For several weeks, the FIP community has been waiting for an announcement from Mutian that the company had made good on its promise to have FDA approval for its line of GS pills (called Mutian X), as an OTC drug under the FDA’s GRASE program.
Can the use of GS-441524 fall under the umbrella of the Right to Try Act or GRASE? The answer is NO –in both cases. The reason is simple: To be covered under ANY FDA program, the manufacturer or sponsor MUST be established with the FDA.
Who owns the chemical we know as GS-441524? Who is allowed to use it in a commercial product, and sell it on the market? The straightforward answer: Gilead Sciences and The Regents of the University of California.