Rising Biosciences Inc (RBII)

[andysmith]

So a compounding application as applies to the FD&C section with the FDA? That doesn't make any sense since RBII stated they are seeking NDC code ("so doctors can write prescriptions" via audio) and the FDA doesn't approve compounds under section 503 of the Drug Quality & Security Act revision.

So which is it with TSW? Is it seeking FDA approval for an NDC for prescriptions or is it a "compounded" mixture for FD&C/CGMP guidelines as a cosmetic product? Because it can't be both. You are stating one thing but the company has stated something very different in their PRs.


Thank you in advance for clarification.