CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICATION NUMBER:
`
`022063Orig1s000
`
`SUMMARY REVIEW
`
`KVK-TECH EXHIBIT 1051
`
`

`

`Cross Discipline Team Leader Review
`
`Cross—Discipline Team Leader Review
`
`
`Date
`June 19, 2017
`
`From
`Sub'ect
`
`NDA/BLA #
`
`Su n lement#
`
`CDR Javier A. Mufiiz, MD
`Cross-Disci o line Team Leader Review
`
`NDA 022063
`
`
`
`Shire Develo ment, LLC
`A licant
`
`Date of Submission
`December 20, 2016
`
`PDUFA Goal Date
`
`June 20, 2017
`
`Proprietary Name /
`Established (USAN) names
`
`Mydayis
`Mixed salts of a single-entity amphetamine extended-
`release ca u sules
`
`Dosa_e forms / Stren_ h
`
`Proposed Indication(s)
`
`Recommended:
`
`For the treatment of Attention Deficit Hyperactivity
`Disorder in
`1. Adults
`2. Children (ogjears old and older
`A .roval
`
`1. Introduction and Background
`
`This NDA is a Class 2 Resubmission for SHP465 by Shire (the Applicant). SHP465 (proposed
`trade name: Mydayis; previously known as SDP465) is an single-entity mixed amphetamine
`salt (MAS) extended-release capsule developed for the treatment of Attention Deficit
`Hyperactivity Disorder (ADI-ID) in adults and children (“3 years old and above. SHP465 is an
`extended-release formulation of the same mix of amphetamine salts that is the active
`component of the approved amphetamine products Adderall (NDA 011522) and Adderall XR
`(NDA 021303), also owned by the Applicant.
`
`The rationale for this formulation is to extend the benefits from the 12-hour duration for
`
`Adderall XR to 16 hours for this product. Drug use data suggests that some patients with
`ADI-1]) require an additional dose of immediate release GR) amphetamine 8-10 hours after an
`Adderall XR dose to extend the therapeutic benefits of these drugs into the evening. This
`product is intended to provide a convenient single formulation to meet this need.
`
`SHP465 contains three different beads: an IR bead, and two timed-release beads that are
`intended to release active drug at different rates to cover the 16-hour time period. The
`Applicant’s proposed dose range is 12.5-50mg/day, and the available strengths would be 12.5,
`25, 37.5, and 50mg.
`
`This resubmission is a complete response to an approvable letter issued for this NDA in May
`2007. The approvable letter tentatively approved 12.5 and 25mg SHP465 for the treatment of
`ADHD. The Applicant notified the Agency in 2007 that they intended to file an amendment to
`support approval; however, they later decided not to pursue further development of SHP465
`
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`Cross Discipline Team Leader Review
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`for business reasons. In recent years, the Applicant reactivated the development program for
`proposed product and is currently seeking approval for the treatment of ADHD. The clinical
`development program consisted of 16 clinical studies, 13 of which were included in the
`original NDA (doses starting at 12.5mg up to
`, and three of which (i.e., one
`pharmacokinetic trial in pediatric patients aged 6-17 years, one efficacy and safety trial in
`pediatric patients aged 6-17 years, and one efficacy and safety trial in adults aged 18-55 years)
`are new and included in this resubmission. A population pharmacokinetic (PK) analysis report
`was also included in this resubmission.
`
`
`2. CMC/Device
`An approval recommendation was made from a CMC perspective during the original NDA
`review; however, an approvable action was taken in 2007 partly because of deficiencies related
`to the drug product dissolution method. In this resubmission these deficiencies were
`adequately addressed. Several manufacturing and control changes were made since the
`previous submission and data were provided which supported these changes. A drug product
`expiry period of 24 months was found acceptable.
`
` drug product manufacturing site found that the drug
`The preapproval inspection of the
`substance analytical methods were not transferred from the
` drug substance
`manufacturing sites. Method transfer and validation data did not completely meet Agency
`GMP expectations. This was determined to be a low risk issue and the site was found to be
`acceptable to support this application.
