Biotech Values

[DewDiligence]

The document you cited was penned by FCSC itself, not by the FDA.

The Committee voted 11 to 3 in favor of the drug's efficacy and 6 to 8 against its safety for the proposed indication of treatment of nasolabial folds/wrinkles on the first go round. There don't appear to be any significant safety issues.

Huh? If there are no significant safety concerns, why did the advisory committee vote that safety was not established?

A biologically active cell-based therapy is always going to have lingering safety concerns when used for a cosmetic indication like nasolabial folds. There is no compelling medical justification to risk such a treatment when effective and very safe biologically inert fillers such as Restylane, Juvederm, and Radiesse are available as alternatives. That’s why I’m certain that laViv will be a commercial bust for nasolabial folds even if it manages to get FDA approval.