# Profoundd archive — Epstein Files
# Bates number: EFTA00810552
# Title:        EFTA00810552
# Dataset:      9
# Pages:        24
# Images:       24 detected
# Tags:         epstein, doj, dataset-9, image-described
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#----------------------------------------------------------------------

=== SUMMARY ===
EFTA00810552 Forward looking statements veru INICOMMoNC063ACOMOnSkeeeed-1501Ing Skilanenlswankt the MeONN2 Of the Prty0105,3~10(4 U110060nRelOrM ACIOl 1995. 11.93 SIONMUMIS Ore Subjekt 10 bidral on unknown aks. uncortalmes and assumptin adb:ny such risks or uncerlonles malorkiao or i any of the assurnplions prove incorrocl. os aclual ros" coud delar molbed Man Mose aquessed ar ~ed by sua staemeres. factors bal may causa aclud results to older material:y korn Mose contemreated by such lonvad bobr


=== EXTRACTED TEXT ===
EFTA00810552
Forward looking statements 
 veru INICOMMoNC063ACOMOnSkeeeed-1501Ing Skilanenlswankt the MeONN2 Of the Prty0105,3~10(4 U110060nRelOrM ACIOl 1995. 11.93 SIONMUMIS Ore Subjekt 10 bidral on 
unknown aks. uncortalmes and assumptin adb:ny such risks or uncerlonles malorkiao or i any of the assurnplions prove incorrocl. os aclual ros" coud delar 
molbed Man Mose aquessed ar ~ed by sua staemeres. factors bal may causa aclud results to older material:y korn Mose contemreated by such lonvad bobrq 
s101eMenn nekt». bul ote n3Y briter:110: raf reelked SO tre Cltrekenu3n101 Verv MC. % (Me -COrrgeny,OrOrirel pollab. bidvang ~0116M. reoul0ary OpprOwlIS end 
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Monene On OCOM)10ble terms ...hen n.)~0 ro lund deveropmenl ond Comp0ny OCKYOlier6.PrvduCt elemonClorKlenOrtelOCCesalonCe. COmpemon in Me COnp0nys 
maten and Me rist ol news Sting ~petiten~ arealer rosources and capablees and reve company* procbc1 rntroduchons: the ilsk In sale: bong oflocted by 
ropulakey dembpments. Inaludng a readuncatnn od Me producle price erosen. bom hom ~pang procbch and inaecced government 'anane prosauros: mcnufaclurhg 
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polental kcal manufactumg relattves. whchcouldrectce mo sto od ble emmi lo Ile [brobry: te Company% ~ce onlIs internalkeed partners and on Me lovd ol 
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Co_ Alet Capllal Malers, 459 tak Avenue. da Hoa. Ho* York, NY 101122, by telephone al 2124129.7122. 
EFTA00810553
Pipeline of proprietary product candidates and specialty pharmaceuticals vent 
PRODUCT INDICATION TARGET PREcuNICAE PHASE, PHASE 2 PHASE 3 PHASE.. 
PROSTATE CANCER NOVEL MEDICINES 
Zuclomiphene 
Capsules 
VERU• I 1 (13 nclole) 
Capsules Hot flashes caused 
by prostate cancer 
hormone treatment 
Metastatic prostate 
cancer Non steroidal 
estrogen agonist 
Oral, targeted 
a • $ htbulin 
inhibitor 
EI:112== UROLOGY SPECIALTY PHARMACEUTICALS 
Tomsulosin DRS 
granules 8 XR capsules 
(tamsulosin HCI) 
Todolafli-finasteride 
combo tablets (5mg 
todalafli /5mg 
linasteilde) 
Soldenacln DRG 
(solltenacln granules 
oral suspension) BPH (no food effect) 
IIPH a erectile 
dysfunction 
Overactive 
bladder Super selective a- 
receptor blacker 
with no food effect 
PDS • 
So reductose 
inhibitors 
Selective M3 
muscarinic 
antagonist CS2=322aa 
3 
EFTA00810554
Experienced in clinical practice, drug development and commercialization vett 
Mitchell Steiner, MD 
CHAIRMAN, PRESIDENT & 
CEO 
CEO & President Aspen Pork 
Pharmaceuticals. President of 
Urology at OPKO Health. Inc.: 
CEO & Founder Cir. Inc.: 
urologist Michele Greco, CPA 
CHIEF FINANCIAL & 
ADMINISTRATIVE OFFICER 
CFO/EVP the Female Health 
Company. 28 years with Frost & 
Young, 15 yeas as an Audit 
Partner 
Kevin Gilbert, JD, CPA 
EVP CORPORATE 
DEVELOPMENT 
Corporate Development & Legal 
Third Stream Bioscience. Attorney 
at McDermott. Will & Emery, 
Motorola. dosed more that 100 
transactions in 25 countries Gary Barnette, PhD 
CHIEF SCIENTIFIC OFFICER 
Sr. VP Scientific and Reg Affairs 
Camorgo Phcrm. Services. VP 
Cfnical & Reg and Founder GTx, 
Inc., Director Reg Affairs Solvay 
Phormo. Clinical Pharmacology! 
