Xenacare Holdings Inc.(fka XCHO)

[gator97]

I don't appreciate you saying I am biased. I am not. You deal in facts and your opinion on me is just that. Here's a fact: all drugs are "promising" until they are found to have problems. Check these facts on drug approval:
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
And...
"The FDA is being more cautious," analyst Steve Brozak of WBB Securities said, explaining that FDA staff now realize new drugs will be used by many patients beyond those intended — known as off-label use because the drug is taken for another condition than the one it was approved to treat. That often boosts the chances that some patients will be harmed by side effects.

He sees the FDA mentality now as: "It's got to be so safe that we're not going to be criticized ever" for approving a drug.

The agency has approved 61 percent of drug applications through mid-August, down from 73 percent in the same period last year, according to BioMedTracker, a biotech and pharmaceutical research service.

Already, the average process of shepherding a potential drug from discovery through approval takes 14.2 years, according to Tufts.

Some patients and their families say that can be too long. Frank Burroughs' daughter, Abigail, was denied access to experimental cancer drugs and died in 2001. The drug she was seeking was later approved. He went on to found an organization that sued the FDA in 2003 seeking access to experimental drugs for terminally ill people. Earlier this month, the court ruled that dying patients don't don't have the constitutional right to potentially lifesaving drugs that haven't been approved yet by the FDA.

“Terminally ill patients desperately need curative treatments,” Judge Thomas B. Griffith wrote for the majority. But “their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit.”

James Kumpel at Friedman, Billings, Ramsey & Co. just published a report showing FDA approvals of "new molecular entities" — drugs made from new chemical compounds rather then just twists on existing drugs — so far this year are at their lowest level in at least a decade. Only seven were approved through the end of July, versus an average of 12 over the first seven months of each year since 1998.

"The FDA certainly has made it more difficult for pharmaceutical companies by pushing for more data and for more participants and for longer studies," said Kumpel, barriers he said will start limiting the number of new blockbusters.

"It appears that FDA has been on defense since 2004," Kumpel said.