Brazil label came out and there are idiots causing speculation that are clearly short. Don't fall for the trap, I added here. Run ups normally start after bad news. It ran from 4 last bad news (financing). Only see up potential from here price target of 8 at least.
They had all their manufacturing, procedures and practices Inspected and approved before submitting their NDA this time. Their drug is currently being used by the FDA and Europe to treat patients with serious cases. This proves the drugs safety and efficiency is acceptable by FDA standards.
The only issue was manufacturing etc. Do some DD you'll find it was resolved and approved by FDA.
TOO MUCH Misinformation. There was reported 6% 1gC antibodies compared with 15% for Cerezyme, and 10% for Vpriv. The 6% Hypersensitivity is comparable to the labeled' 6.8% for Cerezyme. There is no safety issues.