CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`212640Orig1s000
`
`CLINICAL REVIEW(S)
`
`
`
`
`
`
`
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`
`
`
`
`
`CLINICAL REVIEW
`Application Type 505 (b)(2)
`Application Number(s) 212640
`Priority or Standard Standard
`Receipt Date(s)
`01/31/2019
`PDUFA Goal Date 11/30/2019
`Division/Office Division of Neurology Products
`Reviewer Name(s) Rainer W. Paine, MD, PhD
`Review Completion Date 10/08/19
`Established Name Riluzole Oral Film
`(Proposed) Trade Name Exservan
`Applicant Aquestive Therapeutics
`Formulation(s) Oral Film, 50 mg of riluzole
`Dosing Regimen 50 mg every 12 hours
`Applicant Proposed
`
`Indication(s)/Population(s)
`Recommendation on
`Regulatory Action
`Recommended
`Indication(s)/Population(s)
`(if applicable)
`
`Amyotrophic lateral sclerosis (ALS)
`
`Approval
`Amyotrophic lateral sclerosis (ALS)
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`1
`
`
`
`Reference ID: 4515337Reference ID: 4525554
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`
`Table of Contents
`
`Glossary ........................................................................................................................................... 4
`
`1. Executive Summary ................................................................................................................. 6
` Product Introduction ........................................................................................................ 6
` Conclusions on the Substantial Evidence of Effectiveness .............................................. 6
` Benefit-Risk Assessment .................................................................................................. 7
`
`2. Therapeutic Context ................................................................................................................ 7
` Analysis of Condition ........................................................................................................ 7
` Analysis of Current Treatment Options ........................................................................... 7
`
`3. Regulatory Background ........................................................................................................... 8
`Summary of Presubmission/Submission Regulatory Activity .......................................... 8
`
`Foreign Regulatory Actions and Marketing History ......................................................... 8
`
`
`4. Sources of Clinical Data and Review Strategy ......................................................................... 9
` Table of Clinical Studies .................................................................................................... 9
` Review Strategy .............................................................................................................. 10
`
`5. Review of Relevant Individual Trials Used to Support Efficacy ............................................. 10
`
`
`
`6. Review of Safety .................................................................................................................... 10
`Safety Review Approach ................................................................................................ 10
`
` Review of the Safety Database ...................................................................................... 11
` Overall Exposure ..................................................................................................... 11
` Adequacy of the Safety Assessments ..................................................................... 11
`Safety Results ................................................................................................................. 11
` Deaths, Serious Adverse Events, and Significant Adverse Events ............................ 11
` Dropouts or Discontinuations Due to Adverse Effects ........................................... 11
` Adverse Events ........................................................................................................ 11
` Laboratory Findings ................................................................................................ 12
` Vital Signs ................................................................................................................ 12
` Swallowing Study 17MO1R-0012 ............................................................................ 13
`Safety in the Postmarket Setting.................................................................................... 14
`
`
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`2
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`Reference ID: 4515337Reference ID: 4525554
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
` Safety Concerns Identified Through Postmarket Experience ................................. 14
`Integrated Assessment of Safety ................................................................................... 14
`
`
`
`7.
