RespireRx Pharmaceuticals Inc (RSPI)

[jor8888]

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For FDA approval and commercialization, a Phase 3 trial of dronabinol in OSA will be required. The clinical trial protocol will be written in conjunction with the clinical advisory panel and a licensing partner, however, some estimates of cost and time can be projected for budgeting and planning purposes. To that end, RespireRx estimates that the Phase 3 trial will require less than 300 patients at ~15 sites, and take approximately 24 months to complete, at a cost of roughly $12 - 14 million.

 

Revenue Forecast

 

The market potential for a new drug treatment for OSA is enormous, with a target market of nearly 20 million people in the U.S. alone. The original patent for the use of dronabinol for OSA is valid through 2025, so a Branded Generic Dronabinol at 80% of the price of current generic dronabinol products, and with only a maximum 10% market share, still achieves annual revenues exceeding $11 billion, as illustrated in Table 6."
https://www.sec.gov/Archives/edgar/data/849636/000149315217007695/ex99-4.htm