CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`212480Orig1s000
`
`
`OTHER REVIEW(S)
`
`

`

`FOOD AND DRUG ADMINISTRATION
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`****Pre-decisional Agency Information****
`
`
`
`
`Memorandum
`
`Date:
`8/15/19
`
`
`To:
`
`
`
`
`Philip Villasurda
`Regulatory Project Manager
`Division of Antiviral Products (DAVP)
`
`Nima Ossareh, Regulatory Review Officer
`Office of Prescription Drug Promotion (OPDP)
`
`Sam Skariah, Team Leader, OPDP
`
`
`From:
`
`
`
`CC:
`
`Subject:
`
`OPDP Labeling Comments for HARVONI® (ledipasvir and sofosbuvir)
`tablets, for oral use, HARVONI® (ledipasvir and sofosbuvir) oral granules,
`SOVALDI® (sofosbuvir) tablets, for oral use, and SOVALDI® (sofosbuvir)
`oral granules
`
`
`NDA/BLA: 205834/Supplement 29 and 212477 204671 Supplement 14
`
`
`
`In response to DAVP consult request dated March 19, 2019, OPDP has reviewed the
`proposed product labeling (PI) and patient package insert (PPI) for HARVONI® (ledipasvir and
`sofosbuvir) tablets, for oral use, HARVONI® (ledipasvir and sofosbuvir) oral granules,
`SOVALDI® (sofosbuvir) tablets, for oral use, and SOVALDI® (sofosbuvir) oral granules.
`These supplements revise the label to provide information on the efficacy in patients 3 years of
`age and older.
`
`PI: OPDP’s comments on the proposed labeling are based on the draft PI and PPI received by
`electronic mail from Division of Antiviral Products (DAVP) on August 12, 2019 and are
`provided below.
`
`PPI: A combined OPDP and Division of Medical Policy Programs (DMPP) review of the PPI
`will be completed under a separate cover.
`
`Thank you for your consult. If you have any questions, please contact Nima Ossareh at (240)
`402-2769 or nima.ossareh@fda.hhs.gov.
`
`
`
`
`
`
`
`
`
`Reference ID: 4478120
`
`1
`
`88 Page(s) of Draft Labeling have been Withheld in Full as b4
`(CCI/TS) immediately following this page
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`NIMA OSSAREH
`08/15/2019 04:01:08 PM
`
`Reference ID: 4478120
`
`

`

`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Medical Policy
`
`PATIENT LABELING REVIEW
`
`August 13, 2019
`
`Debra Birnkrant, MD
`Director
`Division of Antiviral Products (DAVP)
`
`LaShawn Griffiths, MSHS-PH, BSN, RN
`Associate Director for Patient Labeling
`Division of Medical Policy Programs (DMPP)
`
`Nima Ossareh PharmD, RAC
`Regulatory Review Officer
`Office of Prescription Drug Promotion (OPDP)
`
`Morgan Walker, PharmD, MBA, CPH
`Senior Patient Labeling Reviewer
`Division of Medical Policy Programs (DMPP)
`
`Review of Patient Labeling: Patient Package Insert (PPI)
`
`SOVALDI (sofosbuvir)
`
`oral granules
`
`NDA 212480 and NDA 204671/S-014
`
`Gilead Sciences, Inc.
`
`
`Date:
`
`To:
`
`
`Through:
`
`From:
`
`Subject:
`
`Drug Name (established
`name):
`Dosage Form and
`Route:
`Application
`Type/Number/
`Supplement Number:
`Applicant:
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4476490
`
`

