FDA RULING ON NVLX, "FDA Orphan Approval Status: Not FDA Approved for Orphan Indication"
SHORT ALL YOU CAN!!!!!!!!!!!!!!!!!!!
Sentiment: Strong Sell
Young bio nvlx rec'd FDA orphan drug status approval on friday....Google...benzinga nuvilex fda....seems pr has not yet been issued....good chance to read up in time for opening bell....good luck.
Merck's shareholders should question why they paid 9B$ for a company whose main drug goes generic in a year and another one that will stall soon after launch when eravacycline will capture the gram negative segment with its oral formulation. What insurer in his right mind will be willing to pay for an additional 4-5 days of hospital stay while they can send them home with a step down pill treatment.
Merck obviously need to question how this whole debacle happened.
Legrande cubist has other products in the pipeline some in phase II that will most likely be approved. What Merck bought was the novel approach to super bugs. In the next 10 years with rates of antibiotic resistence rising this willbe an increasingly beneficial market to be in. Also Mercks sales force is one of the best in the world and may be able to ramp earnings up for the next few years until patent expiration. Beyond that Merck can still appeal the ruling and it may keep protections during this court appeal with an injunction.