`
`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`
`Date: June 22, 2022
`Case: Mylan Pharmaceuticals Inc. -v- Regeneron Pharmaceuticals, Inc. (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
`
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`Exhibit 2287
`Page 000 of 310
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`
`
`MYLAN PHARMACEUTICALS, :
` INC., :CASE:IPR2021-00881, -00880
` :
` v. :
`REGENERON PHARMACENTICALS, :
`INC. :
`----------------------------X
` ______________________________________
` IPR2021-00880, Patent No. 9,699,069 B2
` IPR2021-00881, Patent No. 9,254,338 B2
` ______________________________________
` Miami, Florida
` Wednesday, June 22, 2022
` CONFIDENTIAL
` VIDEOTAPED DEPOSITION
` THOMAS ALBINI, M.D.
` Wednesday, June 22, 2022
` 9:20 a.m. EST
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`2
`
`APPEARANCES:
`
` ON BEHALF OF THE PETITIONER MYLAN
` PHARMACEUTICALS:
` HEINZ J. SALMEN, ESQ.
` ABRAHAM VARON, ESQ.
` SCOTT BEAL, PH.D. Of Counsel
` RAKOCZY MOLINO MAZZOCHI SIWIK,
` LLP
` 6 W Hubbard Street, Suite 500
` Chicago, IL 60654
` 312) 527-2157
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`Exhibit 2287
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`3
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` ON BEHALF OF PATENT OWNER
` REGENERON PHARMACEUTICALS, INC.:
`
` DEBORAH FISHMAN, ESQ.
` ARNOLD & PORTER KAYE SCHOLER, LLP
` 3000 El Camino Real
` Palo Alto, CA 94306-3807
` (650) 319-4773
` and
` JEREMY COBB, ESQ.
` ARNOLD & PORTER KAYE SCHOLER, LLP
` 601 Massachusetts Avenue, NW
` Washington, DC 20001
` (202) 942-5000
`
`Ashley Taylor, Videographer
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`4
`
` INDEX
`WITNESS PAGE
`THOMAS ALBINI
`BY MS. FISHMAN 6
`
` EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1 Intracitreal Bevacizumab 16
` (Avastin) Therapy for
` Persistent Diffuse Diabetic
` Macular Edema
`Exhibit 2 Efficacy of q1.25 MG Versus 2.5 16
` MG Intravitreal Bevacizumab for
` Diabetic Macular Edema
`Exhibit 3 Petitioner's Reply 101
`Exhibit 4 Profile of Conbercept in the 130
` treatment of neovascular
` age-related macular
` degeneration
`Exhibit 5 Efficacy and Safety Trial of 139
` Conbercept Intravitreal
` Injection for Neovascular AMD
` (PANDA-1)
`Exhibit 6 Article entitled Emerging 232
` Concepts in Anti-VEGF Treatment
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`5
`
` P R O C E E D I N G S
` THE VIDEOGRAPHER: Here begins
`tape Number 1 in the videotaped
`deposition of Dr. Thomas Albini in the
`matter of Mylan Pharmaceuticals, Inc., v.
`Regeneron Pharmaceuticals, Inc.
` Today's date is Wednesday,
`June 22, 2022. The time on the video
`monitor is 9:20 a.m.
` The videographer today is Ashley
`Taylor, representing Planet Depos. This
`video deposition is taking place at 1633
`North Bayshore Drive, Miami, Florida.
` Would counsel please identify
`themselves for the record.
` (Attorneys stated their
` appearances for the record.)
` THE VIDEOGRAPHER: The court
`reporter today is Barbara Moore
`representing Planet Depos. Will the
`reporter please swear in the witness.
` ***********************
`
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`6
`
` THOMAS ALBINI,
`having been called as a witness } and having been
`first duly sworn, was examined and testified as
`follows:
`EXAMINATION BY
`MS. FISHMAN:
` Q. Good morning, Dr. Albini.
` A. Good morning.
` Q. You understand you're under oath
`today; correct?
` A. I do.
