Until recently, it appears the FDA anticipation fat bodies care to aloof stop bistro so abundant or jump on the treadmill added often. What added acumen could there be for the bureau throwing so abounding roadblocks in the way of -to-be blubber treatments? Of course, the FDA claims accessible bloom concerns, but let’s face it: Every biologic has ancillary effects. However, abounding in the industry advance the focus should be on accident against benefit.
Maybe with the abridgement in the doldrums, the FDA is acceptable added realistic. That ability be acceptable account for the companies allusive to get new blubber treatments on the bazaar and for their investors.
One of the beneficiaries of the FDA’s attitude acclimation could be Mountain View, Calif.-based Vivus (NASDAQ:VVUS) and Qnexa, the company’s biologic applicant actuality developed to abode weight loss, blazon 2 diabetes and adverse beddy-bye apnea.
Last fall, Qnexa looked like it had about as acceptable a adventitious of hitting the bazaar as the Tampa Bay Rays did of acceptable the agrarian agenda in the American League East this season. But afterwards actuality alone by the FDA over abhorrence that the biologic would access the accident of cardiovascular problems, Qnexa looks to be on the improvement trail.
Recently, Vivus said it had accomplished acceding with the bureau on a plan that allows for an aboriginal resubmission of the Qnexa New Biologic Appliance for the analysis of obesity. The resubmission plan allows Vivus to seek approval for an antecedent adumbration that includes adipose men and women of non-child-bearing potential.
Based on this agreement, Vivus intends to resubmit its Qnexa appliance by the end of October. And in the aboriginal division of 2012, the FDA will conduct an Advisory Committee affair for the drug. VVUS shares jumped added than 9% in the canicule afterward the advertisement but accept aback acclimatized aback to area they traded afore the news, $8.18.
Maybe investors abhorrence the FDA will backslide to its old means or are anxious that approval of the biologic still is a continued way off. In the interim, Vivus ability accept to accession added banknote to accumulate its doors open. And alike if Qnexa eventually gets approved, it’s acceptable to accept some antagonism accustomed the FDA’s “easing.”
Last week, Orexigen (NASDAQ:OREX) adored its diet us Contrave aloof three months afterwards it looked asleep in the baptize afterward the FDA’s appeal for an all-encompassing analytic balloon to abode the affair of abeyant cardiovascular problems. Now the aggregation has the ambitious from the bureau to conduct a abate and far beneath big-ticket biologic balloon that would be completed and advised by 2014.
Perhaps the FDA’s accomplishments on Qnexa and Contrave accept renewed achievement at Arena Pharmaceuticals (NASDAQ:ARNA), whose diet us locaserin was nixed by the FDA about a year ago. The aggregation continues to abstraction the drug.
It’s accessible the FDA is demography a attending at the big account about to blubber treatments. Maybe they got the bulletin actuality consort at aftermost week’s sixth anniversary Blubber and Wellness Congress in Washington, D.C. There, Kenneth Thorpe, a Vivus adviser and assistant at Emory Rollins School of Accessible Health, said that a 10% weight accident in patients ages 60 to 64 ability be able to accommodate Medicare accumulation of $8 billion over 10 years and $35 billion over their lifetime.
As of this writing, Barry Cohen did not own a position in any of the above stocks.
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