...salient points...I have only been in for about 10 months for the same story...I suppose I cling to the notion that some westernization may still take place in pharma-retail over there, specifically with prescription medication, which could be a catalyst...
Agenus Inc And GlaxoSmithKline's MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Melanoma Misses First Co-Primary Endpoint
Agenus Inc announced that GlaxoSmithKline`s DERMAi study, a Phase 3 randomized,
blinded, placebo-controlled MAGE-A3 cancer immunotherapeuticii (CI) trial, which
contains Agenus`QS-21 Stimulon adjuvantiii, a component of GSK`s novel adjuvant
system AS15, did not meet its first co-primary endpoint. In an independent
analysis, the study did not significantly extend the disease-free survival
(DFS)iv period when compared to placebo in the overall MAGE-A3 positive trial
population. In line with the Independent Data Monitoring Committee`s (IDMC)
unanimous recommendation, GSK will continue the study until the second
co-primary endpoint is assessed. This co-primary endpoint is based on predefined
criterion that was agreed upon by regulatory authorities. This analysis, which
is based on gene signature, is designed to prospectively identify patients who
may have the capability to be more immunologically responsive and therefore can
potentially benefit from treatment. If further analysis shows that the
predefined gene signature subset data are successful, there is the potential
that a regulatory filing could be considered. GSK anticipates that these data
will be available in 2015. Until then, GSK will remain blinded to all safety and
efficacy data. The IDMC for the DERMA study indicated that the current review of
the safety information raised no concern for the continuation of the trial.
Geez: Let them come out with their upcoming interim data first---then we can parse whether they get to submit, whether there will be a REMS with any approval, or whether there will be an advisory meeting to hash it all out? Or even if the data suggests carrying on the study without submitting at this point---that is possible. The FDA will decide this in the end via conversations with OREX! As SP says its all a guess at this point!
The markets know attaching to VVUS was a mistake, they still aren;t buyng totally into Belviq off their perceived LOE (not much true), so OREX is Mr markets latest hero to attach to like a bloodsucker! They may be repeating their VVUS mistake on the next combi coming down the pike?
I wait until data comes out! Then maybe the markets will go whoa if said data isn;t compelling! I will continue to have cardio concerns about this combi plus other AE issues until they PROVE its unwarrented. I see little way this drug could even be on the market selling until 2015 myself off the likely process it needs to go thru.
Lets wait and see!
Sentiment: Strong Buy
You should consider owning both stocks! Bio-Diversification is good!
Sentiment: Strong Buy
Fannie Mae Preparing For First Transaction Where Bond Investors Share Mortgage Default Risk
Anthony B. Sanders – George Mason University
September 4, 2013
Please Google to find the article. Fannie Mae is planning to survive, no matter which changes the government may throw at them.