` Q. And is there any reason you can
`think of for why you cannot give complete and
`accurate testimony today?
` A. No.
` Q. And you had your deposition taken in
`this matter on January 20th. Do you recall that?
` A. Yes, I do.
` Q. Do you recall the general rules of
`the road for the deposition?
` A. It would be beneficial, I think, if
`we went over them again.
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`7
`
` Q. Okay. So I will pose a series of
`questions to you, and in response, unless your
`counsel interposes a privilege objection, you
`should answer my question.
` Do you understand that?
` A. Yes.
` Q. And if there's a question that is
`unclear to you or you do not understand, please ask
`me for clarification.
` Do you understand?
` A. Yes.
` Q. If you answer my question, I will
`assume that you've understood that, the question.
` Is that fair?
` A. Yes.
` Q. Okay. And if at any time you need a
`break, just please feel free to ask for one. And
`I'll try to take a break every hour, but I may not
`mind the time, so feel free to ask for a break when
`you need it. Okay?
` A. Thank you. Yes.
` Q. Okay.
`
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`8
`
` And to create a cleaner record, if you
`could allow me to finish my questions before you
`begin your answer, I would appreciate it, and I
`think your counsel would appreciate it as well.
` Do you understand that?
` A. Yes.
` Q. And similarly, because the court
`reporter is taking a transcript of the testimony
`here today, if you could wait -- excuse me. I will
`try to wait for you to finish your answers before
`asking my next question.
` Does that make sense?
` A. Yes.
` Q. Okay. I think that's all, so why
`don't we get started.
` What did you do to prepare to give
`testimony here today?
` A. I -- well, prepared my opinions as
`you have them and the replies for the two patents.
`I have reviewed that material. I have read and
`reviewed multiple depositions of other experts in
`this case. And I have discussed the case with
`
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`9
`
`counsel here. We met online for about three hours
`last week and yesterday in person for about four
`hours.
` Q. You mentioned that you reviewed the
`deposition testimony of certain of Regeneron's
`experts. Whose deposition testimony or whose
`deposition transcripts did you review?
` A. I'm not sure I can give you a
`complete list, because there were so many articles
`and so many depositions to be reviewed. But
`Dr. Delpriore, Dr. Brown, Dr. Doe come to mind.
` Q. And did you review the complete
`deposition transcripts for each of those experts?
` A. Yes.
` MR. SALMEN: Objection to form.
` BY MS. FISHMAN:
` Q. Now, I believe you testified at your
`prior deposition that about 30 percent of your
`practice is treating angiogenic eye disorders; is
`that correct?
` MR. SALMEN: Objection, form.
` THE WITNESS: That sounds
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`10
`
` reasonable.
` BY MS. FISHMAN:
` Q. What angiogenic eye disorders do you
`treat in your practice?
` A. Exudative macular degeneration,
`diabetic macular edema, retinal vein occlusion,
`choroidal neovascularization associated with other
`disorders, neovascular glaucoma. Those would be
`the most common forms.
` Q. When you say "exudative macular
`degeneration," is that another name for wet AMD?
` A. That's correct.
` Q. And is diabetic macular edema a
`feature or manifestation of diabetic retinopathy?
` A. Yes.
` Q. And when you say that you treat
`retinal vein occlusion in your practice, are you
`referring to the macular edema that's caused by
`retinal vein occlusion?
` A. That's correct.
` Q. And retinal vein occlusion would
`include both BRVO, or branch retinal vein
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`11
`
`occlusion, and CRVO, or central retinal vein
`occlusion; is that correct?
` A. That's correct.
` Q. And you treat both macular edema
`following branch retinal vein occlusion and central
`retinal vein occlusion in your practice; is that
`correct?
` A. That's correct.
` Q. Okay. You also mentioned that you
`treat choroidal neovascularization associated with
`angiogenic eye disorders. Is choroidal
`neovascularization associated with wet AMD?
` A. That's correct.
` Q. And then you also mentioned that you
`treat neovascular glaucoma. Is that a feature of
`wet AMD?
