Replies to post #13860 on ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Silvr, the 5,246 participant 5-year men's trial led by AbbVie is scheduled to be completed this month.

A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (TRAVERSE)

The 700,000 participant retrospective study is scheduled to be completed in November of this year.

Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes

As you stated, I believe AbbVie will strategically time the publishing of results for both men and women. And yes, ANIP is well positioned from the female perspective. If the data is equally compelling as Bayer's release, I expect an influx of investors into testosterone related stocks just as you saw Covid related stocks benefit over the last couple of years.

Should make for an an entertaining year.

JMHO

[Just the facts maam]

Silvr, AbbVie will soon have a lot to announce with respect to the Traverse Testosterone study.

Traverse study objectives and design
TRAVERSE (clinicaltrials.gov NCT03518034) is a phase 4, randomized, double-blind, placebo-controlled, non-inferiority, parallel group, multicenter study of transdermal TRT in symptomatic men with hypogonadism who have pre-existing CV disease or increased risk for CV disease. The primary aim of the TRAVERSE study is to determine the safety of TRT with regard to MACE in middle-aged and older men with hypogonadism. The study will enroll approximately 6,000 participants and continue until 256 primary major adverse CV events have been positively adjudicated, with an anticipated study duration of up to 5 years. Because of its long duration and large sample size, the study also provides an opportunity to evaluate prostate safety and several efficacy outcomes, including clinical fractures; sexual activity, sexual desire, and erectile function; remission of late life PDD (dysthymia); progression from prediabetes to diabetes and remission of diabetes; and correction of anemia and incidence of anemia.

Effects of long-term testosterone treatment on cardiovascular outcomes in men with hypogonadism: Rationale and design of the TRAVERSE study

Libigel data should come out soon, as well. They do not list secondary outcomes, it will be interesting to see what additional data was collected.

[Just the facts maam]

Silvr, keeping on the impressive Diabetes data, I am looking forward to what come out of the news conference scheduled June 12 at the Endo conference this weekend in Atlanta.

Sunday, June 12

Diabetes (10 a.m. EDT): The Society will unveil its Clinical Practice Guideline on Management of Hyperglycemia in Hospitalized Patients in Non-Critical Care Settings. In addition, researchers will explore diabetes’ effect on metastatic breast cancer outcomes, regional variations in hospitalization for diabetes complications, and prediabetes as a risk factor for heart attacks.

Endo News Conference

The Libigel safety trial was on track to have 770 participant with Diabetes mellitus.