Let's Take a Look at the European Medicines Agency and Peginesatide (Omontys)
I have tried to post this information twice before with links to support what I say, but Yahoo has blocked it. Without the links, here it is. If you wish to verify what I say is true, and it is, you must do your own DD at the European Medicines Agency (EMA) web page.
Many of the AFFY Longs on this board are bullish since peginesatide (Omontys) is on the EMA list of drugs that are scheduled for approval in May, 2013. What the long pumpers conveniently fail to mention is that Omontys has been on EMA the list for approval since March 2012. The EMA could have approved Omontys anytime within the last year and 2 months but did not. Since March 2012 of course, Omontys has been recalled due to patient deaths and other adverse patient reactions. Why are longs touting that the EMA is going to approve Omontys now?
Also, the only recent action with the EMA insofar as Omontys is concerned is the EMA decision to allow Takeda to conduct clinical trial of peginesatide on pediatric CKD patients under 18 years with results to be completed by in 14 years which is 2027. See EMA Decision EMEA-000646-PIP01-09-M01.
It never ceases to amaze me the lengths Wall Street will go to induce retail to hold a losing position so that its cronies will not be left holding the bag.
Wooow do you really know EMA approval process or do you need a link? DNDN Stipuleucel is in the review list. Do you have any idea when they filed an application? Now I understand why Raj didn't want to respond to your post because you seem to add little twist to the facts. If Takeda is running another trial it's perhaps to add to the indication of Omontys.