` A. No.
` Q. Is it a feature or complication of
`diabetic retinopathy?
` A. That's correct.
` Q. Can it also be a feature or
`complication of macular edema following retinal
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`12
`
`vein occlusion?
` A. That's correct.
` Q. And do you treat all of these
`disorders with anti-VEGF agents?
` MR. SALMEN: Objection to form.
` THE WITNESS: I do.
` BY MS. FISHMAN:
` Q. Has the angiogenic eye disorders
`that you treat in your practice changed much since
`2011?
` MR. SALMEN: Objection, form.
` THE WITNESS: I do not believe
` that there's any noticeable change in the
` patient presentations that I'm seeing.
` BY MS. FISHMAN:
` Q. And do you think that the mix of
`angiogenic eye disorder patients that you treat in
`your practice is fairly representative of the mix
`of angiogenic eye disorders that other
`ophthalmologists or retina specialists treat in
`their practice?
` MR. SALMEN: Objection, form,
`
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`13
`
`vague, scope.
` THE WITNESS: I think that if what
`you're asking me is whether I see the
`same proportion of patients with these
`various and angiogenic disorders as the
`average retina specialist, I think that I
`don't know that I'm at the exact average,
`but I think I'm within, you know, a
`couple standard deviations for each of
`them.
` I'm not sure that my overall
`practice number, absolute number of
`angiogenic eye disorders that I see, how
`it would match up to other practitioners.
`I do see a lot of patients with
`inflammatory eye disorders, which can
`also have angiogenic complications, and
`that might -- that might render my
`absolute numbers somewhat lower than of
`many other practitioners, but I don't
`really know how it would compare to the
`average.
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`14
`
` BY MS. FISHMAN:
` Q. Understood. And I understand that a
`large part of your practice is the treatment of
`uveitis; is that correct?
` A. That is correct.
` Q. Okay. But for the angiogenic eye
`disorder portion of your practice, any reason to
`think that it's, you know, greatly different in mix
`from what other retina specialists are treating?
` MR. SALMEN: Objection to form.
` Asked and answered.
` THE WITNESS: Again, I don't have
` any real data to drive this answer, but
` my gestalt is that I have a practice that
` is very similar to the average medical or
` surgical retina specialist in terms of
` the types of angiogenic eye disorders I
` treat.
` BY MS. FISHMAN:
` Q. Now, Lucentis was approved for wet
`AMD and for the treatment of macular edema
`following retinal vein occlusion by 2011; is that
`
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`15
`
`correct?
` MR. SALMEN: Objection, form,
` foundation.
` THE WITNESS: Can you repeat the
` question again.
` BY MS. FISHMAN:
` Q. I'm just confirming that Lucentis,
`or ranibizumab, had been approved by FDA for the
`treatment of wet AMD and macular edema following
`retinal vein occlusion by 2011.
` MR. SALMEN: Objection, form,
` foundation.
` THE WITNESS: I believe that to be
` true.
` BY MS. FISHMAN:
` Q. And off-label Avastin was used to
`treat wet AMD, retinal vein occlusion, and diabetic
`macular edema by 2011; correct?
` MR. SALMEN: Objection, form,
` foundation.
` THE WITNESS: That is my
` recollection.
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`16
`
` MS. FISHMAN: May I mark Exhibit 1
` and 2 to the deposition of Dr. Albini,
` please.
` THE WITNESS: Is it out of line
` for me to ask the last question to be
` repeated?
` (Record read)
` THE WITNESS: I answered that
` question correctly, and that statement is
` correct.
` (Exhibit 1, Intracitreal
` Bevacizumab (Avastin) Therapy for
` Persistent Diffuse Diabetic
` Macular Edema, was marked for
` identification.)
` (Exhibit 2, Efficacy of
` q1.25 MG Versus 2.5 MG
` Intravitreal Bevacizumab for
` Diabetic Macular Edema, was marked
` for identification.)
