ency
I own it and I can understand why Dr. Given wouldn't want to let the competition know what his problem is. If they run into the same problem in a year why should he let them prepare for it now.
if he doesn't get the approval then he didn't lose anything by not telling
He was optimistic on the call that he wouldn't need to do other trials. but that may not mean anything
Most drugs do not make as much money in Europe as they do in the United States because reimbusement in Europe is not as good. A competitor has a drug, Tracleer, approved in Europe that has reimbusement similar to the US. Encysive will probably be launched in Europe shortly. The market cap is probably fair to undervalued just for the European business, so that should give downside protection even if the FDA doesn't approve it in the US
The reason I believe that it should be approved here is because according to all of the data out there including the fact that Encysive even did a study where they did a head to head of their drug vs Tracleer, Encysive's drug Thelin, was clearly safer and had better efficacy than Tracleer.
It would be logical on that basis to assume it should be approved but logic doesn't always work when dealing with the
FDA.