Hemosol (886290) erhält FDA-Zulassung! Tradingchance - 500 Beiträge pro Seite

[Ichtradegern]

TORONTO -(Dow Jones)- Hemosol Inc. has received clearance from the U.S. Food and Drug Administration to begin a Phase II clinical trial, HLK 210, to assess the efficacy and safety of HEMOLINK in patients undergoing orthopedic surgery.
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In a press release, the company said it expects that this study and HLK 213, an ongoing study in primary coronary artery bypass grafting (CABG) surgery, will form the basis for the initiation of its Phase III program, pivotal for approval to market HEMOLINK in the U.S. The completion of an additional CABG trial, HLK 214, won`t be necessary in order to proceed to Phase III.

"Based on this recent guidance from the FDA, we now have a significant amount of clarity regarding the direction of our program in the U.S. This allows us to proceed toward our objective of starting our Phase III program in 2003," the company said. "We have begun site initiation for HLK 210 and are conducting this trial on a high priority basis."

The HLK 210 trial will be a randomised, single-blind, controlled 80-patient clinical trial to assess the efficacy and safety of HEMOLINK in patients undergoing high-blood-loss orthopedic surgeries. The primary objective of the study is to determine the efficacy of HEMOLINK in avoiding the transfusion of banked blood within 28 days of a patient`s surgery and will have a maximum dose of 300 grams of HEMOLINK.

Hemosol is a biopharmaceutical company.

Company Web Site: http://www.hemosol.com

-John Moritsugu, Dow Jones Newswires; 416-306-2100

[mutz1]

das ding geht ab wie schmitz katze..

[Ichtradegern]

In Berlin schon 1,45 Geld.
Glückwunsch allen die dabei sind.

Gruß

[Ichtradegern]

1,59 $.
Nicht schlecht...

[mutz1]

hemosol scheint an einer großen sache dranzusein!

[spitzohr]

Abwarten und Tee trinken, beruhigt die Nerven.
Hemosol war schon mal bei 25.-- also noch viel Luft dazwischen.Nach unten kann`s auch ganz schnell gehen.

Spitzohr