Dale...
The following is the more complete report from the analyst at CEUT.
I have highlighted some of what I think are some of the more outlandish statements.
Bob T.
Vivus, Inc.
Jan , 18 , 2002 , 08:00 : Despite its relatively small size and short corporate history (ten years), Vivus already has proven its ability to rapidly develop a drug for a sexual condition that historically has been misunderstood, under-diagnosed and for which there are no currently approved products. Vivus accomplished this first in the mid 1990s with the rapid development and approval of MUSE.
With the FDA’s approval yesterday of the IND for TA-1790, Vivus now can begin U.S. clinical studies of TA-1790, an orally administered PDE-5 inhibitor to treat erectile dysfunction (ED). As a result, Vivus is on track to have two of its lead compounds in pivotal studies by year-end.
Vivus plans to initiate the first pivotal study (Phase II/III) of ALISTA, topically applied alprostadil to treat female sexual arousal disorder (FSAD), in 1Q02. If successful, Vivus could enter a confirmatory Phase III trial in 1Q03 with a possible NDA filing in 1H04 and possible FDA approval in late 2004/early 2005.
My comment. Ye gods a possible FDA approval in late 2004 or early 2005. Surely that merits a big LONG investment now!!!
For TA-1790, Vivus will first conduct a Phase II dose-ranging study to test erectile response using a Rigiscan. Other ancillary tests (blood pressure response to and nitrate interaction with TA- 1790) also are expected to establish safety parameters, which may differentiate TA-1790 from other PDE-5 inhibitors. By year-end, Vivus plans to begin enrollment of its first pivotal (Phase II/III) study of TA-1790.
My comment. With Phase one just starting vs where they are with ALISTA it could be 2005 at least before this is marketed if ever! Again, another reason to invest now...NOT!
As Vivus advances the development of two compounds into initial pivotal studies, the prospective value of its portfolio to possible marketing partners should increase substantially. Despite the rise in Vivus’ share price over the last month, we believe that its market cap continues to pale in comparison to the potential value of its portfolio. Accordingly, we are raising our 12-month target price to $14 from $7. With a calendar full of potential catalysts throughout 2002, Vivus remains this analyst’s top pick for the year.
I wonder if this analyst was recommending Enron??? |
