ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Silvr, looks like Female testosterone could fit with the FDA trend for approving some drugs.

Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints

“Our findings underscore the complexity of regulatory decision-making, as exemplified by evidence of effectiveness despite a null primary end point finding,” James L. Johnston, MD, of the department of medicine at Brigham and Women’s Hospital in Boston, and colleagues wrote in their research letter.

The position statement justifies effectiveness. A post marketing study could be used to validate efficacy in real world use.