Table of Contents
Picovir ? (Pleconaril)
Agenda
Clinical Development Program
Application Issues
Overall Study Results
Patient Subgroups
Possible Analysis Populations
Identification of Infected Patients
TaqMan RT-PCR Assay
Fluorescence versus Cycle
ELOSA RT-PCR Assay
TaqMan and ELOSA Gel Analysis
Viral Culture
Resistance in Pivotal Studies
Time to Primary Endpoint Treatment Emergent Resistance
Time to Primary Endpoint Baseline Lack of Susceptibility
Food Effect
Safety
Pleconaril Adult Phase 2 7-day Treatment Studies
Phase 2 Limitations
Studies 843-043 and 843-044 Design
Studies 843-043 and 843-044 Design
Studies 843-043 and 843-044 Design
Studies 843-043 and 843-044 Demographics (ITT)
Pleconaril Efficacy Results
Phase 2 and 3 Clinical Trials
PCR and Culture Status (Trial 43)
PCR and Culture Status (Trial 44)
Quartiles of Time to Healing PCR+ Patients (ITT-I)
Quartiles of Time to Healing All Randomized Patients (ITT)
Quartiles of Time to Healing PCR+ Patients
Quartiles of Time to Healing All Randomized
Loss to Follow-Up PCR + Patients
Impact of Pre-Treatment Cold Medication Use (PCR+ Non-Users)
Impact of Pre-Treatment Cold Medication Use (PCR+ Users)
Impact of Smoking (PCR+ Non-Smokers)
Impact of Smoking (PCR+ Smokers)
Gender Analysis-PCR+ Trials 43 and 44
Smokers by Gender-PCR+ Trials 43 and 044
Time to Resolution of Individual Symptoms-Trial 43 (PCR+)
Time to Resolution of Individual Symptoms-Trial 43 (PCR+)
Time to Resolution of Individual Symptoms-Trial 44 (PCR+)
Time to Resolution of Individual Symptoms-Trial 44 (PCR+)
Secondary Endpoints PCR+ Patients
Efficacy Conclusions-1
Efficacy Conclusions-2
Efficacy Conclusions-3
Safety Review
General Adverse Events ɮ% in Pivotal Studies
Menstrual Disorders
Menstrual Disorders
CYP3A4 Induction
Potential Risk of Unintended Pregnancies
Potential Risk of Unintended Pregnancy
Tachycardia/Palpitations
Tachycardia/Palpitations
Summary of Application Issues
Summary of Application Issues
Summary of Application Issues
Summary of Application Issues
Pleconaril Review Team
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