There are plenty of reasons to delay approval until a big safety study emerges.
That will limit sales, and, since Arena has not submitted such a plan, delay approval.
Nor will they any longer be able to delay approval of his judicial nominees.
Kate Winkler, an analyst at Merriman Curhan Ford who rates Genta a neutral, thinks the FDA will delay approval.
And the downside to the stock if the FDA does delay approval by asking Dendreon for more data is probably much bigger than any potential gain.
Hammering out a REMS tends to delay FDA approval, and having a REMS can hurt sales.
None of this will happen quickly, however, if only because antitrust concerns will delay any approval of the deal until at least early next year.
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It also announced a delay in seeking approval for its osteoporosis drug.
An illustration earlier this year was the delay in FDA approval of a biological used to treat Pompe disease--a debilitating inherited disorder--that was to be manufactured in a new, larger-scale manufacturing facility.
Pfizer has failed to disclose an apparent delay in the approval of a promising new antibiotic, a move that may signal a change in how much the company tells investors about the regulatory status of medicines as they are reviewed by the U.S. Food and Drug Administration.
Mooney estimates that doing new clinical trials could delay Erbitux's approval by as much as two and a half years.
Washington (CNN) -- A compromise proposal to expand background checks on gun sales lacks enough support to win Senate approval now, which will likely delay a vote on the measure that has strong public support, one of the sponsors told CNN on Monday.
His candidacy had been promoted by the German government and - after a delay - had won reluctant approval from the European Union.
The resignation of another cabinet member, James Tien, on July 6th forced Mr Tung to delay its submission for final approval by the legislature.
That deal, which a week ago appeared on the brink of gaining regulatory approval, already appeared headed toward further delay, 13 months after it was proposed, thanks to the swelling scandal.
Novartis could be facing a further delay on the U.S. approval of its diabetes drug Galvus, one of its most important experimental medicines, an analyst says, potentially giving an even bigger head start to rival Merck .
On Sept. 22, The Pink Sheet, a medical trade publication, reported the FDA had said that Pfizer received an "approvable letter" from the FDA. Such letters are not approvals but instead a kind of delay, saying that most of the data needed for approval are in but that additional steps need to be taken if the drug is to reach the market.
Aventis, the only big drug firm claiming to have a new class of antibiotic that's likely to win approval soon, is still held up after a two-year regulatory delay.
Hailed several years ago as a breakthrough immunotherapy for prostate cancer, its Provenge vaccine seemed likely to win FDA approval five years ago until an unusual turn of events prompted the agency to issue a delay.
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