`
`Labeling Recommendations .................................................................................................. 14
` Drug Labeling .................................................................................................................. 14
`
`8. Appendices ............................................................................................................................ 15
` References ...................................................................................................................... 15
`
`
`
`
`
`
`
`
`
`Table of Tables
`
`
`Table 1: Table of Clinical Studies .................................................................................................... 9
`Table 2: Treatment-Emergent Adverse Events and Number of Events Summarized per
`Treatment. Source: Study 162020 CSR ....................................................................................... 12
`Table 3: Penetration Aspiration Scale (PAS). VF = Vocal Folds ................................................... 13
`
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`3
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`
`
`Reference ID: 4515337Reference ID: 4525554
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`
`Glossary
`
`
`AC
`
`AE
`
`AR
`BA/BE
`BLA
`
`BPCA
`
`BRF
`
`CBER
`
`CDER
`
`CDRH
`
`CDTL
`
`CFR
`
`CMC
`
`COSTART
`CRF
`
`CRO
`
`CRT
`
`CSR
`
`CSS
`
`DMC
`
`ECG
`
`eCTD
`
`ETASU
`FDA
`
`FDAAA
`FDASIA
`GCP
`
`GRMP
`ICH
`
`IND
`
`iPSP
`
`ISE
`
`ISS
`
`ITT
`
`MedDRA
`mITT
`
`NCI-CTCAE
`
`advisory committee
`adverse event
`adverse reaction
`bioavailability and bioequivalence
`biologics license application
`Best Pharmaceuticals for Children Act
`Benefit Risk Framework
`Center for Biologics Evaluation and Research
`Center for Drug Evaluation and Research
`Center for Devices and Radiological Health
`Cross-Discipline Team Leader
`Code of Federal Regulations
`chemistry, manufacturing, and controls
`Coding Symbols for Thesaurus of Adverse Reaction Terms
`case report form
`contract research organization
`clinical review template
`clinical study report
`Controlled Substance Staff
`data monitoring committee
`electrocardiogram
`electronic common technical document
`elements to assure safe use
`Food and Drug Administration
`Food and Drug Administration Amendments Act of 2007
`Food and Drug Administration Safety and Innovation Act
`good clinical practice
`good review management practice
`International Council for Harmonization
`Investigational New Drug Application
`initial pediatric study plan
`integrated summary of effectiveness
`integrated summary of safety
`intent to treat
`Medical Dictionary for Regulatory Activities
`modified intent to treat
`National Cancer Institute-Common Terminology Criteria for Adverse Event
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`4
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`
`
`Reference ID: 4515337Reference ID: 4525554
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`NDA
`
`new drug application
`NME
`
`new molecular entity
`OCS
`
`Office of Computational Science
`OPQ
`
`Office of Pharmaceutical Quality
`OSE
`
`Office of Surveillance and Epidemiology
`OSI
`
`Office of Scientific Investigation
`PeRC
`
`Pediatric Review Committee
`PBRER
`Periodic Benefit-Risk Evaluation Report
`PD
`
`pharmacodynamics
`PI
`
`prescribing information or package insert
`PK
`
`pharmacokinetics
`PMC
`
`postmarketing commitment
`PMR
`
`postmarketing requirement
`PP
`
`per protocol
`PPI
`
`patient package insert
`PREA
`
`Pediatric Research Equity Act
`PRO
`
`patient reported outcome
`PSUR
`
`Periodic Safety Update report
`REMS
`risk evaluation and mitigation strategy
`RLD
`
`reference listed drug
`ROF
`
`riluzole oral film
`SAE
`
`serious adverse event
`SAP
`
`statistical analysis plan
`SGE
`
`special government employee
`SOC
`
`standard of care
`TEAE
`
`treatment emergent adverse event
`
`
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`5
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`Reference ID: 4515337Reference ID: 4525554
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`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`1. Executive Summary
`
`
`
`Product Introduction
`
`This application is for Exservan®, a new oral film formulation of riluzole. Riluzole (Rilutek®, 50
`mg tablets) was approved for the treatment of patients with amyotrophic lateral sclerosis
`(ALS) in 1995 under NDA 020599. The indication for riluzole oral film (ROF) is proposed to be
`the same as Rilutek®, treatment of patients with ALS. This application is a 505 (b)(2)
`application based on bioavailability and bioequivalence (BA/BE) studies to bridge the safety
`and efficacy of the new oral film formulation to the Reference Listed Drug (RLD), Rilutek®
`tablet.
`
`The recommended dosage for riluzole is 50 mg taken orally twice daily. A single unit of the
`oral film formulation of riluzole will provide an equivalent dose to the 50 mg tablet. Oral
`administration of the new formulation is by manual placement of the film on the top of the
`tongue. The film will then dissolve and be swallowed with saliva. Dilution with liquids is not
`necessary. The applicant purports that this dosage form will be easier to administer to ALS
`patients with oropharyngeal dysphagia because it would eliminate the need to crush
`Rilutek® tablets to powder and combine them with liquid.
`
`
`
`
`Conclusions on the Substantial Evidence of Effectiveness
`
`This is a 505 (b)(2) application based on a pivotal bioavailability and bioequivalence study to
`bridge the safety and efficacy of the new oral film formulation to the approved tablet dosage
`form of riluzole.
`
`
`The Office of Clinical Pharmacology review team has reviewed the results of this pivotal
`bioequivalence study (Study 162020) and recommends approval based on the bioequivalence
`demonstrated between 50 mg EXSERVAN® oral soluble film and the listed drug RILUTEK® oral
`tablet 50 mg (refer to Clinical Pharmacology Review).
