentic] in particular, and
` MTP inhibitors in general.
` Q. One of the references that you testify
` about in your declaration is authored by an
` individual named Chang.
` A. Yes.
` Q. Is that correct?
` A. Yes.
` Q. And so if I refer to it as the Chang
` reference, you'll understand what I'm referring to,
` correct?
` A. Absolutely. Yes, I will.
` Q. Is the Chang reference one of the
` references that the Rakoczy law firm provided to
` you when they retained you?
` A. Yes. I believe that that was among the
` paperwork that I received in my initial literature
` review.
` Q. Another one of the references about which
` you're testifying in your declaration is a Pink
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` Sheet from 2004?
` A. Right, the Pink Sheet, yeah.
` Q. So if I refer to it as the Pink Sheet
` 2004, do you understand what I'm referring to?
` A. Yes, I do.
` Q. Okay. And is the Pink Sheet 2004 a
` reference that the Rakoczy law firm provided to you
` when they retained you for this case?
` A. It was, I believe, included in the
` materials I was sent.
` Q. Another one of the references about which
` you testify in your declaration is a PPD
` presentation. I believe you refer to it as the
` Stein 2004 presentation; is that correct?
` A. Yes.
` Q. So if I refer to it as the Stein 2004
` presentation, do you understand what I'm referring
` to?
` A. Yes, I will.
` Q. Okay. And is the Stein 2004 presentation
` also one of the references that the Rakoczy law
` firm provided to you after you were retained for
` this proceeding?
` A. Yes. It was among the materials that was
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` ZUSMAN
` sent to me.
` Q. Dr. Zusman, I've handed you what's marked
` at the bottom as CFAD Exhibit 1002.
` Do you have a copy of that document in
` front of you?
` A. Yes, I do.
` Q. Okay. And do you see that on the cover
` page of CFAD Exhibit 1002 it identifies U.S. Patent
` Number 8,618,135 to Rader?
` A. Yes, it does.
` Q. Do you recognize Exhibit 1002 as the
` declaration that you prepared with respect to the
` IPR proceeding for the '135 patent?
` A. Yes. I recognize it to be my declaration.
` Q. And Dr. Zusman, I've now handed you CFAD
` Exhibit 1002 that references on the cover page U.S.
` Patent Number 7,932,268.
` Do you have that in front of you?
` A. Yes, I do.
` Q. And do you recognize this to be the
` declaration that you submitted in the IPR
` proceeding relating to U.S. Patent Number
` 7,932,268?
` A. Yes, I do.
`
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` Q. Okay. Now, if I use the Exhibit 1002 with
` respect to the '268 patent -- well, let's back up
` for a second. Can you confirm that there are no
` sort of material differences between your
` declaration submitted with respect to the '268
` patent and the '135 patent in these IPR
` proceedings?
` DR. GONSALVES: Objection.
` A. Yes. I believe I can confirm that that is
` the case.
` Q. And so to the extent I ask you questions
` focused on the Exhibit 1002 with respect to the
` '268 patent, would those -- would your answers to
` those questions apply equally to your declaration
` submitted in the IPR proceeding relating to the
` '135 patent?
` DR. GONSALVES: Objection.
` A. That is my understanding.
` Q. So I'm going to generally ask you
` questions today about your Exhibit 1002 submitted
` in the IPR proceeding relating to the '268 patent
` just for simplicity and we'll refer to the other
` declaration to the extent necessary.
` A. I understand.
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` Q. If you could please turn to page little vi
` and little vii of your Exhibit 1002.
` A. Okay.
` Q. Sorry. Roman numeral little vi and Roman
` numeral little vii.
` A. Oh, I'm sorry.
` Q. Which is the Table of Exhibits.
` A. Yes.
` Q. Were all of the references identified in
` the Table of Exhibits on pages little Roman
` numeral vi and little Roman numeral vii provided to
` you by the attorneys for the Coalition for
` Affordable Drugs?
` A. The hard copies were. Some of these
` documents I probably was already aware of and had
` copies of. For example, 1021 and 1022 are
` documents that I have in -- for example, in my
` office or comparable documents. And I had
` previously seen, I'm not sure if I had a copy in my
` office of 1031, which is the third report of the
` National Cholesterol Education Program.
` Q. But other than the documents that you just
` referenced and your curriculum vitae, 1027, the
` remainder of the documents in this Table of
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` Exhibits were provided to you by attorneys for the
` Coalition for Affordable Drugs, correct?
` A. Yes, they were.
` Q. Now one of the exhibits identified here is
` the declaration of Michael Mayersohn, 1003.
` Do you see that?
` A. I do.
` Q. Do you know Dr. Mayersohn?
` A. I do.
` Q. How do you know Dr. Mayersohn?
` A. He was also involved in the ranolazine
` litigation, and so we met during the course of the
` trial.