`

`INTRODUCTION
`On February 28, 2019, Gilead Sciences, Inc. submitted for the Agency’s review an
`original New Drug Application (NDA) 212477 for SOVALDI (sofosbuvir) oral
`granules. This original NDA references NDA 204671/S-014 SOVALDI (sofosbuvir)
`tablets. This application is intended to support the approval to market SOVALDI
`(sofosbuvir) oral granules for use in the treatment of hepatitis C virus (HCV)
`infection in pediatric patients.
`This collaborative review is written by the Division of Medical Policy Programs
`(DMPP) and the Office of Prescription Drug Promotion (OPDP) in response to a
`request by the Division of Antiviral Products (DAVP) on March 28, 2019 for DMPP
`and OPDP to review the Applicant’s proposed Patient Package Insert (PPI) for
`SOVALDI (sofosbuvir) oral granules.
`
`
` MATERIAL REVIEWED
`• Draft SOVALDI (sofosbuvir) oral granules PPI received on February 28, 2019,
`revised by the Review Division throughout the review cycle, and received by
`DMPP and OPDP on August 2, 2019.
`• Draft SOVALDI (sofosbuvir) oral granules Prescribing Information (PI) received
`on February 28, 2019, revised by the Review Division throughout the review
`cycle, and received by DMPP and OPDP on August 2, 2019.
`
`1
`
` 2
`
`
`3 REVIEW METHODS
`To enhance patient comprehension, materials should be written at a 6th to 8th grade
`reading level, and have a reading ease score of at least 60%. A reading ease score of
`60% corresponds to an 8th grade reading level.
`Additionally, in 2008 the American Society of Consultant Pharmacists Foundation
`(ASCP) in collaboration with the American Foundation for the Blind (AFB)
`published Guidelines for Prescription Labeling and Consumer Medication
`Information for People with Vision Loss. The ASCP and AFB recommended using
`fonts such as Verdana, Arial or APHont to make medical information more
`accessible for patients with vision loss.
`In our collaborative review of the PPI we:
`simplified wording and clarified concepts where possible
`•
`•
`ensured that the PPI is consistent with the Prescribing Information (PI)
`•
`removed unnecessary or redundant information
`•
`ensured that the PPI is free of promotional language or suggested revisions to
`ensure that it is free of promotional language
`ensured that the PPI meets the criteria as specified in FDA’s Guidance for
`Useful Written Consumer Medication Information (published July 2006)
`
`•
`
`
`
`
`
`
`
`Reference ID: 4476490
`
`

`

` 4
`
` 5
`
` CONCLUSIONS
`The PPI is acceptable with our recommended changes.
`
` RECOMMENDATIONS
`• Please send these comments to the Applicant and copy DMPP and OPDP on the
`correspondence.
`• Our collaborative review of the PPI is appended to this memorandum. Consult
`DMPP and OPDP regarding any additional revisions made to the PI to determine
`if corresponding revisions need to be made to the PPI.
` Please let us know if you have any questions.
`
`
`
`
`
`Reference ID: 4476490
`
`6 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/
`TS) immediately following this page
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`MORGAN A WALKER
`08/13/2019 11:44:34 AM
`
`NIMA OSSAREH
`08/13/2019 12:44:11 PM
`
`LASHAWN M GRIFFITHS
`08/13/2019 01:17:19 PM
`
`Reference ID: 4476490
`
`

`

`LABEL, LABELING, AND PACKAGING REVIEW
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the public***
`
`Date of This Review:
`June 21, 2019
`Requesting Office or Division:
`Division of Antiviral Products (DAVP)
`Application Type and Number: NDA 204671/S-14 and NDA 212480
`Product Name and Strength:
`Sovaldi (sofosbuvir)
`Tablets: 400 mg; 200 mg
`Oral Pellets: 150 mg; 200 mg
`Single Ingredient Product
`Prescription (Rx)
`Gilead Sciences, Inc (Gilead)
`February 28, 2019 and March 14, 2019
`2019-483 and 2019-468
`Valerie S. Wilson, PharmD
`Sevan Kolejian, PharmD, MBA
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`FDA Received Date:
`OSE RCM #:
`DMEPA Safety Evaluator:
`DMEPA Team Leader:
`
`1
`
`Reference ID: 4452620
`
`

