>One of the problems with calibrating the FDA is that you only get to see the FDA's side of it when the drug is eventually approved or when it makes it as far as an AC.<
There’s a third way: when the fallout is so severe that Congress holds public hearings to find out what went wrong. This is how the FDA’s side of the Erbitux debacle came to light in 2002.
Your main point is well-taken and is the reason I generally reserve FDA bashing for cases where a drug is already approved in at least one major jurisdiction such as the EU.
CHICAGO, Dec 13 (Reuters) - Epix Pharmaceuticals Inc. ( EPIX ) said on Tuesday it will cut about half of its work force next month after U.S. regulators last month said the company would need more clinical data before it would approve the company's lead product, Vasovist.
Epix said the reductions will affect the research and development and the general and administrative areas of the company. After the job cuts, Epix expects to have about 48 employees.
On Nov. 22, Epix got a second so-called "approvable letter" from the U.S. Food and Drug Administration, requesting additional data from the company. Vasovist is intended to help enhance images taken in conjunction with magnetic resonance imaging or MRI.
The Cambridge, Mass.-based company, said its spending next year will highly depend on anticipated FDA input on future trials of Vasovist. Epix said it expects the job cuts to reduce by 30 percent, or $7 million, its 2006 cash burn rate -- meaning the amount of cash spent each year on operations, excluding cash payments related to the job reductions.
Epix said it would take a fourth-quarter charge of $1.2 million in connection with the work force reductions. <<
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