Encysive Pharmaceuticals Receives Approvable for Thelin: What Does it Mean?
As Encysive’s stock sits some 50% below Friday’s close, investors pushed CEO Bruce Given for more information related to the approvable letter for Thelin, received Friday. To quote Dr. Given: “FDA is a bit of a black box….It’s quite rare for [drugs not for HIV or cancer] to receive first-cycle approvals.”
Is he correct? [I’ll give you a hint: NO…he’s not]]. What are the real statistics for first-cycle approvals? What factors influence first-cycle approvables for drugs eventually approved by FDA. Which types of drugs are most likely to receive first-cycle approvables? What’s the average time of approval for drugs that receive and approvable? What are the most common issues delaying approval?
These and many other issues related to FDA approvable and related actions are described in detail in an upcoming report from Pharma Growth Strategies. Get on the mailing list to be notified when the report is released in April.