Biopharmoceutics Reviewer FDA. 
PhD Basic Pharmaceutical 
Sciences west Virgin° University 
Philip Greenberg, JD 
EVP LEGAL 
General Counsel Latin Arnenca 
Teva Pharmaceuticals with prior 
senior legal positions in 
international and North America 
divisions; Deputy General 
Counsel for VAX Corporation Harry Fisch, MD 
CHIEF CORPORATE OFFICER 
Chairman Aspen Park 
Pharmaceuticals and Millennium 
Sciences. Inc.: urologist 
Phil Kuhn, MBA 
EVP STRATEGY AND 
COMMERCIALIZATION 
Global Strategy and Commercial 
expertise in medical devces. 
aognostics. and biologics: 
leadership roles at ISTO Biologics, 
Orthofix, Smith & Nephew, Boston 
Scientific, Johnson & Johnson. and 
Abbott 
UPDATED 
EFTA00810555
u 1 
Prostate Cancer -
Novel Medicines 
EFTA00810556
Zuclomiphene: potential to be the first FDA approved drug for hot flashes 
caused by prostate cancer hormone therapy 
Hot flashes are one of the most 
common and debilitating side effect 
of androgen deprivation therapy 
(ADT) for advanced prostate cancerl• 2
• Occurs in up to 80% of men treated 
with ADT (leuprolide or degarelix) with 
30-40% having moderate to severe hot 
flashes'-3
• Symptoms do not subside over time 
• 44% of men of S yews and 40% of men of 8 
yeas slit suffer from hot floshes2
• Concern over hot flashes make 
patients less likely to begin ADT and 
can lead to early discontinuation 2A veru 
Zuclomiphene (aka cis-clomiphene) 
is an oral estrogenic agent" 
• Isolated cis-clomiphene from CLOMID 
(30% cis- and 70% trans-clomiphene; 
approved in 1967 for female infertility( 
• Efficacy established for estrogens: off-
label steroidal estrogens are effective 
but have safety concerns" 
• FDA database and scientific literature 
show cis-clomiphene component of 
CLOMID is well tolerated with over 
88,000 men/years using CLOMID off 
label for infertility or hypogonadism 
Gomelb LG el al EUU intsi:25.292037likarinp P el all UV 15211701173 199A %•Gavale2 BDatoll Urol 194690495 20151,03101SerallSuppore 
Dace. 43,5 320 2004 I guano' It1 el cd Endocnnolow 1397771220 Fontenot GC el dim ht I I 7N4,50. 20161..fones lm tt cl Auon JAr4obae 
14:192.19720 ,21' Spell AC el of 1 Supped OrCei 426.3.2732C431. ,COmeree Plume Clekof Report 3/ 17 axl FDA SdeiroDoCurnenl BRUDAC AcNiscee 
rneerg 17/16 
EFTA00810557
Zuclomiphene clinical development plan: Phase 2 trial design 
IND accepted 7/18 
Phase 2 placebo controlled dose finding study 
First subject expected in 9/18 & final data 
expected 1H 2019 
Plan to enroll 120 men who have moderate & 
severe hot flashes on ADT in 10 US clinical sites 
• Primary efficacy endpoint- mean change in 
frequency of moderate 8, severe hot flashes from 
baseline to week 4 and maintained until week 12 
• Power 8O%; 40% improvement compared to 
placebo 
• Placebo effect from literature is 22%' 
• Secondary endpoints- bone turnover markers averu 
Lopinzi el o12009. Annals of Oncology p1 .8 ICOLI0.I093/annenc/mcfn644 :Table 21 0 mg  
Primary endpoint Primary endpoint 
4 weeks 12 weeks 
7 
EFTA00810558
Zuclomiphene: greater than $600 million/year expected market 
Market potential 
• Indication: treatment of castration -induced 
hot flashes in men with advanced prostate 
cancer on ADT 
• Estimated 600,000 men on hormonal 
therapies (androgen deprivation therapy as 
well as novel androgen blocking agents) in 
the U.S.' 
