What’s next?Alterity plans to meet with the FDA to discuss the potential for fast-track approval. Stamler notes that the FDA has been willing to approve drugs on biomarker data only. Two years ago, the agency did so on this basis for Biogen’s drug Qalsody (toferson), for a genetic form of amyotrophic lateral sclerosis (ALS, a form of motor neurone disease).“If we get clear biomarker efficacy and any [clinical] benefit, we will have a very active discussion with the FDA to accelerate approval and skip the next stage [a phase III trial],” Stamler says.“It depends on the strength of the data. With an untreated disease, if you show robust efficacy the FDA will take it seriously”.
IMO: says we might not have to do a Phase 3.. So we can start selling our drug Vote all resolutions in the affirmative
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)