Mar. 11 at 8:23 PM
$WVE And personally, I have seen the FDA; DDMAC (in "olden" days) and OPDP, 'today' take particular, inconsistent or less than straight forward paths with biotech dev. companies. So, glad the message is clear: The FDA better evolve to protect the public, etc.; yet, fully realize the massive global risk for not being, fully, scientifically calibrated in approval process of paradigm shifting medical advance. It would be unacceptable, unsupportable and a disaster in various forms to the U.S.A. if they don't immediately, rapidly, yet prudently evolve.
Thanks to B_B and a few others that highlighted changes from leadership (V. Prasad's exit) to restarts or reviews in the biologics/genetic platforms.