• Over a $600 million/year expected market? 
Intellectual property 
• Patent (U.S. No. 9.913.815) issued March 2018, 
expiry 2035- method of use 
• Polymorph identified- composition of matter 
patents filed veru 
Scher et cr. PtoS ONE 2015 101-12 (DOI:10.1371(rotmeloone013Pee0 I r Rd to:oleo ocoinike boon on XX of 400000 men io US on AD1 have moderole to more ivt norhesilthe once was Sa3C0 hoot of freemen! 
8 
EFTA00810559
VERU-111 may address key limitations of current prostate cancer treatments 
The only effective agents against advanced and metastatic 
prostate cancer are hormonal and antitubulin cytotoxic 
drugs 
Androgen blocking agents ZYTIGA (abiraterone) and 
XIANG' (enzolutomide) have significant cross resistance 
Men who progress on these agents are being healed with 
antilubulin chemotherapies 
Current antitubulins have challenges' 
• Only evadable as intravenous administration 
• Drug resistance is common- multidrug resistance 
proteins. tubulin mutations and overexpression 
• Safety concerns- hypersensitivity reactions, 
neutropenia, and neufoloxicily (peripheral 
neuropathy & muscle weakness) 
'Domoid t ar ol art Treat Opica:Oncci 16:9 2015 
9 
EFTA00810560
VERU-111: novel, oral, next generation, tubulin inhibitor 
targeting a and p subunits of microtubuies 
Precllnical Product profilel-3
• low nanomolar inhibition of tubulin polymerization 
• High oral bioovailability 
• High brain penetration 
• Not a substrate for MDRs MRPs. and BCRP) 
• Not a substrate for CYP3A4 
• Efficacy against prostate and other cancers in vitro 
and in vivo 
• Demonstrated activity against taxane. vinca alkaloid, 
doxorubicin, enzalutarnide, and abiraterone resistant 
cancers 
• Favorable safety profile (less neurotoxicity than 
docetaxel and unlike taxanes and vinca alkaloids -no 
neutropenia or myelosuppression) 4MICROTUBULE veru 
Chen J el al. J Med Chem 55:7285-7289 2012 I1 Li CM el CI. MOM, Res 29:3053-3043 2012 I Le Y el all Abed Chem 57:73553364 2014 I'28 day 
ral and dog loxily :ladies an file al veta. hC. 
EFTA00810561
VERU-111 builds on a proven mechanism - inhibiting microtubule assembly yew 
Microtubule assembly 
VERU-111 
(Crossilnks a and (1 subunits 
and Inhibits polymerization) control 
"spindle shape" Microtubules (red) disrupted from 
spindle to globular shape 
VERU-111 
"globular shape" 
Triple negative human breast cancer xenograft 
(MDA-M8-231)i 
',unmet, ASCO abstrach 2018 
ct profile 
11 
EFTA00810562
VERU-111 inhibits growth of taxane-resistant prostate cancer' 
PC-3 
2503 
'coo • 
• .,e 20:0 
600 E e 
E 600 • € 1503 
°. • • Z : TKO 
2P 100 
i O - e - -1/4., f 
2 303 100 
o. ..0 
• 2 4 • • II 12 14 IS 16 16 PC-3/TxR 
. Wittes 
cee...rcaroma a.. 
