Still another example of the fastidiousness of the FDA:
Protalix BioTherapeutics downgraded to Buy at WBB Securities; tgt $10 (6.21) WBB Securities downgrades PLX to Buy from Strong Buy and sets target price at $10 noting the co issued a press release announcing that it had received a Complete Response Letter from the FDAregarding the New Drug Application for the company's lead product candidate, Taliglucerase alfa for the treatment of Gaucher disease. The main questions raised by the FDA regarding the NDA relate to clinical and chemistry, manufacturing and controls. They believe that PLX full approval is now set back anywhere between six to twelve months depending on whether a Class 1 or Class 2 review of the CMC data will be required.
The CEO of AEGR will most certainly miss his time-table for his company's drug launch, i.e. if it even ever gets off the ground. t