` Q. So Dr. Mayersohn worked with you on the
` ranolazine litigation on behalf of Rakoczy firm; is
` that correct?
` A. Well, he was another one of the witnesses.
` Because we have different areas of expertise, I
` wouldn't say we necessarily worked together, but we
` met each other, talked, were involved in the
` litigation.
` Q. Other than your work on that litigation,
` have you ever encountered Dr. Mayersohn in a
` professional setting?
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` A. No.
` Oh, I've remembered the name of the drug
` in the prior proceeding, the product litigation.
` Q. Oh, what was it?
` A. It's phenylpropanolamine or PPA, as it was
` commonly known.
` Q. So the record is clear, the name -- the
` drug that was the subject of the product liability
` litigation in which you testified as an expert was
` phenylpropylene [phonetic]?
` A. Phenylpropanolamine.
` Q. Great. Thank you?
` A. Exactly.
` Q. Dr. Zusman, I'm handing you Exhibit 1028
` of the IPR proceeding relating to the '268 patent.
` Do you see that?
` A. Yes.
` Q. It is a document entitled "Documents
` Considered by Dr. Randall M. Zusman, M.D."; is that
` correct?
` A. Yes.
` Q. And it identifies 24 documents; is that
` correct?
` A. It does.
`
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` Q. Other than the 24 documents listed in
` Exhibit 1028, did you consider anything else in
` preparing your declaration?
` A. I don't believe so. No, I did not.
` Q. Did you draft the declaration of Exhibit
` 1002?
` A. I didn't do the actual typing, but I was
` the author, in essence, of the declaration.
` Q. And approximately --
` MR. MITROKOSTAS: Strike that.
` Q. Did you meet with attorneys in preparing
` the declaration, Exhibit 1002?
` A. We didn't meet physically. We talked on
` the phone.
` Q. With which attorneys did you work in order
` to prepare your declaration, Exhibit 1002?
` A. Well, I know that Mr. Burns was involved,
` and I'm confident there were others from his firm.
` But he's the one that I remember.
` Q. Okay. So you worked with the attorneys
` from the Rakoczy law firm to prepare the
` declaration, Exhibit 1002?
` A. That's correct.
` Q. Okay. Did you talk with anyone from the
`
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` Coalition for Affordable Drugs in preparing your
` declaration, Exhibit 1002?
` A. No, I did not.
` Q. And other than counsel for the Coalition
` for Affordable Drugs, did anyone else participate
` or assist in the preparation of your declaration?
` A. No.
` Q. Did you prepare for your deposition today?
` A. I did.
` Q. What did you do to prepare for your
` deposition, Dr. Zusman?
` A. I re-read a number of the materials that
` have been listed here. I met with Dr. Gonsalves
` yesterday, and I read the -- not in detail, but I
` read in detail Dr. Mayersohn's deposition
` transcript.
` Q. For how long did you meet with
` Dr. Gonsalves?
` A. So a total of three hours.
` Q. Did you have any meetings with
` Dr. Gonsalves prior to yesterday to prepare for
` your deposition?
` A. Only on the telephone.
` Q. Approximately how many times did you speak
`
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` on the telephone?
` A. I think it was twice.
` Q. And approximately how long were each of
` those telephone discussions?
` A. About an hour or so.
` Q. Did you speak with anyone at the Rakoczy
` law firm to prepare for your deposition today?
` A. No, I did not.
` Q. When was the last time you spoke with
` anyone at the Rakoczy law firm with regard to these
` IPR proceedings?
` A. I believe it would have been immediately
` following the final draft of my declaration and my
` signing the document. That would have been the
` last time that I was in contact with them.
` Q. So it would have been last summer,
` approximately?
` A. Yeah. I don't remember exactly the date
` when I finally signed.
` Is this a signed copy?
` Q. It is. On page 127 of your exhibit.
` A. Yep. So it would have been last August.
` Q. Okay. Have you ever spoken to
` Dr. Mayersohn with regard to the subject matter of
`
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` these IPR proceedings?
` A. No, I have not.
` Q. Okay. And you didn't speak with him,
` obviously, in preparation for your deposition
` today?
` A. No, I did not.
` Q. Have you ever designed a clinical study,
` Dr. Zusman?
` A. Yes, I have.
` Q. Approximately how many times?
` A. Well, when you say "designed" -- so I have
` participated in many and been involved in
` discussions about how the trial should be
` conducted; timing, drug dosage, the data that
` should be acquired, and how that data should be
` acquired. I've been involved, for example, as part
` of the trial coordinating committee, for example;
` in which case even before you get involved in the
` recruitment of investigators, you design the trial
` and establish its purposes and goals. And then
` I've been involved in some trials conducted at the
` Massachusetts General Hospital as a single-center
` trial where I was intimately involved in the
` development of the study design, the data
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` ZUSMAN
` acquisition, its analysis, and then its final
` publication. Not all of those trials involved
` drugs.