`BY MS. FISHMAN:
` Q. I'm handing you what has been
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`17
`
`marked -- I'm going to hand you both Exhibits 1 and
`2.
` A. Thank you.
` Q. This is Exhibit 1 and this is
`Exhibit 2.
` So starting with what I've marked as
`Exhibit 1, it's an article entitled "Intravitreal
`Bevacizumab Avastin Therapy for Persistent Diffuse
`Diabetic Macular Edema."
` Do you have that article in front of you?
` A. I do.
` Q. Okay. And this article reports on a
`prospective case study of 51 patients to evaluate
`the efficacy of bevacizumab, or off-label Avastin,
`for the treatment of diabetic macular edema;
`correct?
` MR. SALMEN: Objection, form,
` foundation.
` THE WITNESS: With the caveat that
` I have not had the opportunity to review
` this entire document and to really
` critically appraise it, it appears what
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`18
`
` you just said reflects what's in the
` abstract of the methods section, so I
` have no reason to doubt that -- that
` summary of the article.
`BY MR. SALMEN:
` Q. And if you turn the page and look at
`the top of the page, this appears to be a
`publication from 2006.
` Do you see that?
` A. I do.
` Q. Okay. So this is just to confirm
`your recollection. Is it fair to say that
`off-label Avastin was used to treat diabetic
`macular edema by 2011?
` MR. SALMEN: Objection to form,
` foundation, mischaracterizes.
` THE WITNESS: I don't think that
` there's anything in this article that
` supports that Avastin was used, although
` I think that is true. The methods within
` this article may be research methods that
` are not widely used outside of the scope
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`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`19
`
` of this article. I don't know. But
` certainly when you're given a research
` article, treatments that are described in
` research articles may not represent
` common use, therapeutic use of agents for
` patients.
` BY MS. FISHMAN:
` Q. Was off-label Avastin -- setting
`aside the particular treatment regimen, was
`off-label Avastin commonly used for the treatment
`of diabetic macular edema and diabetic retinopathy
`by 2011?
` MR. SALMEN: Objection, form,
` vague.
` THE WITNESS: I'm not sure what
` you mean by "commonly." I think that it
` was not unusual in the United States to
` see patients treated with Avastin for
` macular edema in 2011, yes.
` BY MS. FISHMAN:
` Q. And just to clarify, for diabetic
`macular edema in 2011; correct?
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`20
`
` A. For diabetic macular edema.
`Correct.
` Q. You can put aside the second
`exhibit.
` Dr. Albini, retinal neovascularization is a
`feature or complication caused by proliferative
`diabetic retinopathy or ischemic retinal vein
`occlusion; is that correct?
` MR. SALMEN: Object to form.
` THE WITNESS: I think that both
` those disease processes, diabetic
` retinopathy and vein occlusion, can
` result in retinal neovascularization,
` yes.
` BY MS. FISHMAN:
` Q. And when we talk about diabetic
`retinopathy, it can be either proliferative
`diabetic retinopathy or nonproliferative diabetic
`retinopathy; is that true?
` A. That is true.
` Q. And you would treat retinal
`neovascularization by treating the underlying eye
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
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`21
`
`disorder, either retinal vein occlusion or
`proliferative diabetic retinopathy; is that
`correct?
` MR. SALMEN: Objection, form,
` vague.
` THE WITNESS: The most common
` treatment for proliferative diabetic
` retinopathy is a laser treatment that
` ablates the ischemic retina called
` panretinal photocoagulation. It does
` treat the underlying angiogenic disorder
` in the sense that it destroys the
` ischemic retina and reduces the amount of
` VEGF that's in the eye.
` BY MS. FISHMAN:
` Q. When you treat retinal
`neovascularization, do you typically use a VEGF
`inhibitor?
` MR. SALMEN: Objection, form,
` vague, asked and answered.
` THE WITNESS: I'm not sure what
` you mean by "typically." Do you mean in
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`Page 021 of 310
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`22
`
` most cases?
` Q. In most cases -- well, do you treat
`retinal neovascularization in your clinic?
