Biotech Values

[DewDiligence]

FCSC—As far as my reasons why I feel they will recieve approval, the company had a SPA, Advisory Panel Meeting, CRL, & safety study designed by the FDA which FCSC was proactive with. Study met all safety endpoints. FDA approved them on efficacy but denied them with a close vote on safety during their first submission…

All that took place before Restylane, Juvederm, and Radiesse were firmly established in the US market as safe and effective treatments for nasolabial folds. FDA reviewers can change their opinion of the merits of an application when the competitive landscape has changed, as it has in this instance.