` Q. Your principal involvement in clinical
` trials has been focused as an investigator,
` however, right?
` DR. GONSALVES: Objection.
` A. "Principal" meaning majority?
` Q. Correct.
` A. Yes, in the majority of the trials, I've
` been a study site investigator.
` Q. And typically, as a study site
` investigator, you receive protocol that's already
` been developed from the company that's sponsoring
` the trial, correct?
` DR. GONSALVES: Objection.
` A. The usual sequence is to be recruited to
` participate, to receive some preliminary materials.
` Often there's an investigators' meeting where
` people go through the protocol and ideas are
` exchanged with regard to changes in the protocol
` that might improve it; or problems with the
` protocol that may make it difficult to recruit
` patients or acquire the data in a meaningful and
`
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` accurate fashion. And then a final protocol is
` composed, which is then submitted by myself and
` other investigators to the Institutional Review
` Board before patient recruitment begins.
` Q. Typically, by the time a study site
` investigator is involved in the clinical trial,
` there's been an investigator's brochure that's been
` prepared, correct?
` DR. GONSALVES: Objection.
` A. When it's a pharmaceutically sponsored
` trial, typically there would be a brochure that's
` developed. And that brochure, of course, describes
` the many characteristics, important characteristics
` of the drug to be studied.
` Q. Right.
` And at that point in time when the study
` site investigator is involved in a clinical trial,
` the company provides that study site investigator
` preclinical data and a plan with respect to the
` dosing of that product, correct, in the trial?
` A. That would be among the sort of
` information that I would expect. There's
` preclinical information. There's clinical
` experience. There's the earlier Phase 1 and
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` perhaps Phase 2 data that had been acquired. There
` would be the rationale for the trial that is to be
` conducted, some discussion of the statistical
` analysis that was to be conducted, and a timeline,
` a budget. Those are all the sorts of things that I
` might receive as a study site investigator.
` Q. Right.
` And so in company-sponsored clinical
` trials, typically the study site investigator
` becomes involved after the company has already
` decided what drug and in what dosing regimen
` they're going to test that drug in the clinical
` trial, right?
` DR. GONSALVES: Objection.
` A. I think often -- well, that information is
` obviously available in the initial protocol. That
` initial protocol, in my experience, is often
` modified before the final protocol is put in place.
` So the initial dosage regimen may, in fact, be
` modified; suggestions may be made to improve the
` dosing protocol according to the experience of the
` investigators in treating this patient population.
` Q. But in a company-sponsored clinical trial,
` the company has the final say with regard to the
`
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` drug and the dosing regimen that's going to be used
` in the study, correct?
` DR. GONSALVES: Objection.
` A. Ultimately a protocol is established and
` an investigator is given the option to participate
` or not. I have chosen in the past not to
` participate in clinical trials when I felt the
` protocol was inappropriate, unethical, or not in
` the best interest of my patients.
` So yes. The sponsor will ultimately
` decide on the protocol and the study design. The
` investigator then has the opportunity to
` participate or not.
` Q. Have you ever been involved in clinical
` trials that have failed to meet their endpoints?
` A. In terms of not being a positive study?
` Q. Correct.
` A. Or not being able to acquire sufficient
` patients?
` Q. No. In terms of the study being
` completed, but failing to demonstrate what they set
` out to demonstrate in that study.
` A. Yes.
` Q. What were some of those studies, if you
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` recall?
` A. Well, I would say the most notable would
` be our involvement in the study of torcetrapib, a
` drug developed by Pfizer that, as you probably
` know, was unfortunately associated with an
` increased mortality in the patient population
` receiving the drug. And that drug protocol was
` prematurely terminated for that reason.
` Q. Have you ever been involved in clinical
` trials on drugs where the subject drug never was
` approved by FDA?
` A. Well, torcetrapib would be one. I think
` D-Sotalol is a second. And I think that's it. I
` think every other drug I've studied was either
` already approved or was subsequently approved for
` the use in patient care.
` Q. You agree, do you not, that very few
` compounds that are studied at pharmaceutical
` companies ever reach the U.S. market, right?
` DR. GONSALVES: Objection.
` A. I'm aware that the pharmaceutical
` industry, you know, develops many, many more drugs
` than they eventually bring to sale and that those
` drugs, you know, will have failed for a host of
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` potential reasons.
` Q. Do you have any idea generally of what the
` success rate is of a clinical trial?
` DR. GONSALVES: Objection.
` A. Of a clinical trial?
` Q. Uh-huh.
` A. In terms of whether they achieve their
` endpoints or they are completed?
` Q. Correct. And whether they achieve their
` endpoints -- well, why don't we start with that.
` A. Well, certainly the majority of the
` clinical trials that I've participated in do, in
` fact, go to the end of the trial and a final
` statistical and/or clinical conclusion can be
` drawn. That may reflect the nature of my field or
` the care with which I choose the cl
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