Biotech Values

[TaxiCaT]

Wow - solid argument: Here is mine -

I’ve already presented an argument for why laViv won’t garner commercial sales of any consequence.

I could care less about the commercial sales, i'm playing the bump on approval - although I don't agree with you here.



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 -

Also we have this individual on our side:

Jeanne Novak, Ph.D.
Acting Vice President, Clinical/Regulatory Operations

Dr. Novak is a Founder and Principal of CBR International, a scientifically-based biotech development company. She got her Ph.D. in Experimental Pathology (Cell Biology) from University of Utal Medical School, and served as a FDA Senior scientist, credentialed Inspector and expert advisor to FDA Center Directors. Dr. Novak also serves as Acting Senior Vice President to biotech companies and she is pivotal in several recent FDA approvals. Currently, she is serving as the Authorized U.S. Regulatory Representative for Fibrocell.

here is no medical need for another dermal filler to treat nasolabial folds

Why does this matter and who are you to decide that? FCSC just missed approval last time around -