Belviq, developed by Arena, the US biotech company, was authorised as safe and effective by the Food and Drug Administration last June, but has yet to be ratified by the DEA under a process designed to ensure controlled use of medicines that come with a risk of abuse.
The FDA recommended that Belviq, known generically as Lorcaserin, be classified as a “schedule IV” drug, a low-risk category, which gives regulators some supervisory powers to oversee prescriptions.
But an unusually high number of 69 comments have been filed on Belviq, creating a greater workload for DEA officials in making an assessment.
The stalling has allowed Qsymia, a weight-loss drug made by Vivus, a rival US biotech, to gain a lead over Belviq, even though the drug was approved after Belviq by the FDA. While most of the 47 positive remarks on the DEA website are identified by the name of the author, 19 of 22 negative ones are anonymous, sparking debate over whether individuals with a vested interest in delaying Belviq have been posting criticisms.
Let's organize a STOP the DEA Delay Day and have hundreds of ARNA shareholders calling DEA to request action. The delay is causing harm to the company, patients and shareholders, all citizens that deserve a fair and timely process. This delay is rediculous and unacceptable! Pick the day, share the names and numbers and let's get organized. All calls should be made in a respectful way as concerned citizens, to avoid problems for ARNA. IMO, what do others think?
This article is not protective of the DEA action as someone suggested. It is just the opposite. The DEA has made a bad mistake taking on such a visible stock. That said, someone mentioned the long delay with the satellite radio merger as being another example of someone being in someone's packet.
Yup Sirius XM merger, took way to long and almost bankrupted both companies. All the big media players did not want that merger to happen. Today the stock is doing well trading over 3 bucks a share off of the low of .05 a share.