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@Isa: Was den Kurs aber hemmen wird sind die ganzen offenstehenden Call-Optionen auf CVTX. Ich werde mir mal den Conference Call anhören, aber erwartet nichts Erhellendes! Die werden sich schön brav bedeckt halten, bevor sie sich wieder mit der FDA-Bürokraten treffen werden. Alles andere wäre Selbstmord. Und wie so oft gibt Dow Jones den spätesten aber auch den qualitativ besten Bericht. _______________________________ Dow Jones Business News Panel Suggests Additional TestsPanel Suggests Additional Tests for CV Therapeutics Heart Drug Tuesday December 9, 6:46 pm ET By Roger Cheng NEW YORK -- A Food and Drug Administration advisory committee adjourned Tuesday without making any recommendations on CV Therapeutics Inc. (NasdaqNM:CVTX - News)`s angina drug Ranexa, but has indicated more tests are needed. The FDA`s cardiovascular and renal drug advisory committee asked CV Therapeutics to clarify and expand its trials. After the meeting, panel Chairman Jeffrey Borer said in a Bloomberg report "a population resistant to available drugs wasn`t studied. So it is hard to know if the drug would add benefit relative to risk." The meeting came a day after the fate of Ranexa was thrown into question when the FDA outlined its concerns on its Web site Monday. The news sent the stock down 27% Monday. The stock was up one cent to $12.22 Tuesday. "Consideration of the potential benefit ... vs. risk ... leads the reviewer to ask for additional data prior to any approval," the FDA`s documents said. According to the documents, the agency is asking for the company to perform " an appropriately sized outcomes trial showing an improved survival" comparing to a placebo. The agency said the company could run that study on patients who have failed other angina drugs. CV Therapeutics also needs to clarify appropriate dosing, the agency said. The FDA is also asking the company to evaluate how well the drug works in women. "The sponsor could, potentially, incorporate some type of gender evaluation in a study of refractory patients," the documents said. A spokesman for the FDA wasn`t immediately available for comment. A CV Therapeutics spokeswoman confirmed the panel adjourned without making a decision, but didn`t elaborate on the what was said. In his downgrade of CV Therapeutics` stock Monday, CIBC World Markets Corp. analyst Matt Geller wrote that "when and if the drug will be approved is now uncertain." The FDA has concerns about side effects, most notably the increase the so- called QTc interval, or the time between heart beats that occurred during the clinical trial. There were incidences of a three- to nine-millisecond increase in the QTc interval compared with a placebo in both of the company`s large clinical trials. If the time between heart beats is extended too long, the result could be sudden cardiac death. The agency is also concerned about drug interactions. "The FDA is not convinced that the company has demonstrated that the QTc prolongation will not lead to arrhythmias," Mr. Geller wrote in his note. The analyst doesn`t own shares in CV Therapeutics, but CIBC has an investment- banking relationship, and has managed or co-managed a public offering the last 12 months. |
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| aus der Diskussion: | +++ CV Therapeutics Inc (CVTX) - Kurssturz +++ |
| Autor (Datum des Eintrages): | puhvogel (10.12.03 10:10:41) |
| Beitrag: | 69 von 470 (ID:11564560) |
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