0... .•• 12 14 16 IS 20 
I = VERU-I 11: PO- oral dosing: intravenous dosing: mpk- mg per kg 
Treatment flitiated when tumors reached 150-300 mms veru 
• PC-3 and taxane-resistant PC-3 (PC-
3/TxR) human prostate cancer 
xenografts were grown in mice 
• Figure a- demonstrates that PC-3 
calk ore inhibited by a 'axone 
Idocetaxel) 
• Figure b- indicates PC-3/NR are 
indeed resistant too taxone 
Idocetaxel) 
• VERU-111 inhibited growth of taxane 
resistant human prostate cancer 
xenografts (3.3.6.7 mg/kg) 
' U Caa et d. otxnn R0689.70534363 2012 
12 
EFTA00810563
VERU-111 inhibits prostate cancer tumors resistant to novel androgen blocking 
(AB) agents with no effect on body weight (surrogate for toxicity) veru 
22Rv1- human prostate cancer model' 
• Contains androgen receptor • Resistant to novel AB agents: 
variants including AR-V7 enzalutamide and obiroterone 
Efficacy (median tumor volume) 
•••••••••••••• WM. MA 
 to
.P'1101
PASCO obf000IS 2018 SPNcelo0 ...WO .II )0•41141001 
.Y•••0111111. I MAW* SOKKOt110•04*I Safety (% starting body weight rats) 
Receb) 12226 12211 
VERµ111 Say)* 12753 1251$ 00370 
P0) 
VERIA11120100 12412 124.33 02031 
PO) 
Dxsisca1 lOnvoltg II106 moo 0/133 
011 
DOIMAI teleate MUM ••••••••0010! OW ID ',WOW tell1011101•••••11P4.0415) 
13 
EFTA00810564
VERU-111 clinical development plan: Target castration and novel androgen 
blocking agent resistant metastatic prostate cancer veru 
First in class, next generation, novel oral agent that targets a and 13 subunits of tubulin 
nog ADT 
P
Hormone sensitive 
metastatic prostate 
cancer S 
rt 
'401ADT • 
novel A8 agent: 
enzatutornde or 
abiraterone re
71:VERU•111 
IF 4 
Castration resistant Castration and novel androgen 
metastatic prostate blocking agent resistant 
cancer metastatic prostate cancer nor. antiogon 604641.11441 
reap/ 
ispptht aear000n bMWq 
OWN. ere0/04Ticin 
0440144040.614 4 pOlularlikle 
14 
EFTA00810565
VERU-111 clinical development: we expect open label clinical data Q1 2019 veru 
Successful pre-IND meeting with FDA 9/18 
IND and Phase 1/2 expected calendar Q4 2018- Johns Hopkins Cancer 
Center (lead center) 
Men with metastatic castration resistant prostate cancer who have progressed on 
novel androaen blocking agent (either enzalutamide or abiraterone) and ± 1 taxane 
r‘ 
Phase 1 
3+3 design Phase 2 open label study 
Primary endpoint- PSA reduction 
N=15 N=26 
castration and novel androgen 
blocking agent resistant 
metastatic prostate cancer 
Fix superscript. 
EFTA00810566
VERU-111 has potential to treat multiple indications in prostate cancer 
t • Indication 2- novel AS agent and taxane chemotherapy resistant mCRPC 
AD1 • 
enzalutarrkle or 
obioierone 
ttataCeteeel
nitcabcartwel  VERU• Ill 
--.—± veru 
antioarnarerbedah 
reeler 
neme MI 59~ 
enZaklarrele CO ralenCee. 
