here is the latest from AG Edwards:
1-15-99: Rezulin scheduled for panel review, weakness is buying opportunity.
Today's news, while negative in the short term, could be positive in the long term for both Rezulin and WLA in the drug is vindicated by the FDA's panel review. We believe that vindication will emerge from the review based on what we see as a clearly positive risk/benefit profile. the FDA's endocrinologic and metabolic drugs advisory committee is scheduled wla's rezulin oral therapy for type 2 diabetes in a regularly scheduled march 26 meeting. unless this review illuminates new data to indicate higher rates of liver problems or death than the rates we know of now, we do not believe it poses significant risk to rezulin or wla. In the original marketing application for rezulin, the company reported a 2% rate of elevated liver enzymes. in post marketing surveillance the company has reported a rate of serious liver injury that initially was 1 in 44,000 (0.002%) and has now declined to 1 in 100,000 (0.001%). Out of the estimated 1.4 million patients who have taken rezulin there are 33 reports (0.002%) of drug linked deaths. We do not find any of these rates of adverse events troubling. We would note that all drugs carry risks and that glucophage, another popular diabetes drug, is associated with a 1 in 33,000 incidence rate of latic acidosis which is fatal 50% of the time, and that insulin itself can and does cause serious hypoglycemic events in patients every year.
specifically, the committee will review the post marketing safety and efficacy data (also available on the company website) and it will review the supplemental NDA for use on rezulin in combination with other diabetes drugs (glucophage and sulfonylureas) The company's response to the news has been to welcome a "rational review" of rezulin in a scientific forum. given the recent negative LA Times article and others like it we understand and agree with the sentiment. The FDA is often criticized for being too slow and too fast, sometimes in the same article. In other words, sometimes the FDA needs to react to "political" pressures or headline journalism. bottom line, we think today's pressure on the shares represents a buying opportunity.
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I will post the latest opinion regarding earnings soon.
Greg J. |
