Obviously Thomas Gryta of DOW JONES NEWSWIRES has a bias towards VVUS.
"Vivus Sees Pathway To 2011 Approval For Rejected Diet Drug
11:29 AM ET 10/29/10
By Thomas Gryta
NEW YORK (Dow Jones)--Despite the regulatory rejection of its weight-loss drug, Vivus Inc. (VVUS) is confident that it can meet requests from the Food and Drug Administration and get approval for its drug next year.
Late Thursday, the Mountain View, Calif., company said it received a so-called complete response letter for its drug Qnexa that requests additional information but states no need for more clinical trials at this time. The company believes that it has sufficient data to meet the agency's needs and will file a formal response in about six weeks.
The FDA request is "just a step in the process towards approval," Vivus Chief Executive Leland Wilson said on a conference call Friday. He said the FDA requests were "clear and specific" and the company will not meet with the agency before filing a response.
Vivus shares rallied on the news, trading up 26% to $7.72."
VS
"Arena Shares Drop As Diet Pill May Face Long Delay
By Thomas Gryta
NEW YORK (Dow Jones)--Arena Pharmaceuticals Inc. (ARNA) are down 2.5% as the company likely faces a long and challenging road for its weight-loss pill lorcaserin after a Food and Drug Administration rejection.
The San Diego drug maker said the FDA wants more information about cancer incidence in rat studies and requested more data on lorcaserin's effectiveness. The company may need to conduct more clinical trails to answer those requests, possibly delaying any approval for years, and raising questions about the ultimate future of the drug.
"We view the task of disproving potential negatives (cancer risk) while arguing for approval on the basis of 'marginal' efficacy to be a difficult challenge," Canaccord Adams analyst Adam Cutler said.
Arena's stock, recently at $1.59, lost almost half of its value after an FDA panel recommended against approve in September. With a significant delay for lorcaserin, trading in Arena shares may be volatile because more than 30% of its shares were sold short as of late September."
AND
OCTOBER 25, 2010, 2:26 P.M. ET
Arena Diet Drug Rejection Reflects High Bar To Treat Obesity
By Thomas Gryta
NEW YORK (Dow Jones)--The rejection of Arena Pharmaceuticals Inc. (ARNA) and Eisai Co.'s (ESALY, 4523.TO) weight-loss drug, lorcaserin, confirms the high regulatory bar for such therapies, something that may not bode well for others making the same effort.
...
The rejection is the first official feedback from the FDA on the latest crop of diet drugs. A panel of outside experts recommended against approval last month. ...........
Although the lorcaserin decision shows the FDA's seriousness, it doesn't have any direct correlation to the other two drugs because they work in a completely different manner. ..
Vivus's drug is widely expected to get a similar FDA response .., but many expect less onerous requirements for approval.
Lazard Capital Markets analyst William Tanner said he doesn't expect more pre-clinical or clinical data will be required for Qnexa, but he believes there will be questions about birth-defect risks for one of the drug's components. ..
It seems that Gryta is getting directives from above to give a better light on VVUS than on ARNA.
Well I wouldn't be so quick to blame the media. I've always left them neutral in my mind because most of them don't really know what's going on and they simply react. They see the stock has jumped and plummeted and they search their sources for possible explanations.
ReplyDeleteNow there are some bad ones that have a conflict of interest. But those are the ones that constantly write articles even though there's no news.