Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Pseudo Biologist who wrote (11372)	8/18/1999 1:15:00 PM
From: Slugger	Read Replies (3) \| Respond to of 17367

Great article PB. Here are the main quotes from the article: "The market was clearly reacting to the fact that we had no news as yet, and that was disappointing," said Peter Davis, Xoma's chief financial officer. "We have no news right now and we didn't want to put out anything that the FDA might consider as pressure. We wanted to convey that in a preliminary view, the results seem positive - that we saw an overall clinical benefit - and that we're working toward filing a BLA. People may have been expecting something more definite but that's all we can say. We don't want to speculate." --- Richard Stover, senior analyst with Arnhold and S. Bleichroeder Inc. in New York, said the company's cautionary tone was warranted. "Even if it's knock-your-socks-off data, the FDA should see it before the public," he said. "There's been lots of confusion and people are drawing inferences where there are none to be drawn. There has been some gross misrepresentation of what the company said about the drug. We learned one new thing about the drug - that is wasn't a bust. That means it could be marginal or very good and we'll just have to wait." --- "We started with the endpoint being mortality," Davis said. "But it made more sense to do a composite endpoint - mortality as well as morbidities, such as amputations and organ damage. It's a very complex analysis." The complexity of the disease and its quick onset makes compiling statistics difficult, Stover said. "We cannot emphasize enough that this is the first - and perhaps the only trial of this magnitude - that will be completed in this population. A detailed analysis is absolutely essential to the final assessment. A question on one or two patients could change the data." --- Davis would not comment on the next steps for Xoma in this indication. Stover said he expects Xoma to discuss trial data and regulatory issues with the FDA in October. Next month Xoma will release interim data from 800 patients in the Phase III trial of Neuprex for hemorrhagic trauma. Enrollment of all 1,600 patients should be completed this year. The primary endpoint is the prevention of pulmonary complications that occur in 30 percent of all hemorrhagic trauma patients. "That's a bigger story and we'll also get a truer picture of what the drug can do," Melnitchenko said. "The efficacy is easier to prove and the patient population is larger. We'll know next month if it's working." bioworld.com