`
`
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`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
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`6
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`Reference ID: 4515337Reference ID: 4525554
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`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`Benefit-Risk Assessment
`
`
`The overall benefit-risk assessment of the new oral film formulation of riluzole is unchanged
`from the approved tablets. Although oral hypoesthesia was observed after the
`administration of riluzole oral film (38%), there was no adverse effect on swallowing.
`
`
`
`2. Therapeutic Context
`
`
`
`Analysis of Condition
`
`Amyotrophic lateral sclerosis (ALS) is a rapidly progressive and fatal motor neuron
`disease. It is characterized by the gradual degeneration and death of the motor
`neurons responsible for voluntary control of muscles.
`
`ALS patients become progressively weaker, losing the ability to move their bodies.
`Respiratory muscles are also affected, leading to respiratory failure and the death of
`most patients within 3 to 5 years from the onset of symptoms. Approximately 10
`percent of ALS patients survive for 10 or more years. Shorter survival is associated
`with older age at onset, bulbar onset, and faster rate of respiratory dysfunction.
`
`The incidence of ALS is 2 per 100,000 per year with approximately 6000 new cases
`per year in the U.S. The estimated prevalence in the U.S. is 5 per 100,000
`population with approximately 16,000 cases. ALS most frequently affects people
`between 40 and 70 years of age (median age 55).
`
`
`
`Analysis of Current Treatment Options
`
`There is no cure for ALS. Most available treatments are intended to relieve
`symptoms, such as cramps and spasticity, and improve the quality of life. There
`are two FDA-approved treatments for ALS: riluzole (Rilutek), which prolongs
`survival by about 3 months and extends the time before ventilatory support is
`needed; and edaravone (Radicava), which demonstrated a 33% smaller functional
`decline compared to placebo after 24 weeks in patients within 2 years of
`diagnosis and with a forced vital capacity (FVC) of at least 80%. A new
`formulation of riluzole (Tiglutek oral suspension, NDA 209080) was approved in
`September 2018 through the 505(b)(2) pathway.
`
`
`
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`Version date: September 6, 2017 for all NDAs and BLAs
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`7
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`Reference ID: 4515337Reference ID: 4525554
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`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`3. Regulatory Background
`
`
`
`Summary of Presubmission/Submission Regulatory Activity
`
`Type B Pre-IND written responses were sent to the applicant on July 21, 2016. Clinical
`issues discussed included the need for assessment of chronic local oral cavity irritation
`in clinical studies and the need to assess swallowing in ALS patients after dosing with
`riluzole oral film. The applicant was also advised of the need to conduct a single dose,
`fasted state bioavailability/bioequivalence study and to evaluate food effect.
`IND 130939 for riluzole oral film in ALS was allowed to proceed on December 23, 2016.
`On November 22, 2017 the Pediatric Review Committee (PeRC) concurred with the
`initial pediatric study plan (iPSP) and the sponsor’s plan for a full waiver of pediatric
`studies.
`Type C written responses were sent to the applicant on March 21, 2018. The applicant was
`informed that a type 505(b)(2) NDA appeared acceptable and that the final study report for the
`swallowing study (17MO1R-0012) would need to be included in the NDA submission. The
`applicant was also advised that Study 17MO1R-0016 to assess chronic oral cavity irritation
`would not be needed because the adverse events reported for the pivotal BA/Food Effect Study
`162020 included only oral hypoesthesia and erythema with no other concerning findings of oral
`cavity irritation.
`
`
`
`
`On September 11, 2018, the applicant requested early termination of the swallowing study
`(17MO1R-0012) after interim analysis showed no adverse effect on swallowing from ROF. The
`Division granted the request on September 12, 2018.
`
`
`
`
`
`
`
`Foreign Regulatory Actions and Marketing History
`
`
`
`Riluzole oral film (Exservan®) is not approved or marketed in any country.
`
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`8
`
`
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`Reference ID: 4515337Reference ID: 4525554
`
`(b) (4)
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`4. Sources of Clinical Data and Review Strategy
`
` Table of Clinical Studies
`
`
`
`Table 1: Table of Clinical Studies
`
`Type of
`Study
`
`Phase 1
`Pilot
`BA/BE and
`Organolepti
`c Effect
`Study
`
`Study ID
`
`Study objective
`
`Study design
`
`Study drug,
`dose, route
`of
`administrati
`on
`
`No. of
`subjects
`
`Healthy
`subjects or
`diagnosis
`of patients
`
`Treatme
`nt
`duration
`
`1897
`
`PK and
`Organoleptic
`Effect
`
`Open-label, randomized,
`single-dose, 3-period, 4-
`arm, crossover, comparative
`bioavailability study under
`fasting conditions in healthy
`volunteers.
