Recruiting
`Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly
`Emetogenic Chemotherapy
`ClinicalTrials.gov ID NCT06065722
`SponsorSimon Williamson Clinic
`Information provided bySimon Williamson Clinic (Responsible Party)
`Last Update Posted 2023-10-10
`Study Details Tab
`Study Overview
`Brief Summary
`The purpose of the proposed study is to provide a clinical approach to chemotherapy induced nausea
`and vomiting (CINV) prophylaxis in cycle 2 of moderately emetogenic chemotherapy or highly
`emetogenic chemotherapy for patients who developed breakthrough CINV after cycle 1 based on the
`available data in the literature as well as the recommendations provided by established guidelines
`Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may
`affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific
`patient characteristics such as female gender, age, and history of low alcohol intake can increase a
`patients' risk for CINV.
`The U.S. government does not review or approve the safety and science of all studies
`listed on this website.
`Read our full disclaimer(https://clinicaltrials.gov/about-site/disclaimer) for details.
`Detailed Description
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 1/9
`HELSINN EXHIBIT 2028
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00948
`Page 1 of 9
`
`
`
`
`
`
`
`Table 1. Patient-Related Risk Factors for Emesis Following Chemotherapy Major Factors Minor Factors
`Female History of Motion Sickness Age < 50 years Emesis during past pregnancy History of prior low
`chronic alcohol intake (<1 ounce of alcohol/day) Anxiety History of previous chemotherapy-induced
`emesis
`Significant and uncontrolled CINV may result in patients returning to the chemotherapy treatment
`facility one to three days post-chemotherapy for rehydration, or emesis or nausea control. If CINV
`cannot be controlled in an outpatient facility, patients may subsequently be treated in an emergency
`department or require hospitalization. Patients who have an electrolyte imbalance or those who have
`recently undergone surgery or radiation therapy, are at greater risk of experiencing serious
`complications from CINV.
`The use of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists has improved the control of CINV
`Additional improvement in the control of CINV has occurred with the use of neurokinin-1 (NK-1)
`receptor antagonists, and olanzapine, an antipsychotic which blocks multiple neurotransmitters in the
`central nervous system.
`The primary endpoint used for studies evaluating various agents for the control of CINV has been
`complete response (CR) (no emesis, no use of rescue medication) over the acute (24 hours post-
`chemotherapy), delayed (24-120 hours), and overall (0-120 hours) periods. The combination of a 5-HT3
`receptor antagonist, dexamethasone, and a NK-1 receptor antagonist have improved the control of
`emesis in patients receiving either highly emetogenic chemotherapy (HEC) or moderately emetogenic
`chemotherapy (MEC) over a 120-hour period following chemotherapy administration
`The use of effective antiemetic agents in various clinical settings has been described in established
`guidelines from the Multinational Association of Supportive Care in Cancer (MASCC) and the European
`Society of Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO)], and the
`National Comprehensive Cancer Network (NCCN).
`The purpose of the proposed is to provide a clinical approach to CINV prophylaxis in cycle 2 of MEC or
`HEC for patients who developed breakthrough CINV after cycle 1 based on the available data in the
`literature as well as the recommendations provided by established guidelines.
`Official Title
`Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately
`or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy
`Conditions
`Chemotherapy Induced Nausea and Vomiting
`Intervention / Treatment
`Drug: Akynzeo
`Other Study ID Numbers
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 2/9
`Page 2 of 9
`
`
`
`
`
`
`
`Study Start (Actual)
`2023-09-09
`Primary Completion (Estimated)
`2023-12-31
`Study Completion (Estimated)
`2023-12-31
`Enrollment (Estimated)
`100
`Study Type
`Interventional
`Phase
`Phase 2
`Resource links provided by the National Library of Medicine
`MedlinePlus(https://medlineplus.gov/) related topics: Nausea and
`Vomiting(https://medlineplus.gov/nauseaandvomiting.html)
`Drug Information(https://dailymed.nlm.nih.gov/dailymed/) available for:
`Olanzapine(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Olanzapine)Olanzapine
`pamoate(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Olanzapine+pamoate)
`FDA Drug and Device Resources(https://clinicaltrials.gov/fda-links)
`Contacts and Locations
`This section provides contact details for people who can answer questions about joining this study, and
`information on where this study is taking place.
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 3/9
`Page 3 of 9
`
`
`
`
`
`
`
`To learn more, please see the Contacts and Locations section in How to Read a Study
`Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).
