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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?


To: Arthur Radley who wrote (1773)12/31/2001 4:28:47 PM
From: keokalani'nui  Read Replies (2) | Respond to of 2515
 
I don't disagree with your overall point. But BMS probably did not have much if any influence over the filing, and likely relied on management's self-confidence. BTW, BMS doesn't owe any milestones until after acceptance of the filing.....

And though I am not sure the source of your quote (journalist?), what was missing was the raw data necessary for an independent expert to verify the conclusion reached by the investigators and IRC. Or, in other words, was refractory refractory and RR RR per protocol? There apparently was plenty from the investigators and the IRC on their final conclusions, there just weren't any radiologic films, etc., to confirm that THEY did it right.

Still, the failure to assume that the FDA would be making up its own mind is really stunning. Maybe you are right, perhaps the P2 irrinotecan refractory trial was just a total rush job and is in fact fatally imprecise. That WILL provide a buying oppy if we find that out in 8 weeks, for I do believe the drug works.

Maybe imcl will be acquired by Corixa next year. Just kidding...

Wilder



To: Arthur Radley who wrote (1773)12/31/2001 4:56:56 PM
From: Labrador  Read Replies (2) | Respond to of 2515
 
>>there is no DAMN excuse that IMCL shouldn't have known what was expected of them in this filing. All the spin in the world and with BMY looking over their shoulder, there is no way to explain that they didn't merely overlook this data..<<

Suppose that maybe IMCL and BMY [and key personnel and the FDA] knew and that's why the stock fell from over $70 to $55 BEFORE the news got out to the public. Rumors were all over the place for the last two weeks that the application was to be rejected. Probably Company officials were trying to sway the FDA, so outside counsel/accountants etc knew. Smart money knew the rejection was coming, but joe public is the last to know.

The SEC should investigate this but they won't.