Quote:
Originally Posted by Natalie8
RW, correct me if I'm wrong. Doesn't Biogen/Elan have to report all PML cases to the SEC? Or do they get to decide what to report? Also, they are required to report to the FDA, correct? But that FDA info isn't necessarily public, right? I think Wiz said the FDA person she spoke to told her to use the Freedom of Information Act. How obnoxious.
|
Nope. They don't have to report to the SEC. It's not considered to be a material event that affects financial operations until the FDA says that the risk rate is outside of the label statement.
They have to report CONFIRMED cases of PML to the FDA from the USA. They MAY report confirmed cases from other countries to the FDA. Anyone can file an AERS report to the AERS database, even people like us, but it may or may not get investigated. The FDA usually does an update on their Medwatch page when something happens in the USA, not in the rest of the world, and since the USA rate is still within the 1:1000 label, I don't see anything coming soon, but I monitor the page anyway.