The FDA will provide a letter within 30 days outlining the reasons for the clinical hold and the information required to have the hold removed. The Company had previously guided the initiation of Phase 1 testing in the United States before the end of 2012. The Company now estimates that Phase 1 testing of BCX4161 will be delayed approximately three months.
What a debacle the BCRX-Presidio merger has become.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”