RE: Massive bounce due14 Feb 2019 10:02
Guys read rns, do not understand this hugely inflated drop. They have not said they’re not going to approve, they have actually gone as far to say “before NDA MAY BE APPROVED”. Don’t see any problems here..
..’The CRL states that the FDA cannot approve the NDA in its present form and indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved. Motif Bio plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies.’