`
`
`Test:
`ROF 50 mg
`RLD:
`RILUTEK®
`50 mg oral
`tablet
`
`
`16
`
` Healthy
`Subjects
`
`Single doses
`x3, 7-day
`washout
`between
`doses
`
`162020
`
`
`Phase 1
`Pivotal
`BA/BE Study
`
`Primary:
`PK
`Secondary:
`Safety and
`Tolerability
`
`Open-label, randomized,
`single dose, five-period,
`replicate, crossover,
`comparative
`bioavailability study
`under fasting conditions
`in healthy volunteers.
`Subjects randomized to
`receive ABABC and
`BABAC.
`
`
`
`Test:
`ROF 50 mg
`RLD:
`RILUTEK®
`50 mg oral
`tablet
`
`Healthy
`Subjects
`
`Enrolled =
`32
`Complete
`d = 30
`
`Single doses
`x5, 7-day
`washout
`between
`doses
`
`
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`9
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`
`
`Reference ID: 4515337Reference ID: 4525554
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`Study objective
`Study ID
`
`Study design
`
`17M01R-
`0012
`
`Swallowing Safety
`and Tolerability
`
`Open-label, single-
`center, single-dose,
`safety and tolerability
`study
`
`Type of
`Study
`
`Phase 2
`Safety
`
`Study drug,
`dose, route
`of
`administrati
`on
`
`Test:
`ROF 50 mg
`
`
`No. of
`subjects
`
`Healthy
`subjects or
`diagnosis
`of patients
`
`Treatme
`nt
`duration
`
`9
`
`Subjects
`with ALS
`
`1 Visit
`
`
`
` Review Strategy
`
`This review only includes the safety review of the new riluzole oral film formulation.
`
`5. Review of Relevant Individual Trials Used to Support Efficacy
`
`This section is not applicable because this application is a 505 (b)(2) application based on a
`bioequivalence study to bridge the safety and efficacy of the new oral film formulation to
`the approved tablet dosage form. The applicant is relying on efficacy data from the already-
`approved RLD Rilutek (NDA 020599). The applicant has not conducted any studies of efficacy.
`6. Review of Safety
`
`The review of safety evaluated the three studies conducted by the applicant: pilot study 1897,
`pivotal study 162020, and swallowing safety study 17M01R-0012.
`
`
`
`
`Safety Review Approach
`
`The review attempted to identify any new safety signals from the submitted studies that could
`change the current safety profile of riluzole.
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`10
`
`
`
`Reference ID: 4515337Reference ID: 4525554
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`
`
`
`
`Review of the Safety Database
`
` Overall Exposure
`
`
`
`
`
`Forty-eight healthy volunteers were exposed to ROF 50mg in the pilot (n=16) and
`pivotal (n=32) studies. A total of 146 doses of ROF were administered to healthy
`volunteers (as well as 85 doses of Rilutek). In addition, 9 patients with ALS were
`exposed to one dose each of 50 mg ROF in the swallowing study (17MO1R-
`0012).
`
` Adequacy of the Safety Assessments
`
`
`The applicant’s safety assessments for this 505(b)(2) application appeared adequate.
`The clinical safety assessments included treatment-emergent adverse events, vital signs, and
`laboratory assessments.
`
`
`
`
`Safety Results
`
` Deaths, Serious Adverse Events, and Significant Adverse Events
`
`None.
`
` Dropouts or Discontinuations Due to Adverse Effects
`
`There were no dropouts or discontinuations in any of the three ROF clinical studies due to
`adverse effects.
`
` Adverse Events
`
`
`There were four adverse events in the pilot study 1897: two subjects with sleepiness in the
`ROF group and one subject with sleepiness and one with nausea in the Rilutek group.
`Adverse events from Study 162020 are shown in Table 2, copied from the submission and
`verified from the submitted data. Oral hypoesthesia occurred in both the fasting and fed
`riluzole oral film groups (38% and 10%, respectively) but not with Rilutek tablets. The
`intensities of the adverse events were mild. There were no adverse events reported for the
`swallowing safety and tolerability study 17M01R-0012.