` is expected to continue working this issue and
`the Office of Regulatory Affairs (ORA) will ensure that this is addressed in this site’s next
`inspection.
`
`Of note, the non-proprietary name for this product will be (mixed salts of a single-entity
`amphetamine product) extended-release capsules, which is identical to Adderall XR’s non-
`proprietary name. It is also noted that Adderall XR and this new product have an overlapping
`25mg dosage strength. This increases the potential for confusion and prescribing errors. The
`labeling groups at the Officer of Pharmaceutical Quality (OPQ) and the Office of Generic
`Drugs (OGD) as well as the Division of Medication Error Prevention and Analysis (DMEPA)
`were made aware of this during the review process although the Agency has requested that the
`Applicant propose ways to distinguish these products since at least the 2007 action letter.
`Additional labeling elements will be required to distinguish this product from Adderall XR
`(e.g., including proprietary name, ancillary carton statements, capsule colors and markings,
`NDC number, etc.). The OGD labeling team acknowledged this issue but did not have any
`recommendations on non-proprietary name alternatives.
`
`In summary, the Applicant has resolved the drug product dissolution deficiencies and
`demonstrated the capability of manufacturing a product of adequate quality. The OPQ team
`recommends approval of this resubmission.
`
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`Cross Discipline Team Leader Review
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`3. Nonclinical Pharmacology/Toxicology
`The original application was considered approvable pending the incorporation of the findings
`from additional nonclinical studies (pre- and postnatal developmental reproductive toxicology
`study and the juvenile animal study) into the drug’s label. All nonclinical issues have been
`addressed and the nonclinical team has made recommendations for the updated product label.
`
`Based on the long history of clinical use of the active ingredients and the supporting
`
`nonclinical studies that demonstrate the lack of systemic absorption of a
`excipient used in this formulation
` the nonclinical reviewer, Deepa Rao,
`PhD, recommends approval of this resubmission.
`
`4. Clinical Pharmacology/Biopharmaceutics
`The Office of Clinical Pharmacology (OCP) team recommends approval of this resubmission
`only for patients aged 13 and older. The OCP team agrees with the recommended starting dose
`of 12.5mg once daily in the morning for adults and pediatric patients 13 -17 years old who are
`either starting treatment for the first time or switching from another medication regimen.
`Dosage may be adjusted in increments of 12.5mg no sooner than weekly up to a maximum
`dose of 50mg/day, based on the therapeutic needs and response in adult patients. The
`maximum dose in pediatric patients is 25mg/day.
`
`This resubmission included Study SHP-111, a Phase 1, open-label study of the PK parameters
`of d- and l-amphetamine after a single oral dose of SHP465 12.5mg or 25mg administered to
`children and adolescents aged 6 to 17 years with ADHD. A single dose of 12.5mg SHP465
`produced higher d-amphetamine Cmax and AUC0-24 values in children six to 12 years of age
`than in adults (Figure 1 and Figure 2). The same trend of higher Cmax and AUC0-24 in pediatric
`patients six to 12 years of age compared to adults is seen for the l-amphetamine isomer.
`
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`Cross Discipline Team Leader Review
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`Figure 1: Comparison of d-amphetamine Cmax Distribution Following a Single 12.5mg
`Capsule Administered to Adults or Pediatric Patients Age 7 to 12 Years
`
`[Source: OCP review, Figure 2, page 14]
`Adult data from Studies 107 and 110. Pediatric data from Study 111.
`
`Figure 2: Comparison of d-amphetamine AUC0-24 Distribution Following a Single 12.5mg
`Capsule Administered to Adults or Pediatric Patients Age 7 to 12 Years
`
`[Source: OCP review, Figure 2, page 14]
`Adult data from Studies 107 and 110. Pediatric data from Study 111.
`
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`Cross Discipline Team Leader Review
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`From Study 111, there is a higher incidence of insomnia and loss of appetite in pediatric
`patients aged 6-12 years old compared to adults or pediatric patients aged 13-17 years (see
`Section 7). Unfortunately, there is insufficient data to formally assess the relationship between
`the observed adverse event rate and amphetamine exposure as PK data were not collected in
`the Phase 3 trials.