Ondageteleeide 
CO:nutan ten:tent rennet AD agent DOCetaXel (lanCetel latale rentlent 
trek.. ute ettneate ractent metcaolic tenGlant rneneelata mole:tale latettatn 
con [...• pratale Cancer POState <0.100‹ COPSE,
Indication 3- Is fine mCRPC resistant to novel Al agents Indication 4- I* line hormone sensitive metastatic prostate cancer 
AD? • 
cpaeMridea 
Sniaulan'ide 
tionmelOstate costa:Mon 
Mealtime (MO) with Noll RSA 
ckobang time on ADI ee, MelplOsiS PM/ 
vERU-I I I 
enCRPC fe./%1Off IO 
00,9! AS 00enh ALIT plus 
VERU-I It 0~1 syvhol win IV 
ciccelaxel pus A011:24 
IN 9 t a ADI 
dens,
Hanle,. %MOW* eneta•aliC 
pasta* cancer 
Seeenei NUM 2015 (0C1 10 10050*.loolS0)747) 
16 
EFTA00810567
VERU-111 has applications in multiple areas of oncology; strong IP 
4 abstracts at ASCO 2018 
VERU-I II HAD EFFICACY AGAINST THE FOLLOWING 
HUMAN CANCER XENOGRAFT MODELS 
• 22Rv1- human metastatic prostate 
cancer line resistant to enzalutamide 
and abiraterone 
• Triple negative breast cancer 
• Ovarian cancer 
• Pancreatic cancer veru 
Over 29 peer-reviewed publications 
7 issued composition of matter patents 
Including U.S. 9029408, EU 2959900 and 
Japan 5507552 
• U.S. potent expiry 2029 with possible 
extension to 2034 and 63 foreign 
granted or pending patents 
• Polymorphs identified to extend time for 
composition of matter coverage 
EFTA00810568
VERU-111 market opportunity 
Current market for advanced 
prostate cancer drugs 
• $5 billion market for secondary novel androgen 
blocking agents for prostate cancer' 
• $4.8 billion market for anlitubulins such as vino 
alkaloids & taxans Idocetaxel $1 baron ond 
caborilaxel $500 ~on in prostate cancer) 
• VERU-I I I potential global market greater than 
$5 billion for prostate and other cancer types veru 
VERU-111, like current antitubulins, 
may have efficacy against broad 
cancer types 
• VINCA ALKALOIDS: VELBAN (VINBLASTINE): 
ONCOVIN (VINCRIST1NE): NAVELBINE 
(VINORELBINE) Prirricrily used in combination 
chemotherapy (ABVD. Stonford-V, CHOP. MOPP) For 
hematologic malignancies (leukemia. tympharna, 
and myeloma). and neuroblastoma. thyroid cancer, 
sarcoma ond non smal cell lung cancer 
• TAXANES: TAXOL (PACLITAXEL); TAXOTERE 
(DOCETAXEL): JEVTANA (CABA/ITAXEL): 
ABRAXANE (PROTEIN BOUND PACLITAXEL) 
~only used for said tumors such as breast, ovarian. 
endometriol. cervical. lung. head and neck, 
esophageal. bladder. gastric. and prostate 
~me krellgen:e I nips 'Haw the rAo:toTecercer matte:vet cner.ae over nod decode' ar Kevn Gregon 
EFTA00810569
19 
EFTA00810570
Urology specialty pharmaceuticals: 
NDAs for 3 drug products to be submitted 2019 
Product veru 
Indication Formulation and 
advantages Market Status 
Tamsulosin XR BPH 0.4 mg Stow release 2017 US market- Final bioequivolence 
capsules and granules with no food 28,341A04 scripts study will be 
granules Branded- Flomax effect completed 2018 
Long term core-
Sprinkles for dysphagia 3.126.003 scripts NDA 2019 
Compliance & safely 
Tadalafil-finasteride BPH- enlarged Combination tablet Bioequivolence 
combination tablet prostate containing 5 mg tadolafil study will be 
Erectile and 5 mg finasteede Estimated US $150 completed 2018 
dysfunction 
Convenience and NDA 2019 
Brand- Compliance 
Cioks/Proscar 
Solifenacin DRG Overactive Sprinkles for dysphagia Long term core Bic-equivalence 
granules bladder study 2018/2019 
Estimated US $150 
Brand- Vesicore NDA 2019/2020 
EFTA00810571
Commercial 
Product 
21 
EFTA00810572
) and 
nd FC2 Female Condoms business profitable from FY 2006- 2017' 
FC2 Female Condom only FDA approved female use 
product that protects against pregnancy & STDs 
• Sold in U.S. and 149 countries 
• Manufacturing plant with 100 noon units annual capacity 
• Public sector represents approx. 90% of revenue (customers 
include UNFPA, USAID. Brazil, and South Africa( 
• FC2 business profitable from FY 2006-FY 2017' 
Global public sector revenues 
• Base revenue $14 million in FY 
2017 
• Awarded South African tender 
8/18 - should add $10.4 miEion in 
revenue/year for approx. $31 
million over 3 yeas veru 
Building US prescription business 
for high margin revenue 
• Working with Cardinal Distribution. 
