RE:RE:RE:Biogen update Seemed like a formality at this point. The FDA can't take any more stink right now so killing Medicare will just have to wait for war profiteering to take the spotlight off pharma profiteering. But the decision said nothing about the medical strategy, the door remains wide open for Promis.
“Monoclonal antibodies directed against amyloid that are approved by FDA for the treatment of AD [Alzheimer’s disease] based upon evidence of efficacy from a change in a surrogate endpoint (e.g., amyloid reduction) considered as reasonably likely to predict clinical benefit may be covered in a randomized controlled trial conducted under an investigational new drug (IND) application,” CMS said in its final decision summary.