`This study has 1 location
`United States
`Alabama Locations
`Mount Olive, Alabama, United States, 35117
`Recruiting
`Rudolph M Navari
`Contact :Rudolph M Navari
`574-261-8385 rmnavari@gmail.com
`Contact :Rudolph M Navari
`5742618385 rmnavari@gmail.com
`Participation Criteria
`Researchers look for people who fit a certain description, called
`eligibility criteria. Some examples of
`these criteria are a person's general health condition or prior treatments.
`For general information about clinical research, read Learn About
`Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
`Study Contact
`Name: Rudolph M Navari
`Phone Number: 5742618385
`Email: rmnavari@gmail.com
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 4/9
`Page 4 of 9
`
`
`
`
`
`
`
`Eligibility Criteria
`Description
`Inclusion Criteria:
`CHEMOTHERAPY NAIIVE
`patient receiving moderately or highly emetogenic chemotherapy
`lung cancer
`breast cancer
`Exclusion Criteria:
`PRIOR CHEMOTHERAPY for any cancer
`nausea or vomiting 24 hours prior to study entry
`Ages Eligible for Study
`18 Years and older (Adult, Older Adult)
`Sexes Eligible for Study
`All
`Accepts Healthy Volunteers
`Yes
`Study Plan
`This section provides details of the study plan, including how the study is designed and what the study
`is measuring.
`How is the study designed?
`Design Details
`Primary Purpose : Supportive Care
`Allocation : Randomized
`Interventional Model : Parallel Assignment
`Masking : Double (Participant, Investigator)
`Masking Description: Double Blind
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 5/9
`Page 5 of 9
`
`
`
`
`
`
`
`What is the study measuring?
`Primary Outcome Measures
`Arms and Interventions
`Participant Group/ArmIntervention/Treatment
`Active Comparator:
`AKYNZEO for patient
`receiving MEC
`Add Akynzeo to 5HT3
`And dexamethasone
`Drug: Akynzeo
`OLANZAPINE
`Other Names:
`Olanzapine
`Active Comparator:
`oLANZAPINE and
`Akynzeo to patients
`receiving highly
`emetogenic
`olANZAPINE plus
`Akynzeo
`Drug: Akynzeo
`OLANZAPINE
`Other Names:
`Olanzapine
`Outcome
`Measure Measure Description Time
`Frame
`COMPELETE
`RESPONSE, no
`vomiting or use
`of rescue
`medications
`No vomiting or use of rescue medications for 5
`days post chemotherapy
`5 DAYS
`post
`chemot
`herapy
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 6/9
`Page 6 of 9
`
`
`
`
`
`
`
`Collaborators and Investigators
`This is where you will find people and organizations involved with this study.
`Simon Williamson Clinic
`Study Record Dates
`These dates track the progress of study record and summary results submissions to ClinicalTrials.gov.
`Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure
`they meet specific quality control standards before being posted on the public website.
`Study Registration Dates
`First Submitted
`2023-09-24
`First Submitted that Met QC Criteria
`2023-10-01
`First Posted
`2023-10-04
`Study Record Updates
`Last Update Submitted that met QC Criteria
`2023-10-08
`Last Update Posted
`2023-10-10
`Last Verified
`2023-09
`Sponsor
`Collaborators
`Helsinn Healthcare SA
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 7/9
`Page 7 of 9
`
`
`
`
`
`
`
`More Information
`Terms related to this study
`Plan for Individual Participant Data (IPD)
`Drug and device information, study documents, and helpful links
`Keywords Provided by Simon Williamson Clinic
`chemotherapy induced nausea and vomiting
`NK-1
`olanzapine
`Additional Relevant MeSH Terms
`Signs and Symptoms, Digestive
`Nausea
`Vomiting
`Antiemetics
`Autonomic Agents
`Peripheral Nervous System Agents
`Physiological Effects of Drugs
`Gastrointestinal Agents
`Antipsychotic Agents
`Tranquilizing Agents
`Central Nervous System Depressants
`Psychotropic Drugs
`Selective Serotonin Reuptake Inhibitors
`Neurotransmitter Uptake Inhibitors
`Membrane Transport Modulators
`Molecular Mechanisms of Pharmacological Action
`Neurotransmitter Agents
`Serotonin Agents
`Olanzapine
`Plan to Share Individual Participant Data (IPD)?
`No
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 8/9
`Page 8 of 9
`
`
`
`
`
`
`
`HHS Vulnerability DisclosureStudies a U.S. FDA-Regulated Drug Product
`Yes
`Studies a U.S. FDA-Regulated Device Product
`No
`Product Manufactured in and Exported from the U.S.