Amerisource Bergen, McKesson. 
and Anda to support broad FC2 
pharmacy avaiability 
• Prescription business is growing 
'Forli:colvCa12wolnougt,lmcci yea 7316. prolloOlty is =eel on Vents rot income ottne,itoble to common Ilocknotder. Foe It col yaw 2017.11101n' 
rscol wof .11Chintle0e$ me l'nonCol,09" Of Aspen Nut PhoirroCeol;Oci,. peonl0taily 6 boyecj on opero+ro inccrne 'tom ON COmmerC101 Wren!. 
22 
EFTA00810573
Financial highlights (in millions) 
Capitalization approximately 54.7 million' common shares outstanding as of June 30, 2018 
Balance sheet as of June 30, 2018 
• Cosh and receivables $9.2 
• UK NOL carryforward $62.2 
• US NOL carryforwarcl $10.5 
$10 million received In March 2018 under SWK Holdings synthetic royalty financing on FC2 
Female Condom" product sales 
Results of operations for the nine months ended June 30. 2018 
• Net revenues $10.7 
• Gross ptotil $ 5.6 
• Operating loss $17.1 
Results of operations for the year ended September 30, 2017 
• Net revenues $13.7 
• Gross atoll, $7.0 
• Operating loss $8.5 
Adittos.4 440onts reelscOef elett4 setts estl Wren,. awe outtesArtt are are, or wail rct +'airy be seedwclly ensue et 'Inn 54 test Pen oyerron 
oNa.o. aSoto I Soo 'ettet Ito, SEC clocuteos14 S:e acIatcPal rtcrrnati:n 10
23 
EFTA00810574
Veru projected development milestones veru 
PRODUCT INDICATION 2018 2019 2020 
PROSTATE CANCER NOVEL MEDICINES 
Zuclomlphene 
capsules 
VERU-111 (bisindole) 
capsules 
UROLOGY SPECIALTY 
Tamsulosin XR 
granules 8. capsules 
Tadalafil-lina steride 
combo tablets 
Solifenacin DRG 
granules Hot flashes caused by 
prostate cancer 
hormone therapy 
Metastatic prostate 
cancer 
PHARMACEUTICALS 
BPH without food 
effect 
BPH and erectile 
dysfunction 
Overactive bladder in 
patients with dysphagia IND P2 1 P. 
PlID/P2 
NDA..ND 
P3 
PoR approval 'clef), Rudy 
US launch 
NDA US launch 
US launch 
24 
EFTA00810575



=== IMAGE DESCRIPTIONS ===
[Image 1] The image appears to be a digital slide from a presentation, possibly related to medical or health information. The slide features a photograph of a man on the right side, who is smiling and appears to be in good health. He is wearing a dark-colored top and is outdoors, as indicated by the natural lighting and greenery in the background.

On the left side of the slide, there is text that reads "Pr

[Image 2] The image appears to be a digital slide from a presentation, possibly related to a company or organization. The slide has a green and white color scheme with a logo in the top left corner that reads "veru." Below the logo, there is a photograph of an older man riding a bicycle on a road with a mountainous landscape in the background. The text on the slide includes the words "URGENT SPECIALITY PHAR

[Image 3] The image shows a digital document with a purple and white color scheme. The document appears to be a presentation slide or a report cover. At the top, there is a logo with the text "VERU" in white letters on a purple background. Below the logo, there is a title that reads "Precision Medicine for Prostate Cancer" in white text on a purple background. The date "OCTOBER 2021" is visible at the botto

[Image 4] The image appears to be a photograph of a document with text. The document is titled "FORWARD LOOKING STATEMENTS" and includes a logo at the top right corner that reads "VERITAS." The text is too small to read in detail, but it seems to be a standard corporate or financial document, possibly related to financial statements or future projections. The document is printed on a white paper and is disp

[Image 5] The image appears to be a slide from a presentation, specifically focusing on a scientific or technological topic. The slide is titled "VIBGYOR" and includes a subtitle "MICRON BIOMEDICALS." There is a diagram illustrating a structure that resembles a microscopic view of a cell, with various components labeled, such as "Nucleus," "Mitochondria," and "Lysosomes."

Below the diagram, there is a phot

[Image 6] The image appears to be a slide from a presentation, possibly related to a scientific or medical topic. The slide is titled "Vaccine Development" and includes a subtitle "Vaccine Product Development." There are bullet points with text that are too small to read clearly, but they seem to outline the process or steps involved in vaccine development. On the right side of the slide, there is a graphic