` A. Yes.
` Q. Okay. When you treat retinal
`neovascularization, do you use VEGF inhibitors?
` MR. SALMEN: Objection, form.
` THE WITNESS: I have used them for
` that purpose, but I use laser much more
` commonly.
` BY MS. FISHMAN:
` Q. Do you use VEGF inhibitors in
`conjunction with laser to treat diabetic retinal
`neovascularization?
` A. I have --
` MR. SALMEN: Objection, form.
` Go ahead.
` THE WITNESS: I have done that on
` occasion, but much more commonly I use
` laser alone.
` BY MS. FISHMAN:
` Q. Now, iris neovascularization,
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`Page 022 of 310
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`23
`
`neovascular glaucoma, and optic disc
`neovascularization are all features or
`complications of diabetic retinopathy or ischemic
`retinal vein occlusion; is that correct?
` MR. SALMEN: Objection, form,
` foundation, scope, vague, compound.
` Go ahead.
` THE WITNESS: All of those
` clinical findings, the different types of
` neovascularization that you mentioned,
` neovascularization of the disc,
` neovascularization of the iris, can be
` seen in those disease entities, yes.
` BY MS. FISHMAN:
` Q. Dr. Albini, have you heard the term
`"vitreal neovascularization" before?
` A. I do not believe so.
` Q. What would you understand the term
`"vitreal neovascularization" to refer to?
` A. I really don't know how to interpret
`that term. If I had to guess, it would be growth
`of retinal neovascularization into the vitreous
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`Page 023 of 310
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
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`24
`
`would be the most common form, and I'm sure that
`there could be other forms that are much rarer.
` Q. Okay. And does that happen in
`proliferative -- in other words, the growth of --
`or neovascularization that grows from the retina
`towards the vitreous, does that happen in
`proliferative diabetic retinopathy or ischemic
`retinal vein occlusion?
` MR. SALMEN: Objection, form,
` foundation, incomplete hypothetical.
` THE WITNESS: Totally outside of
` the scope of my opinions, but for this --
` patents, but yes, that does happen.
` BY MS. FISHMAN:
` Q. And is vascular retinopathy a
`general term that would encompass retinal vein
`occlusion and diabetic retinopathy?
` A. I'm not familiar with that term.
` Q. How would you interpret the term
`"vascular retinopathy"?
` MR. SALMEN: Objection, form.
` THE WITNESS: Again, outside of
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
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`25
`
` the scope of anything related to these
` patents. I think that that term would be
` used to describe eye disorders that are
` vascular in nature and involve the
` retina.
` BY MS. FISHMAN:
` Q. And retinal vein occlusion and
`macular edema following retinal vein occlusion and
`diabetic retinopathy would be two such disorders;
`correct?
` A. Again, outside of the scope, but
`yes. Correct.
` Q. I'm handing you, Dr. Albini, what's
`been marked as Mylan Exhibit 1114, which is a copy
`of your expert declaration in the '0881 proceeding
`involving the '338 patent.
` I'd like to direct your attention to
`Paragraph 18 in your declaration, Exhibit 1114.
`And you're discussing here the specification of the
`'338 patent. If you need to look above for the
`context, feel free to do that.
` Paragraph 18, you write: "The first
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`26
`
`sentence in this paragraph reads 'Methods for
`treating eye disorders using VEGF antagonists are
`mentioned in, for example,'" and you list four
`patents and a patent publication, a published
`patent application.
` Do you see that?
` MR. SALMEN: Objection, form,
` mischaracterizes.
` THE WITNESS: I think this is a
` direct quote from the '338 specification.
` So when you say "I list," I do only by
` virtue of directly citing what's in the
` patent specification.
` BY MS. FISHMAN:
` Q. Fair enough.
` And then the next sentence goes on, and it
`says -- you say, "In my opinion, a POSA would read
`this statement as POs, or patent owners,
`description of the state of the art that the
`claimed method seeks to improve."
` A. I'm so sorry. I lost you,
`unfortunately. So we went from this quote of the
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`27
`
`specification? And the next part?
