Replies to post #6987 on Tenax Therapeutics Inc (TENX)

[skyticket1]

Novel product / unique mechanism

Levosimendan is a novel, first-in-class calcium sensitizer/K-ATP activator that provides:
oxygen sparing improvements in myocardial contractility
reductions in afterload
potential cardioprotective effects

Unmet medical need

Currently there are no drugs indicated for the prevention or the treatment of LCOS.
The FDA has granted fast track status for the “development of levosimendan to reduce morbidity and mortality in cardiac surgery patients at risk for developing low cardiac output syndrome.”
Low LVEF cardiac surgery patients represent a high risk population who experience a higher incidence of LCOS and worse outcomes.
Levosimendan has the potential to improve outcomes in these high risk patients.

FDA fast track status

The FDA has granted fast track status based on the drug’s potential to fill a serious unmet medical need, and has agreed to the Phase 3 trial protocol under a Special Protocol Assessment (SPA). FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in the U.S.

[blimps]

NO study overseas will be considered as acceptable by the FDA. Period.