OXBT will rise very soon. I researched on the historical facts on FDA approvals for Fast Track Applicants. In 13 years, theres been only 248 applicants. Also those who are granted this Fast Track have priority reviews because of its neediness. Also, I think the FDA approval will be coming soon because PHASE III trials usually requires two successful trials; however, the SPA only requires them to only make one successful design to receive an okay. Lets get our info straight before posting worthless statements.
Oh, it will be approved. I don't doubt that. I just think you guys are being impatient and are fantasizing about an unrealistic timeframe. FDA will give the green light to market levosimendan in the United States around Q3 of 2014. Look; the phase III trial is scheduled to start around Feb. 2014. It takes 60 days, which takes us to April 2014. Then, the FDA has to approve the trial, and they are s l o w ! So I say Q3 of 2014.
Also, we should be aware that this drug is backed by Orion, who is also associated with Phyxius. We all know that this drug is getting an approval, it's just the matter of when the surprising opening of OXBT will be.