$PLX PLX response to the FDA CRL?? They don't even know why they got it? The virtual inspection was done! That's not fair! They answered all the FDA questions on safety and efficacy..they believed with the virtual inspection all was good! On the CRL no mention of anything in efficacy or safety!! They don't even know why the fda mentioned a visit to Israel. .or why sanofi Fabrazyme upgrade to full approval was in PLX CRL. . The FDA decision really doesn't make any sense. .sorry That's what I have. .
1
4
4 Likes