Vivus Inc. (VVUS): Qnexa Part II
Let me start off by going through some important dates that investors must follow closely for Vivus’ Qnexa, I will list them in order by date. Additionally, I have had to expand this to a 4 part analysis due to Real Estate problems with my website.
The Next Step
The next step in the process after the FDA has set a panel date is for the FDA to put together what are called the “FDA Briefing Documents.” The briefing documents are a collection of all the NDA’s filing material and the FDA’s official review of the data. Inside these documents are guidance questions and ideas which the FDA puts together for the FDA’s Advisory Committee to sort out. This is done because the FDA is seeking guidance from the Advisory’s Panel of experts in the field so the FDA can make a final decision on approval (a sample of FDA questions can be found here). The FDA also includes inside the briefing documents their concerns about the drug and what safety issues have come up during their review.
When the FDA first releases the Briefing Documents (the Briefing Documents can be found here when released), the press will get a hold of them first. Now keep in mind the Press is hungry for a story with headlines, so any concerns that the FDA has (and remember the FDA always has concerns because it is their entire job to pick apart the data) the reporter will pick up on and publish the most negative headline they can think of to get readers. This is common practice for journalists, you have to keep in mind most of these journalists have no clue what they are talking about so be prepared for a bad headline. Reuters has one of the worst journalists when it comes to this.
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Any reason for the drop in the stock price today? Haven’t seen any news coming out….
Not much that I can see, the shares will be very volatile up until the panel hearing date.
Yes, Lazzard anaylst downgraded the stock to HOLD from Buy….
VVUS was downgraded at Lazard to a hold. That is most likely the reason for the move down, but it found support and held the 50 day moving average.
Louie, would you happen to have a link to that. That news didn’t come across any of the wires that I use for Vivus. Many thanks…
Geoff
July 15 is a Thursday, by the way. So we should be looking out 2 days earlier on Monday?
Ok, my mistake. I must have been looking at June or my calendar from last year on my desk. I would say most likely the FDA will release them on tuesday then, sometime in the morning. IHere is the link to the announcement. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm214795.htm
Lazard downgrades shares to “hold” from “buy”
http://www.reuters.com/article/idCNN159865520100615?rpc=44
Great article. Thanks for sharing. How would a non-voting AC typically report its findings? For example, could it say it is approvable but additional safety studies need to be conducted? I think ultimately Qnexa will be approved but I’m concerned that the FDA/AC may move the bar as a CYA type move.