`No
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 9/9
`Page 9 of 9
`
`
`
`
`
`
`
`
`Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly
`Emetogenic Chemotherapy
`ClinicalTrials.gov ID NCT06065722
`SponsorSimon Williamson Clinic
`Information provided bySimon Williamson Clinic (Responsible Party)
`Last Update Posted 2023-10-10
`Study Details Tab
`Study Overview
`Brief Summary
`The purpose of the proposed study is to provide a clinical approach to chemotherapy induced nausea
`and vomiting (CINV) prophylaxis in cycle 2 of moderately emetogenic chemotherapy or highly
`emetogenic chemotherapy for patients who developed breakthrough CINV after cycle 1 based on the
`available data in the literature as well as the recommendations provided by established guidelines
`Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may
`affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific
`patient characteristics such as female gender, age, and history of low alcohol intake can increase a
`patients' risk for CINV.
`The U.S. government does not review or approve the safety and science of all studies
`listed on this website.
`Read our full disclaimer(https://clinicaltrials.gov/about-site/disclaimer) for details.
`Detailed Description
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 1/9
`HELSINN EXHIBIT 2028
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00948
`Page 1 of 9
`
`
`
`
`
`
`
`Table 1. Patient-Related Risk Factors for Emesis Following Chemotherapy Major Factors Minor Factors
`Female History of Motion Sickness Age < 50 years Emesis during past pregnancy History of prior low
`chronic alcohol intake (<1 ounce of alcohol/day) Anxiety History of previous chemotherapy-induced
`emesis
`Significant and uncontrolled CINV may result in patients returning to the chemotherapy treatment
`facility one to three days post-chemotherapy for rehydration, or emesis or nausea control. If CINV
`cannot be controlled in an outpatient facility, patients may subsequently be treated in an emergency
`department or require hospitalization. Patients who have an electrolyte imbalance or those who have
`recently undergone surgery or radiation therapy, are at greater risk of experiencing serious
`complications from CINV.
`The use of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists has improved the control of CINV
`Additional improvement in the control of CINV has occurred with the use of neurokinin-1 (NK-1)
`receptor antagonists, and olanzapine, an antipsychotic which blocks multiple neurotransmitters in the
`central nervous system.
`The primary endpoint used for studies evaluating various agents for the control of CINV has been
`complete response (CR) (no emesis, no use of rescue medication) over the acute (24 hours post-
`chemotherapy), delayed (24-120 hours), and overall (0-120 hours) periods. The combination of a 5-HT3
`receptor antagonist, dexamethasone, and a NK-1 receptor antagonist have improved the control of
`emesis in patients receiving either highly emetogenic chemotherapy (HEC) or moderately emetogenic
`chemotherapy (MEC) over a 120-hour period following chemotherapy administration
`The use of effective antiemetic agents in various clinical settings has been described in established
`guidelines from the Multinational Association of Supportive Care in Cancer (MASCC) and the European
`Society of Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO)], and the
`National Comprehensive Cancer Network (NCCN).
`The purpose of the proposed is to provide a clinical approach to CINV prophylaxis in cycle 2 of MEC or
`HEC for patients who developed breakthrough CINV after cycle 1 based on the available data in the
`literature as well as the recommendations provided by established guidelines.
`Official Title
`Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately
`or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy
`Conditions
`Chemotherapy Induced Nausea and Vomiting
`Intervention / Treatment
`Drug: Akynzeo
`Other Study ID Numbers
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 2/9
`Page 2 of 9
`
`
`
`
`
`
`
`Study Start (Actual)
`2023-09-09
`Primary Completion (Estimated)
`2023-12-31
`Study Completion (Estimated)
`2023-12-31
`Enrollment (Estimated)
`100
`Study Type
`Interventional
`Phase
`Phase 2
`Resource links provided by the National Library of Medicine
`MedlinePlus(https://medlineplus.gov/) related topics: Nausea and
`Vomiting(https://medlineplus.gov/nauseaandvomiting.html)
`Drug Information(https://dailymed.nlm.nih.gov/dailymed/) available for:
`Olanzapine(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Olanzapine)Olanzapine
`pamoate(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Olanzapine+pamoate)
`FDA Drug and Device Resources(https://clinicaltrials.gov/fda-links)
`Contacts and Locations
`This section provides contact details for people who can answer questions about joining this study, and
`information on where this study is taking place.
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 3/9
`Page 3 of 9
`
`
`
`
`
`
`
`To learn more, please see the Contacts and Locations section in How to Read a Study
`Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).
