FDA Denies Cytomedix Gel Marketing Claim Tuesday October 17, 9:49 am ET Cytomedix Receives FDA Denial Letter on Marketing Claim for Wound Treatment AutoloGel
ROCKVILLE, Md. (AP) -- Biotechnology company Cytomedix Inc. said Tuesday the Food and Drug Administration denied the company's marketing claim that its AutoloGel wound healing treatment is equivalent to similar treatments on the market.
ADVERTISEMENT click here In a statement, the company said the agency's primary grounds for rejecting the claim involve the use of bovine thrombin, a clotting agent derived from cows, to activate the plasma in AutoloGel.
Although bovine thrombin has been used on humans in surgery and other instances to stop bleeding, and is also used along with platelet gel therapy products that have been cleared by FDA for surgical use, complications can involve the creation of antibodies that could cause a bleeding tendency.
No such complications were found either in clinical trials or in medical reviews, the company said.
"The company will immediately pursue an appeal not in an adversarial approach with the agency, but in a consultative mode to assure that the company's position, including the views of additional scientific experts are fully considered by the FDA," Cytomedix said in a statement. The appeals process is expected to be complete in 60 to 90 days.
The company could not be immediately reached for comment early Tuesday morning.
Cytomedix said it met with the FDA in September, where a variety of safety and effectiveness issues were raised and the agency asked for more information. Cytomedix said it sent the requested information, and was notified Friday of the FDA's position.
"We are very disappointed with this decision. We continue to believe, based on the safety and effectiveness information that we have submitted, that our product merits marketing clearance by the FDA. We will work through the appeal process as expeditiously as possible," said K****ij Mohan, chairman and CEO.
Cytomedix will hold a conference call to discuss the matter at 4 p.m. Eastern time.
Shares closed Monday at $2.75 on the American Stock Exchange.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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Listen to the call, it sounds very promising I think the company will prove thier worth. They said that the FDA gave them all indications for the approval but it didn't happen.
-------------------- This is the start of something big Posts: 242 | From: Michigan | Registered: Apr 2006
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Did you guys see how it bounced from that crazy low?
Bottomed at 1.01 from 2.75.
I was able to get 5000 shares at 1.04 and exited at 1.37 near EOD. I'm gonna watch the charts and level 2 and if there's momentum and a good dip I'm gonna attempt another flip tomorrow.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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