` Q. The next sentence, which carries
`over --
` Are we looking at the right document?
` A. This is 17?
` Q. Looking at Paragraph 18. Do you see
`Paragraph 18?
` A. I do. It starts "The first sentence
`in the paragraph reads"?
` Q. Yes.
` A. Oh, okay.
` Q. And then if you go over to the
`second sentence, I was reading your second
`sentence.
` So starting again. You write, "In my
`opinion, a POSA would read this statement as patent
`owner's description of the state of the art that
`the claimed method seeks to improve."
` Do you see that?
` A. Yes.
` Q. And you go on and you note that
`you've reviewed the four patents and the one
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
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`28
`
`published patent application for disclosures of
`methods for treating eye disorders using VEGF
`antagonists.
` Do you recall that?
` A. Yes.
` Q. So I'd like to direct your attention
`to Paragraph 23 of your declaration where you're
`discussing in particular what you call the '058
`publication, which is Exhibit 35.
` Take a moment just to review that
`paragraph.
` A. (Witness complies with request.)
` Q. Just let me know when you're done.
` A. Yes, I've reviewed it.
` Q. I'm going to hand you now what's
`been marked as Mylan Exhibit 1135 in this
`proceeding. And just to confirm, this is the '058
`publication that you reference in Paragraph 23;
`correct?
` A. That is correct.
` Q. Okay. And you've reviewed
`Exhibit 1135; correct?
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`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
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`29
`
` A. Yeah, this is Exhibit 1135.
` Yes, I have.
` Q. Okay. And let's take a look at it.
`So Exhibit 1135 is a Genentech published patent
`application; correct?
` A. Correct.
` Q. And if you look under the related
`U.S. application data, you see "provisional
`application filed on October 21, 2004."
` Do you see that?
` A. I do.
` Q. Do you understand that this
`published patent application claims priority back
`to October 2004?
` MR. SALMEN: Objection, form,
` legal conclusion.
` THE WITNESS: Not being a patent
` attorney, I think that that seems
` correct.
` BY MS. FISHMAN:
` Q. Do you see that Naveed Shams is the
`named inventor on this published patent
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
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`30
`
`application?
` A. I do see that.
` Q. Okay. If you turn the page to
`page 2 and 3, you'll see there's a figure 1 and a
`figure 2 in the '058 publication?
` A. I see that.
` Q. If I call the '058 publication
`"Shams," will you understand what I'm referring to,
`or is that confusing for you?
` A. If you call this entire publication
`"Shams"?
` Q. Yes.
` A. That does seem confusing.
` Q. That's fine. I'll refer to it as
`the '058 publication, then.
` And so if we take a look at figure 1 and
`figure 2 of the '058 publication, figure 1 shows a
`trial design; correct?
` A. Correct.
` Q. And figure 2 shows a treatment
`schema; correct?
` A. Correct.
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Conducted on June 22, 2022
`
`31
`
` Q. And the trial design involves three
`different dosing arms; is that correct?
` MR. SALMEN: Objection, form.
` Document speaks for itself.
` THE WITNESS: I think that would
` be a very reasonable way to interpret the
` scheme. It's just a cartoon, so I don't
` want to overinterpret from it, but that's
` what it seems to be suggesting, yes.
` BY MS. FISHMAN:
` Q. Okay. And if we take a look at
`figure 2, the treatment schema, figure 2 shows
`three groups or three arms; correct?
` A. Correct.
` Q. One arm is receiving 0.3 milligrams
`ranibizumab, one arm is receiving 0.5 milligrams
`ranibizumab, and then the last arm, or the control
`arm, is receiving sham injection; is that correct?
` MR. SALMEN: Objection, form.
` THE WITNESS: Again, at the
` possible expense of overinterpreting this
` cartoon, I believe that that's true.
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`Exhibit 2287
`Page 031 of 310
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`
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`CONFIDENTIAL
`Transcript of Thomas Albini, M.D.
`Co
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