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Allos Therapeutics, Inc. today announced the Company will hold a webcast conference call on Wednesday, September 2, 2009 to discuss the outcome of the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee meeting for FOLOTYN (pralatrexate).[/QUOTE]
Allos gets positive panel ruling, but shares slip
Allos Therapeutics stock falls despite FDA panel recommendation for Folotyn approval
By Marley Seaman, AP Health Writer
On Thursday September 3, 2009, 1:37 pm EDT
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Companies:Allos Therapeutics, Inc.
NEW YORK (AP) -- Shares of Allos Therapeutics Inc. retreated Thursday, as an analyst said a Food and Drug Administration panel vote on an Allos drug was "much more contentious ... than A group of FDA advisers said the agency should approve Allos's drug Folotyn, which is intended to treat T-cell lymphoma. But JMP Securities analyst Charles Duncan, who attended the meeting, said panelists ended up discussing unexpected issues about the design of the trial, which may have caused some investors to believe the FDA will not approve Folotyn.
The stock lost 50 cents, or 6.4 percent, to $7.36 in afternoon trading. Trading of Allos shares was halted all day Wednesday.
Duncan said the experts argued about the types of patients included in a late stage study of Folotyn, as well as the design of the trial and the nature of the data Allos submitted.
"There was a very hotly contested debate on all of those issues," he said. However, the panel recommended the drug be approved in a 10 to 4 vote. In a note to clients, Duncan said that vote "clears the path for approval of the drug."
Duncan said the panel members were arguing about the different sway clinical trials can be conducted, and most were not opposed to approving Folotyn. The FDA is scheduled to make a ruling on Folotyn by Sept. 24, and while it is not required to follow the advice of its panels, it often does so.