TCDA Receives Complete Response Letter

TCDA received a Complete Response Letter on 8/22 from the FDA on its chronic kidney disease treatment drug veverimer. Although the company previously stated the FDA concern was a “marketing issue”, the CDL was focused on concerns about the magnitude and durability of veverimer effects and wants to see the results over a longer testing period. The CRL does not quite fit with TCDA’s claim that this was a marketing issue. I’m disappointed and out.…