THREE YEAR DEVELOPMENT PLAN

 

Our primary objective is to conduct appropriate laboratory and animal studies so that we can file an Investigational New Drug (IND) application with the FDA. We have a focused, lean plan to achieve this.

 
 
 
 
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MONTHS 1-12


CANDIDATE SELECTION

STAGE 1

SYNTHESIS

• Use patent-protected screening assay to identify high potential compounds

EFFICACY

STAGE 2

• Conduct initial trial in validated animal model
• Primary and back-up candidates (full composition of matter IP

 
 
 
 
 

THE ROAD MAP TO HUMAN CLINICAL TRIALS

 
 
 
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Months 13-36


PREPARE FOR IND

STAGE 1

STUDIES

• Effeciacy & dose selection
• Toxicology
• Mutagenesis & carcinogenesis

VEHICLE DEVELOPMENT

STAGE 2

• Absorption/dissolution studies
• CMO contract
• Franz cell penetration studies

PREPARE IND

STAGE 3

• Set criteria for human testing
• Meet with FDA

 
 
 

work with RECENSA

 

Recensa has a high-potential product, experienced team, lean three-year plan to IND and multiple potential areas for growth. If this interests you, let us know how you would like to be involved. 

 
 
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