(If you doubt anything i am writing then please google key words like SIMDAX FDA and ABBOTT SIMDAX before calling me names ).So first the hype this stock received about 600 million potential drug levosimendan is nothing new but same drug SIMDAX which was developed by Finnish company ORION which applied for FDA approval in 1999 and was rejected ,then it partnered with ABOTT labrotaried and tried failed again in 2006 .Now they gave it phyxius pharma ,since phyxius is broke private company they partnered with OXBT .
[The calcium sensitizer levosimendan gives superior results to dobutamine in postoperative low cardiac output syndrome].
[Article in Spanish]
Levin RL, Degrange MA, Porcile R, Salvagio F, Blanco N, Botbol AL, Tanus E, del Mazo CD.
In this randomized study, levosimendan proved more effective than dobutamine. Postoperative morbidity and mortality were lower, fewer patients required either an additional inotropic drug, a vasopressor or intra-aortic balloon counterpulsation, and the length of stay in intensive care was shorter.
[Levosimendan and low cardiac output syndrome. Does mortality really decrease? ]. [Rev Esp Cardiol. 2008]
[Superiority of levosimendan to dobutamine in postoperative low cardiac output syndrome: is it due to previous beta-blocker treatment?]. [Rev Esp Cardiol. 2008]
PMID: 18462650 [PubMed - indexed for MEDLINE] Free full text
Sentiment: Strong Buy
It failed in Abbott's trials YET has been good enough to be sold in Europe, which means Abbott simply gave up to early or didn't think it was worth it. From what I read, it worked in Abbott's study, but it was not massively superior to placebo. But it did work. It did not fail. It just didn't blow placebo away. If I am correct, Abbott was a multi billion dollar company at the time and didn't need an iffy small revenue gainer. So, they sold it back to Orion, who tried to get it approvd in the US using old data from European trails. The FDA said "no; you need new data for us." Orion said "nevermind. Why bother? we'll just do Europe."
It was never rejected by the FDA. That's misinformation. The FDA would not look at old data. No new trials were run. That means there was no drug application submitted. IT was not rejected because it was reviewed.
It has been approved in Europe.
You are right.Same drug for which orion was a deveolper did not bother to go ahead with additional trails and sold it billion dollar company abbott which also said nevermind .I will never believe it will show any magic this time when given to broke small company like OXBT