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`11
`
`
`
`Reference ID: 4515337Reference ID: 4525554
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`
`Table 2: Treatment-Emergent Adverse Events and Number of Events Summarized per
`Treatment. Source: Study 162020 CSR
`
`
`
`
`
`
`
` Laboratory Findings
`
`There were no clinically significant shifts in any clinical chemistry or hematology parameters
`in any of the clinical studies. There were no Hy’s Law cases.
`
` Vital Signs
`
`No relevant differences in mean values and changes from baseline were observed for vital
`signs.
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`12
`
`
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`Reference ID: 4515337Reference ID: 4525554
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
` Swallowing Study 17MO1R-0012
`
`Swallowing study 17MO1R-0012 was a single site, single dose, open-label safety study in nine
`individuals with ALS.
`
`The following evaluations were included.
`•
`ALS Functional Rating Scale–Revised (ALSFRS-R).
`•
`Videofluoroscopic Swallowing Study (VFSS)
`•
`Episodes of penetration or aspiration quantified using the Penetration Aspiration Scale
`(PAS).
`
`The primary endpoint was the change in PAS Score on VFSS before and after a single dose of 50
`mg ROF. A PAS score of 1 or 2 indicates a safe swallow, 3-5 indicates penetration, and 6-8
`indicates aspiration. The following table, copied from the submission, describes the PAS.
`
`Table 3: Penetration Aspiration Scale (PAS). VF = Vocal Folds
`
`
`
`
`Analysis across each swallowing trial was performed, providing 12 bolus stimuli trials and
`approximately 35 swallows and PAS scores for each elicited swallow across testing within each
`participant.
`
`Five (56%) patients were able to swallow safely by PAS standards both pre- and post-dose. One
`patient moved from the “safe” to “penetration” category. No patient had a score indicative of
`CDER Clinical Review Template
`
`13
`Version date: September 6, 2017 for all NDAs and BLAs
`
`
`
`Reference ID: 4515337Reference ID: 4525554
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`aspiration either pre- or post-dose. Seven patients (78%) had the same summed score pre- and
`post- dose, while 2 patients (22%) improved their score. There were no patients whose sum of
`scores was worse following dosing.
`
`
`
`Safety in the Postmarket Setting
`
` Safety Concerns Identified Through Postmarket Experience
`
`
`Based on the Periodic Safety Update (PSUR) for Rilutek® between 12/17/17 and 11/12/18, no
`new safety concern or risk was identified except for two cases of acute pancreatitis.
`Published literature review also identified a journal article describing two cases of acute
`pancreatitis associated with riluzole use (de Campos & de Carvalho, 2017). Pancreatitis was
`identified in the original riluzole clinical studies as an infrequent adverse event, occurring in
`1/100 to 1/1000 patients. Pancreatitis is not mentioned in the current riluzole label.
`
`
`
`
`
`
`
`
`Integrated Assessment of Safety
`
`
`Oral hypoesthesia occurred in both the fasting and fed riluzole oral film groups (38% and 10%,
`respectively) but not with Rilutek tablets in the pivotal study 162020. There was no evidence
`that oral hypoesthesia adversely affected swallowing safety. There are no other new safety
`findings for riluzole except for two cases of acute pancreatitis reported in the postmarket
`setting which will be further investigated for potential inclusion in a future label revision.
`
`
`7. Labeling Recommendations
`
` Drug Labeling
`
`This reviewer recommends adding additional information to Section 6 of the label about the
`rate of oral hypoesthesia observed with ROF (38%) compared to no patients with Rilutek in
`the pivotal study 162020.
`
`
`
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`14
`
`
`
`Reference ID: 4515337Reference ID: 4525554
`
`(b) (4),
`(b) (5)
`
`

`

`Clinical Review
`Rainer W. Paine, MD, PhD
`NDA 212640
`Exservan (Riluzole Oral Film)
`8. Appendices
`
` References
`
`
`de Campos, C., & de Carvalho, M. (2017)
`Riluzole-induced recurrent pancreatitis
`Journal of Clinical Neuroscience 45: 153–154
`
`
`CDER Clinical Review Template
`Version date: September 6, 2017 for all NDAs and BLAs
`
`15
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`Reference ID: 4515337Reference ID: 4525554
`
`

`

`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/
`------------------------------------------------------------
`
`RAINER PAINE
`11/04/2019 12:48:11 PM
`
`TERESA J BURACCHIO
`11/04/2019 01:24:54 PM
`
`
`
`Reference ID: 4515337Reference ID: 4525554
`
`