`

`REASON FOR REVIEW
`1
`Gilead submitted an efficacy supplement for Sovaldi (sofosbuvir) tablets (NDA 204671/S-014) to
`support expansion of the patient population and the addition of a new strength of Sovaldi
`tablets (200 mg). Additionally, Gilead submitted New Drug Application (NDA) 212480 to
`support the addition of Sovaldi 150 mg and 200 mg oral pellets to the Sovaldi product line.
`Subsequently, the Division of Antiviral Products requested that we review the proposed labels
`and labeling for areas that may lead to medication errors.
`These applications are intended to share a single U.S. Prescribing Information. Thus, this review
`includes our combined assessment of both NDA 204671/S-014 and NDA 212480.
`
`2 MATERIALS REVIEWED
`We considered the materials listed in Table 1 for this review. The Appendices provide the
`methods and results for each material reviewed.
`Table 1. Materials Considered for this Label and Labeling Review
`Appendix Section
`Material Reviewed
`(for Methods and Results)
`A
`B
`C (N/A)
`D
`E
`F (N/A)
`G
`
`Product Information/Prescribing Information
`Previous DMEPA Reviews
`Human Factors Study
`ISMP Newsletters
`FDA Adverse Event Reporting System (FAERS)*
`Other
`Labels and Labeling
`N/A=not applicable for this review
`*We do not typically search FAERS for our label and labeling reviews unless we are aware of
`medication errors through our routine postmarket safety surveillance
`
`FINDINGS AND RECOMMENDATIONS
`3
`Tables 2 and 3 below include the identified medication error issues with the submitted
`prescribing information, container labels, and carton labeling, DMEPA’s rationale for concern,
`and the proposed recommendation to minimize the risk for medication error.
`
`2
`
`Reference ID: 4452620
`
`

`

`RATIONALE FOR CONCERN
`
`The recommended dosage
`information for pediatric
`patients
`
` is based on
`kilogram body weight.
`
`Table 2: Identified Issues and Recommendations for Division of Antiviral Products
`Prescribing Information
`IDENTIFIED ISSUE
`Highlights of Prescribing Information (HPI)
`1.
`The dosage and administration
`section of the HPI states that the
`recommended dosage in pediatric
`
`patients
`is 150 mg to 400 mg. Inclusion
`of a dosage range (i.e., “150 mg to
`400 mg”) without reference to dose
`per kilogram of body weight could
`lead to misinterpretation or dosing
`errors.
`
`
`
`RECOMMENDATION
`
`We Recommend including an abbreviated
`recommended dosage table for the pediatric patient
`population in the HPI. For example, consider
`including:
`Recommended dosage in pediatric patients
`:
`
`
`
`Body Weight (kg)
`at least 35 kg
`
`Sofosbuvir Daily Dose
`400 mg once daily
`
`17 to less than 35 kg
`
`200 mg once daily
`
`Less than 17 kg
`
`150 mg once daily
`
`Refer to Table 2 of the full prescribing information for
`specific dosing guidelines. (2.3)
`Alternatively, if there are space limitations, we
`recommend revising the error-prone bulleted point in
`the HPI to read:
`Recommended dosage in pediatric patients
` Refer to Table 2 of the full
`prescribing information for specific dosing guidelines
`based on body weight. (2.3)
`
`
`
`Reference ID: 4452620
`
`3
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`Full Prescribing Information (FPI)
`1.
`Section 2.3 includes examples of
`non-acidic foods in which Sovaldi
`oral pellets can be administered
`
`
`
` We are
`concerned that this could lead to
`administration errors.
`
`Section 2.3 indicates that
`Sovaldi oral pellets is to be
`administered with non-acidic
`soft food
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`4
`
`Reference ID: 4452620
`
`(b) (4)
`
`
`
`(b) (4)
`
`(b) (4)
`
`

