Don’t get why SP has been smashed? Almost all companies that submit a de novo application need additional information/tweaks to gain approval by the FDA. Almost nothing has changed with the fundamentals of the project, just requires a bit more patience now. Guarenteed money for those willing to wait, anything under 10c is cheap as chips!
Ann: Update on US FDA De Novo Classification Request, page-114
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #