Thera (and their partners TaiMed who are responsible for drug development and manufacturing) announced the FDA decision to extend the PDUFA date from Jan. 3 to April 3.
On October 25, 2017, at the FDA’s request, TaiMed submitted additional documentation related to the manufacturing section of the BLA, and the FDA subsequently decided it constituted a major amendment that required an extension to the target action date, to provide time for a full review of the submission. The FDA did not request any additional information from TaiMed in this notice.
The stock is down 17% on high volume as I type. It’s not the dreaded CRL, but it raises doubts and increases the investment risk.
On the bright side 2 of the analysts that cover the company, CIBC and Canaccord, are maintaining their prices targets. CIBC said “While this does come as somewhat of a surprise, we remain optimistic that Ibalizumab will be approved by the FDA, and that there is a real unmet medical need for the drug.”
For now I’m holding my shares rather than taking a profit, but I’ll be monitoring closely.
A poster on another bulletin board put it well: So, this stinks. To have Lucy pull the football out just before Linus kicks it (for you oldsters who are familiar with the Peanuts comic strip) is very irritating.