`
`A reduced starting dose for pediatric patients six to 12 years of age is not feasible because no
`dose lower than 12.5mg is available. In addition, it is not appropriate to recommend
`consuming half of a capsule as there is no guarantee that the split would result in an even
`distribution of each of the three types of beads inside each capsule. Furthermore, the OCP
`team recommends that the Applicant develop a lower dosage strength (i.e., 6.25mg) post-
`approval.
`
`Finally, the OCP team recommends a postmarketing requirement to conduct a PK study in
`children 4-5 years old; however, I can agree with this recommendation only after a lower
`dosage has been developed.
`
`5. Clinical Microbiology
`Not applicable.
`
`6. Clinical/Statistical- Efficacy
`SHP465 demonstrated robust efficacy in both the adult and pediatric populations. This
`resubmission contained new efficacy data in studies SHP465-306 and 305. In adults (Study
`SHP465-306) the reduction from baseline in Attention Deficit Hyperactivity Disorder Rating
`Scale (ADHD-RS) with prompts total score was significantly greater in the SHP465 12.5mg
`and the SHP465 37.5mg treatment groups compared with the placebo treatment group
`(p<0.001). In pediatric patients (Study SHP465-305) the reduction from baseline in Attention
`Deficit Hyperactivity Disorder Rating Scale, DSM-IV version (ADHD-RS-IV) total score was
`significantly greater in the SHP465 treatment group (12.5 or 25mg) compared with the placebo
`treatment group (p<0.001).
`
`The Applicant proposed labeling claims for SHP465 in the following dose strengths: 12.5, 25,
`37.5, and 50mg. The efficacy of the 50mg dose was established in two adult Phase 3 trials
`(SHP465-301 and 303) reviewed in the original NDA by Dr. Mark Ritter. Study 303 evaluated
`SHP465’s dose response, including the 50mg and 75mg strengths. The 75mg dose failed to
`provide significant efficacy advantages and had a less favorable safety profile than the 50mg
`dose. Hence, the Agency required Shire to evaluate a new lower dose in adults (i.e., 12.5mg) in
`study 306.
`
`Study 306 was a Phase 3, randomized, double-blind, multicenter, placebo-controlled, forced-
`dose titration, safety and efficacy study of SHP465 in adults aged 18-55 years with ADHD. In
`order to be enrolled, patients must have had a baseline score of ≥ 28 on the adult ADHD-RS
`with prompts (total score). This four-week study consisted of four periods: Screening and
`
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`Cross Discipline Team Leader Review
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`washout, forced-dose titration (two weeks), dose maintenance (two weeks), and safety follow-
`up. The patients were randomized to 12.5mg group, forced-dose titration group up to 37.5mg,
`or placebo. Study 305 was a Phase 3, randomized, double-blind, multicenter, placebo-
`controlled, dose-optimization, safety and efficacy study of SHP465 in children and adolescents
`aged 6-17 years with ADHD. Patients must have had a baseline score of ≥ 28 on the ADHD-
`RS-IV total score to be enrolled. This was also a four-week study consisting of four periods:
`Screening and washout, dose-optimization titration (one week), dose maintenance (three
`weeks), and safety follow-up. The patients were randomized to SHP465 12.5mg then dose-
`optimized to 25mg group or placebo. Both studies were conducted in the US. Figure 3 shows
`the schematics for both studies.
`
`Figure 3: Study Design Flow Chart (SHP465-306 and 305)
`
`[Source: Derived from 5.3.5.1 Protocols for SHP465-306 and 305]
`
`Overall, the demographic data in both studies was generalizable to the US ADHD population.
`In Study 306, there were 80 subjects (89.9%) in the placebo treatment group, 80 subjects
`(87.0%) in the SHP465 12.5mg treatment group, and 76 subjects (84.4%) in the SHP465
`37.5mg treatment group who completed the study. The most common reasons for early
`termination were adverse events occurring in seven subjects in the SHP465 12.5mg treatment
`group and five subjects in the SHP465 37.5mg treatment group. In Study 305, there were 118
`subjects (90.1%) in the placebo treatment group and 116 subjects (87.9%) in the SHP465
`treatment group who completed the study. The most common reasons for early termination
`were lack of efficacy (N=4) in the placebo treatment group and adverse events (N=11) in the
`SHP465 treatment groups.