`

`1.
`
`Table 3: Identified Issues and Recommendations for Gilead Sciences, Inc (entire table to be conveyed to Applicant)
`Container Labels, Carton Labeling, and Packaging
`IDENTIFIED ISSUE
`RATIONALE FOR CONCERN
`
`The quantity statement
`The use of the phrase
`on the cartons for Sovaldi
`packets” is inconsistent with the Sovaldi
`oral pellets includes the
`oral pellets 400 mg dosage regimen that
`phrase
`
`requires administration of two 200 mg
`which could result in
`packets of pellets once daily.
`administration errors.
`
`RECOMMENDATION
`Revise the quantity statement to read: “28 packets”.
`
`2.
`
`The format of the
`expiration date is not
`defined on the container
`labels and carton
`labeling.
`
`We are unable to evaluate whether the
`proposed format of the expiration
`reduces the risk of deteriorated drug
`medication errors.
`
`Identify the expiration date format you intend to use.
`FDA recommends that the human-readable expiration
`date on the drug package label include a year, month,
`and non-zero day. FDA recommends that the
`expiration date appear in YYYY-MM-DD format if only
`numerical characters are used or in YYYY-MMM-DD if
`alphabetical characters are used to represent the
`month. If there are space limitations on the drug
`package, the human-readable text may include only a
`year and month, to be expressed as: YYYY-MM if only
`numerical characters are used or YYYY-MMM if
`alphabetical characters are used to represent the
`month. FDA recommends that a hyphen or a space be
`used to separate the portions of the expiration date.
`See Draft Guidance: Product Identifiers Under the Drug
`Supply Chain Security Act-Questions and Answers,
`September 2018 (lines 277-283) for further insight into
`FDA’s current thinking (found at:
`
`Reference ID: 4452620
`
`5
`
`(b) (4)
`
`(b) (4)
`
`

`

`https://www.fda.gov/ucm/groups/fdagov-
`public/@fdagov-drugs-
`gen/documents/document/ucm621044.pdf
`Ensure applicable container labels and carton labeling
`for Sovaldi meet the product identifier requirements
`of the Drug Supply Chain Security Act.
`
`3.
`
`The product identifier
`required under the Drug
`Supply Chain Security Act
`DSCSA) is missing from
`the container label of
`Sovaldi 200 mg tablets
`and the carton labeling of
`Sovaldi 150 mg and 200
`mg oral pellets.
`
`DSCSA requires certain prescription
`drugs to have a human-readable and
`machine-readable (2D data matrix
`barcode) product identifier on the
`smallest saleable unit for tracking and
`tracing purposes. In September 2018,
`FDA released draft guidance on product
`identifiers required under the Drug
`Supply Chain Security Act.a The Act
`requires manufacturers and repackagers,
`respectively, to affix or imprint a product
`identifier to each package and
`homogenous case of a product intended
`to be introduced in a transaction in(to)
`commerce beginning November 27,
`2017, and November 27, 2018,
`respectively.
`
`a The draft guidance is available from: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm621044.pdf
`
`6
`
`Reference ID: 4452620
`
`

`

`CONCLUSION
`4
`Our evaluation of the proposed prescribing information, container labels, and carton labeling
`identified areas of vulnerability that may lead to medication errors. Above, we have provided
`recommendations in Table 2 for the Division and Table 3 for the Applicant. We ask that the
`Division convey Table 3 in its entirety to the Applicant so that recommendations are
`implemented prior to approval of NDA 204671/S-014 and NDA 212480.
`
`7
`
`Reference ID: 4452620
`
`