`This study has 1 location
`United States
`Alabama Locations
`Mount Olive, Alabama, United States, 35117
`Recruiting
`Rudolph M Navari
`Contact :Rudolph M Navari
`574-261-8385 rmnavari@gmail.com
`Contact :Rudolph M Navari
`5742618385 rmnavari@gmail.com
`Participation Criteria
`Researchers look for people who fit a certain description, called
`eligibility criteria. Some examples of
`these criteria are a person's general health condition or prior treatments.
`For general information about clinical research, read Learn About
`Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
`Study Contact
`Name: Rudolph M Navari
`Phone Number: 5742618385
`Email: rmnavari@gmail.com
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 4/9
`Page 4 of 9
`
`
`
`
`
`
`
`Eligibility Criteria
`Description
`Inclusion Criteria:
`CHEMOTHERAPY NAIIVE
`patient receiving moderately or highly emetogenic chemotherapy
`lung cancer
`breast cancer
`Exclusion Criteria:
`PRIOR CHEMOTHERAPY for any cancer
`nausea or vomiting 24 hours prior to study entry
`Ages Eligible for Study
`18 Years and older (Adult, Older Adult)
`Sexes Eligible for Study
`All
`Accepts Healthy Volunteers
`Yes
`Study Plan
`This section provides details of the study plan, including how the study is designed and what the study
`is measuring.
`How is the study designed?
`Design Details
`Primary Purpose : Supportive Care
`Allocation : Randomized
`Interventional Model : Parallel Assignment
`Masking : Double (Participant, Investigator)
`Masking Description: Double Blind
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 5/9
`Page 5 of 9
`
`
`
`
`
`
`
`What is the study measuring?
`Primary Outcome Measures
`Arms and Interventions
`Participant Group/ArmIntervention/Treatment
`Active Comparator:
`AKYNZEO for patient
`receiving MEC
`Add Akynzeo to 5HT3
`And dexamethasone
`Drug: Akynzeo
`OLANZAPINE
`Other Names:
`Olanzapine
`Active Comparator:
`oLANZAPINE and
`Akynzeo to patients
`receiving highly
`emetogenic
`olANZAPINE plus
`Akynzeo
`Drug: Akynzeo
`OLANZAPINE
`Other Names:
`Olanzapine
`Outcome
`Measure Measure Description Time
`Frame
`COMPELETE
`RESPONSE, no
`vomiting or use
`of rescue
`medications
`No vomiting or use of rescue medications for 5
`days post chemotherapy
`5 DAYS
`post
`chemot
`herapy
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 6/9
`Page 6 of 9
`
`
`
`
`
`
`
`Collaborators and Investigators
`This is where you will find people and organizations involved with this study.
`Simon Williamson Clinic
`Study Record Dates
`These dates track the progress of study record and summary results submissions to ClinicalTrials.gov.
`Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure
`they meet specific quality control standards before being posted on the public website.
`Study Registration Dates
`First Submitted
`2023-09-24
`First Submitted that Met QC Criteria
`2023-10-01
`First Posted
`2023-10-04
`Study Record Updates
`Last Update Submitted that met QC Criteria
`2023-10-08
`Last Update Posted
`2023-10-10
`Last Verified
`2023-09
`Sponsor
`Collaborators
`Helsinn Healthcare SA
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 7/9
`Page 7 of 9
`
`
`
`
`
`
`
`More Information
`Terms related to this study
`Plan for Individual Participant Data (IPD)
`Drug and device information, study documents, and helpful links
`Keywords Provided by Simon Williamson Clinic
`chemotherapy induced nausea and vomiting
`NK-1
`olanzapine
`Additional Relevant MeSH Terms
`Signs and Symptoms, Digestive
`Nausea
`Vomiting
`Antiemetics
`Autonomic Agents
`Peripheral Nervous System Agents
`Physiological Effects of Drugs
`Gastrointestinal Agents
`Antipsychotic Agents
`Tranquilizing Agents
`Central Nervous System Depressants
`Psychotropic Drugs
`Selective Serotonin Reuptake Inhibitors
`Neurotransmitter Uptake Inhibitors
`Membrane Transport Modulators
`Molecular Mechanisms of Pharmacological Action
`Neurotransmitter Agents
`Serotonin Agents
`Olanzapine
`Plan to Share Individual Participant Data (IPD)?
`No
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 8/9
`Page 8 of 9
`
`
`
`
`
`
`
`HHS Vulnerability DisclosureStudies a U.S. FDA-Regulated Drug Product
`Yes
`Studies a U.S. FDA-Regulated Device Product
`No
`Product Manufactured in and Exported from the U.S.
`No
`8/3/25, 4:08 PM Study Details | Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy | ClinicalTri…
`https://clinicaltrials.gov/study/NCT06065722 9/9
`Page 9 of 9
`
`
`
`
`
`
`
`
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