`
`A summary of the primary efficacy results for Study 306 is presented in Table 1.
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`Table 1: Summary of Primary Endpoint Statistics; Study SHP465-306
`Treatment Group
`SHP465 12.5 mg
`(N=89)
`
`Placebo
`(N=86)
`
`SHP465-306
`Statistic
`Number of subjects with observations
`at Visit 6 (Week 4)
`Mean change from baseline (SD)
`LS mean change from baseline
`Difference of LS mean change from
`baseline (95% CI) SHP465 vs
`placebo
`Effect size
`p-value
`[Source: 5.3.5.1 SHP465-306 Study Report Body, page 68]
`
`77
`
`-11.0 (11.47)
`-10.4
`
`SHP465 37.5 mg
`(N=88)
`
`78
`
`-18.1 (13.42)
`-18.5
`
`73
`
`-23.8 (11.89)
`-23.8
`
`-8.1 (-11.7, -4.4)
`
`-13.4 (-17.1, -9.7)
`
`0.67
`p<0.001
`
`1.11
`p<0.001
`
`Similarly, the primary efficacy results of Study 305 are summarized in Table 2.
`
`Table 2: Summary of Primary Endpoint Statistics; Study SHP465-305
`Treatment Group
`Placebo
`SHP465
`(N=129)
`(N=128)
`113
`-21.5 (11.53)
`-20.7
`
`117
`-11.7 (13.37)
`-10.8
`
`-9.9 (-13.0, -6.8)
`
`0.80
`<0.001
`
`SHP465-305
`Statistic
`
`Number of subjects with observations at Visit 6 (Week 4)
`Mean change from baseline (SD)
`LS mean change from baseline
`Difference of LS mean change from baseline (95% CI)
`SHP465 vs placebo
`Effect size
`p-value
`[Source: 5.3.5.1 SHP465-305 Study Report Body, page 71]
`
`The key secondary endpoint for studies SHP465-306 and 305 was the CGI-I. In Study 306,
`CGI-I scores at Visit 6 (Week 4) for the SHP465 12.5mg and SHP465 37.5mg treatment
`groups were significantly lower, indicating greater improvement, compared with the placebo
`treatment group (p<0.001). The difference in LS mean (95% CI) was -0.8 (-1.1, -0.4) and the
`effect size was 0.68 for the SHP465 12.5mg treatment; the difference in LS mean (95% CI)
`was -1.2 (-1.6, -0.9) for the SHP465 37.5mg treatment and the effect size was 1.11, both
`favoring SHP465 treatment. For Study 305, the CGI-I score at Visit 6 (Week 4) for the
`SHP465 treatment group was significantly lower compared with the placebo treatment group
`(p<0.001). The difference in LS mean (95% CI) was -0.8 (-1.1, -0.5), and the effect size was
`0.65, also favoring SHP465 treatment. No other endpoints were analyzed for either study.
`
`The biostatics reviewer, Yang Wang, PhD, replicated the Applicant’s efficacy and sensitivity
`analyses and agrees that both studies demonstrate that SHP465 is statistically significant
`superior to placebo in the treatment of ADHD as measured by the primary and key secondary
`endpoints. The statistical efficacy results provide adequate evidence to support a claim of
`
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`Cross Discipline Team Leader Review
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`SHP465’s favorable effect at dose levels of 12.5 mg and 37.5 mg in adults and at a dose range
`between 12.5 and 25 mg in children and adolescents aged 6-17 for the treatment of ADHD. Dr.
`Wang recommends approval of this resubmission.
`
`7. Safety
`Nancy Dickinson, PharmD, was the clinical reviewer for this resubmission; she recommends
`approval for patients 13 years of age and older.
