Here's the Lehman quote:
Lehman Brothers' Ende said Coulter officials told him this morning that they expect to resubmit the marketing application to the FDA by mid-October and expect to see Bexxar launched in the United States by next April.
As a result of the delayed launch, Ende said, he is cutting his 2000 sales forecast for Bexxar to $66 million from $123 million, and reducing his 2001 forecast to $137 million from $199 million.
''I now don't expect the company to become profitable until 2002, whereas initially I expected Coulter to start making money in 2001,'' the analyst added.
He said Coulter officials had told him the FDA had requested changes in seven areas. ''None of them appear serious on the surface, but when you add them up they create more risk,'' he said. ''They make you wonder if the FDA later will want yet more data.''
Among the items requested by the FDA is more data on how radiation from Bexxar affected organs in the body, he said. ''Coulter claims to already have the data,'' Ende added.
If they are really going to get it out by mid-October, then this does indeed imply pretty minor changes.
So here are the two opposing views:
Long: This is the FDA just being bureaucratic. Bottom line is a few months delay - i.e., nothing of lasting significance.
Short: This confirms that there this something fundamentally wrong, and the company is just trying to cover it up. The FDA wouldn't delay a treatment they thought was significant for just minor reasons.
I'm currently tending to the "long" side, but some smart people I know are tending to skepticism.
Peter
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