Anavex Life Sciences Corp (AVXL)

[powerwalker]

Leqembi was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The results of a Phase 3 randomized, controlled clinical trial to confirm the drug's clinical benefit have recently been reported and the agency anticipates receiving the data soon.

So, the fda gave the drug AA with NO DATA in its files!!!

Does that make sense? If so, please explain.