`

`Active Ingredient
`Indication
`
`APPENDICES: METHODS & RESULTS FOR EACH MATERIAL REVIEWED
`APPENDIX A. PRODUCT INFORMATION/PRESCRIBING INFORMATION
`Table 2 presents relevant product information for Sovaldi received on March 14, 2019 from
`Gilead Sciences, Inc.
`Table 2. Relevant Product Information for Sovaldi
`Tablets: December 6, 2013
`Initial Approval Date
`Oral Pellets: N/A
`sofosbuvir
`Adult Patients:
`SOVALDI is indicated for the treatment of adult patients with
`chronic hepatitis C virus (HCV) infection as a component of a
`combination antiviral treatment regimen
`
`genotype 1 or 4 infection without cirrhosis or with
`compensated cirrhosis for use in combination with
`pegylated interferon and ribavirin
`genotype 2 or 3 infection without cirrhosis or with
`compensated cirrhosis for use in combination with
`ribavirin.
`Pediatric Patients:
`SOVALDI is indicated for the treatment of chronic HCV genotype 2
`or 3 infection in pediatric patients 3 years of age and older
`
` without cirrhosis or with compensated
`cirrhosis for use in combination with ribavirin.
`(proposed)
`
`
`
`Route of
`Administration
`Dosage Form
`Strength
`
`Dose and Frequency
`
`Oral
`
`Tablets; Oral pellets
`Tablets: 400 mg; 200 mg
`Oral pellets: 150 mg; 200 mg
`Adults:
` One 400 mg tablet once daily with or without food
`Pediatric Patients 3 years of Age and Older:
`
`8
`
`Reference ID: 4452620
`
`(b)
`(4)
`
`(b) (4)
`
`

`

`How Supplied
`
`Storage
`
`Container Closure
`
`Tablets:
`400 mg: bottles of 28 tablets with silica gel desiccant and polyester
`coil with a child-resistant closure
`200 mg: bottles of 28 tablets with polyester coil with a child
`resistant closure
`Oral Pellets: cartons containing 28 unit-dose packets
`Tablets: Store
` below 30 °C (86 °F). Dispense
`only in original container
`Oral pellets: Store
` below 30 °C (86 °F).
`Tablets: high density polyethylene (HDPE) bottle and a
` child-resistant cap lined
`with an induction activated aluminum foil liner
`Oral pellets: unit-dose packet comprised of
`
`
`
` that
`
`compliances with 16 CFR 1700.15
`
`9
`
`Reference ID: 4452620
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`APPENDIX B. PREVIOUS DMEPA REVIEWS
`On April 4, 2019, we searched for previous DMEPA reviews relevant to this current review using
`the terms, Sovaldi. Our search identified four previous reviewsb,c,d,e and we confirmed that our
`previous recommendations were implemented.
`
`b Wilson, V. Label and Labeling Review for Sovaldi (NDA 204671). Silver Spring (MD): FDA, CDER, OSE, DMEPA (US);
`2017 MAR 21. RCM No.: 2016-2825.
`c Calderon, M. Postmarketing Medication Error Review for Sovaldi (NDA 204671). Silver Spring (MD): FDA, CDER,
`OSE, DMEPA (US); 2014 SEP 22. RCM No.: 2014-857-1.
`d Calderon, M. Postmarketing Medication Error Review for Sovaldi (NDA 204671). Silver Spring (MD): FDA, CDER,
`OSE, DMEPA (US); 2014 MAY 30. RCM No.: 2014-857.
`e Walker, M. Label, Labeling, and Packaging Review for sofosbuvir NDA 204671. Silver Spring
`(MD): FDA, CDER, OSE, DMEPA (US); Insert Date 2013 SEP 23. RCM No.: OSE RCM 2013-874.
`10
`
`Reference ID: 4452620
`
`

`

`ISMP NEWSLETTERS
`APPENDIX D.
`D.1 Methods
`On April 4, 2019, we searched the Institute for Safe Medication Practices (ISMP) newsletters
`using the criteria below, and then individually reviewed each newsletter. We limited our
`analysis to newsletters that described medication errors or actions possibly associated with the
`label and labeling.
`ISMP Newsletters Search Strategy
`ISMP Newsletter(s)
`Acute Care ISMP Medication Safety Alert
`Community/Ambulatory Care ISMP Medication Safety Alert
`Nurse Advise-ERR
`Long-Term Care Advise-ERR
`ISMP Canada Safety Bulletin
`Pennsylvania Patient Safety Advisory
`
`Search Strategy and
`Terms
`
`Match Exact Word or Phrase: Sovaldi
`
`Results
`D.2
`The search retrieved no relevant articles associated with label and labeling for Sovaldi.
`
`11
`
`Reference ID: 4452620
`
`