`
`There were no deaths in Study 306 (adults) or Study 305 (pediatric). There were no serious
`adverse events (SAEs) in the adult study but there was one case of a suicidal attempt in Study
`305 in a 16-year-old female with a history of depression.
`
`In her review, Dr. Dickinson notes a high incidence of insomnia and decreased appetite in
`Study 305. In general, the younger age cohort of pediatric patients (6 to 12 years) was more
`susceptible to adverse events than the 13 to 17 year old cohort. Decreased appetite occurred in
`43% of the 6 to 12 year olds and that weight decreased in three patients. When considering
`appetite suppression and weight loss, it is important to note that Study 305 was only a 4-week
`trial and that these children are expected to gain weight as they grow. Because SHP465 will be
`used chronically in these patients, it is important to consider the effects of decreased appetite
`and weight loss in long-term growth suppression. Although growth suppression and decreased
`appetite are well-known problems with stimulants, SHP465 with its 16-hour effects appears to
`have a more pronounced effect in reducing appetite than shorter-acting stimulants. It should be
`noted that growth suppression is not expected to be seen in studies shorter than six months or
`longer. In the 13-17 year old cohort, the incidence of decrease appetite was 21.8% in patients
`receiving SHP465 compared to 6.3% in patients receiving placebo. Similarly, insomnia
`occurred in 27.8% of patients on SHP465 vs. 1.9% of placebo patients in the 6-12 years-old
`cohort. In contrast, insomnia occurred at only twice the rate of placebo (5.1%) in adolescents
`aged 13-17. The Applicant states that the insomnia is time limited. However, it had great
`enough impact that one patient dropped out due to insomnia and another patient dropped out
`due to a seizure (sleep deprivation is known to reduce the seizure threshold).
`
`As previously noted, studies 301 and 303 were reviewed during the initial NDA application.
`Dr. Dickinson pooled the data from these two studies with Study 306 in order to better
`characterize the safety profile of SHP465 in adults. Overall, the profile of common adverse
`events seen with SHP465 was similar to that observed with other stimulants (e.g., insomnia,
`anxiety, modest tachycardia, decreased appetite and weight, modest increase in blood pressure,
`palpitations, GI distress, etc.).
`
`In summary, with the exception of a higher-than-expected incidence of insomnia and
`decreased appetite in children 6-12 years old, the safety data submitted with this application
`are consistent with the known safety profile of the active moiety. Dr. Dickinson’s review
`revealed no safety findings that would require a labeling revision for products containing
`mixed salts of a single-entity amphetamine, preclude approval of this application, or
`necessitate other regulatory action.
`
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`8. Advisory Committee Meeting
`No advisory committee meeting was held for the original application or for this resubmission.
`The evaluation of the safety data did not reveal particular safety issues that were unexpected
`for this class, and the design and results of the efficacy trial did not pose particular concerns.
`
`9. Pediatrics
`The Applicant has submitted a single-dose PK study and a safety and efficacy study in
`children 6-17 years old with this resubmission. During the course of this review, the Applicant
`submitted their Proposed Pediatric Study Plan (PPSR) to study SHP465 in children 4-5 years
`of age, seeking for the Agency to issue a Pediatric Written Request (PWR) for the study.
`However, because of the high incidence of appetite suppression and insomnia seen in the 6-12
`year-old patients in Study 305, we would require a lower dose of SHP465 (6.25mg) be
`developed and studied in this population prior to issuing a PWR for children 4-5 years old.
`Therefore, we are deferring submission of the pediatric studies for ages 4 to 5 years for this
`application. We are also waiving the pediatric study requirement for ages 0 to 3 years because
`necessary studies are impossible or highly impracticable. The pediatric postmarketing
`requirements will be discussed in the next section.
`
`Other Relevant Regulatory Issues
`10.
`Study Site Inspections:
`Four study sites were inspected by the Office of Scientific Investigations (OSI). These sites
`were identified for a Good Clinical Practices (GCP) audit based on relative importance of the
`study to the NDA and on the number of subjects per site. All inspected sites have received a
`preliminary No Action Indicated (NAI) classification. No special concerns were identified for
`protocol violations or investigators’ conflict of interests. Overall, the data submitted by the
`Applicant in support of this application are acceptable.
