Replies to post #3527 on PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[king oil]

Update: apparently the CRL is due to the FDA being unable to inspect the facility in Carmiel Israel. The third party facility was approved via Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act in lieu of a pre-licensing inspection.

So if I understand this correctly, the FDA delayed the decision for 3 months because they were unable to travel to Israel to inspect the facility. Then 3 months later they still didn't bother to travel to the facility and rejected the application because they were unable to do the inspection. On what planet does this make any sense?

There is also reference to Fabrazyme being converted to full approval so any new submission by PLX must be in the context of that change. I'm guessing that this means a more demanding requirement for PLX to show superiority vs. Fabrazyme?