`

`APPENDIX E. FDA ADVERSE EVENT REPORTING SYSTEM (FAERS)
`E.1 Methods
`On April 4, 2019, we searched FAERS using the criteria in the table below and identified 15
`cases. We individually reviewed the cases and limited our analysis to cases that described
`errors possibly associated with the label and labeling. We used the NCC MERP Taxonomy of
`Medication Errors to code the type and factors contributing to the errors when sufficient
`information was provided by the reporter.f We excluded 15 cases because they described
`missed dose(s) (n=10); accidental extra dose administered (n=1); insufficient information to
`determine if a medication error occurred (n=2); and duplicate reports (n=2).
`
`Criteria Used to Search FAERS
`Initial FDA Receive Dates:
`Product Name:
`
`Product Active Ingredient (PAI):
`Event:
`Country (Derived):
`
`January 7, 2017 to March 23, 2019
`Sovaldi
`Sovaldi Access
`
`SMQ Medication errors (Narrow)
`USA
`
`Results
`E.2
`Our search did not identify cases relevant to this label and labeling review.
`
`Description of FAERS
`E.3
`The FDA Adverse Event Reporting System (FAERS) is a database that contains information on
`adverse event and medication error reports submitted to FDA. The database is designed to
`support the FDA's postmarket safety surveillance program for drug and therapeutic biologic
`products. The informatic structure of the FAERS database adheres to the international safety
`reporting guidance issued by the International Conference on Harmonisation. FDA’s Office of
`Surveillance and Epidemiology codes adverse events and medication errors to terms in the
`Medical Dictionary for Regulatory Activities (MedDRA) terminology. Product names are coded
`using the FAERS Product Dictionary. More information about FAERS can be found at:
`http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseD
`rugEffects/default.htm.
`
`f The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Taxonomy of
`Medication Errors. Website http://www.nccmerp.org/pdf/taxo2001-07-31.pdf.
`
`12
`
`Reference ID: 4452620
`
`

`

`APPENDIX G. LABELS AND LABELING
`G.1
`List of Labels and Labeling Reviewed
`Using the principles of human factors and Failure Mode and Effects Analysis,g along with
`postmarket medication error data, we reviewed the following Sovaldi labels and labeling
`submitted by Gilead Sciences, Inc.
`
` Container labels received on February 28, 2019
`o Sovaldi Tablets, 200 mg
`o Sovaldi Tablets, 400 mg (current in-use container label)
`o Sovaldi Oral Pellets, 150 mg
`o Sovaldi Oral Pellets, 200 mg
`
`Packaging schematic for Sovaldi Oral Pellets received on February 28, 2019
` Carton labeling received on February 28, 2019
`o Sovaldi Oral Pellets, 150 mg
`o Sovaldi Oral Pellets, 200 mg
`Prescribing Information and Patient Information (Image not shown) received on March
`14, 2019. Available at: \\cdsesub1\evsprod\nda212480\0002\m1\us\114-
`labeling\draft\annotated\annotated-draft-labeling-text.pdf
`
`
`
`Label and Labeling Images
`G.2
`Container label for Sovaldi Tablets, 200 mg
`
`g Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
`
`13
`
`Reference ID: 4452620
`
`(b) (4)
`
`2 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS)
`immediately following this page
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`VALERIE S WILSON
`06/21/2019 01:24:54 PM
`
`SEVAN H KOLEJIAN
`06/21/2019 02:00:38 PM
`
`Reference ID: 4452620
`
`