Completed Milestones & Achievements
July 2018 – Dec 2022
Safety and efficacy literature searches
July 2018 – April 2019
Initial Artificial Intelligence Based Proof Of Concept Study
June 2019 - April 2020
Formulation and Development
April 2020
In Vitro Laboratory Proof of Concept
June 2020
Initial FDA Contact
September 2022
Animal Efficacy Study
August 2024
US Patent awarded for enhanced skin permeation of active drug Alprostadil
2018 – ongoing Interviews and conversations with target users and their partners confirms enormous market demand
Customer/Market Validation
Go-To-Market Strategy
01
Proof of Concept
Initial Product Development, Proof of Concept and Animal Efficacy Study completed.
COMPLETED (2018-2022)
02
Patent Approved
Patent awarded in August 2024, for discovery related to enhanced skin permeation of the active drug, Alprostadil. Additional claims will be filed.
(US PATENT AWARDED 2024)
03
Complete FDA Filing
Finalize product formulation, and related Chemistry, Manufacturing and Control (CMC), and Clinical Bridging. Complete Initial Drug Application (IND)
(ESTIMATED 14 MONTHS)
04
Clinical Studies For Human Safety And Efficacy
The safety and efficacy of the ingredients is well established for decades. The active ingredient is US FDA approved for injection.
(AFTER FDA FILING)
05
Create Awareness Among Urologists
Work with Key Opinion Leaders to conduct human efficacy studies and CME presentations to Urologists to create awareness.
06
FDA Approval
Obtain US FDA approval under the 505(b)(2) accelerated application process for novel topical delivery of existing injected drug product
(ESTIMATED 24-36 MONTHS)
07
Global Market Penetration
Build doctor and patient awareness, drive demand and sell into Urology and Primary Care Physician channels.
Funding Requirements
$6 MILLION
Months 1 - 14
File With FDA
FDA Filing submission preparation
$6 MILLION
Months 15 - 24
Clinical Studies
36 person toxicity and 120 person efficacy studies
$6 MILLION
Months 15 - 36
Post Clinical
Operational, Marketing and post-filing costs
$18 MILLION
Months 1 - 36
TOTAL FUNDING TO FDA APPROVAL
Disclaimer
This website presentation and the information contained herein is for informational and discussion purposes only and is not, and may not be relied on in any manner as, legal, tax or investment advice, any recommendation or opinion regarding the appropriateness or suitability of any investment or strategy, or as an offer to sell or a solicitation of an offer to buy an interest in Madera Pharmaceuticals INC