`
`Postmarketing Requirements:
`The following postmarketing requirements (PMRs) are requested by the review team and will
`be conveyed to the Applicant in the Approval Letter:
`
`3224-1
`
`A single-dose, open-label, randomized pharmacokinetic study of SHP465 in
`male and female children (four to less than six years of age) with ADHD.
`
`Final Protocol Submission:
`Study/Trial Completion:
`Final Report Submission:
`
`09/01/2017
`12/31/2018
`06/30/2019
`
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`3224-2
`
`A 4-week, randomized, double-blind, placebo-controlled, fixed-dose study of
`SHP465 6.25mg in 4-5 year olds diagnosed with ADHD.
`
`Final Protocol Submission:
`Study/Trial Completion:
`Final Report Submission:
`
`09/01/2017
`12/31/2018
`06/30/2019
`
`3224-3
`
`Because of adverse reactions identified during your development program, it is
`not apparent from the studies you have conducted in six to 12 year old patients
`with ADHD that the lowest effective dose of SHP465 has been identified.
`
`Conduct a 4-week, randomized, double-blind, placebo-controlled, flexible-dose
`titration study of SHP465 6.25 and 12.5mg in six to 12 year olds diagnosed
`with ADHD.
`
`Final Protocol Submission:
`Study/Trial Completion:
`Final Report Submission:
`
`09/01/2017
`12/31/2018
`06/30/2019
`
`3224-4
`
`A one year Pediatric Open-Label Safety Study for patients aged four to 12 years
`(at the time of entry into PMR 3224-1, PMR 3224-2, or PMR 3224-3) with
`ADHD.
`
`Final Protocol Submission:
`Study/Trial Completion:
`Final Report Submission:
`
`09/01/2018
`12/31/2019
`06/30/2020
`
`Non-proprietary name considerations:
`The non-proprietary name for this product will be (mixed salts of a single-entity amphetamine
`product) extended-release capsules, which is identical to Adderall XR’s non-proprietary name.
`This can potentially lead to confusion and medication errors. This was discussed in Section 2.
`
`Labeling
`11.
` The Applicant has requested for
`The original proposed trade name for SHP465 was
`the trade name to be changed to Mydayis; this is acceptable to the Agency.
`
`Labeling was updated to include a description of studies 305 and 306 in the Clinical Studies
`section and less relevant trials were removed from the original label. Revisions to language
`were made throughout the label for clarity and class labeling consistency, including an
`amphetamine class warning about the risk of lowering seizure threshold (there was one seizure
`in a patient with no prior history in Study 305). The Medication Guide (MG) was also revised
`for clarity.
`
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`Cross Discipline Team Leader Review
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`Importantly, the review team recommends a Limitations of Use (LOU) in patients 12 years and
`younger because they experienced higher plasma exposure than patients 13 years and older at
`the same dose, and they experienced higher rates of adverse reactions, mainly insomnia and
`decreased appetite. I agree with the review team’s recommendation on this LOU and it has
`been negotiated into labeling.
`
`Recommendations/Risk Benefit Assessment
`12.
`Sufficient information has been submitted to conclude that SHP465 is safe and effective for
`the treatment of ADHD patients 13 years old and older. As previously discussed, drug use data
`suggests that some patients with ADHD require an additional dose of immediate release (IR)
`amphetamine 8-10 hours after an Adderall XR dose to extend the therapeutic benefits of these
`drugs into the evening. This product is intended to provide a convenient single formulation to
`meet this need. No new safety signals were identified in the development program that would
`alter the overall benefit-risk assessment for products containing mixed salts of a single-entity
`amphetamine (i.e., Adderall, Adderall XR, and SHP465). The label and Medication Guide
`have been negotiated to current Division standards. This application should be approved by the
`PDUFA date.
`
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JAVIER A MUNIZ
`06/20/2017
`
`MITCHELL V Mathis
`06/20/2017
`
`Reference ID: 4113941
`
`