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


To: Labrador who wrote (1776)12/31/2001 5:05:37 PM
From: Arthur Radley  Read Replies (1) | Respond to of 2515
 
Lab,
I don't think the rumor tag can be placed on this issue. The FDA has very clear rules and everyone knows that they have 60 days to respond to a filing request. The big Wall Street firms and analyst keep a close eye on the daily filings and issuances coming from the FDA and biotech firms. It was no secret that IMCL apparently had problems because everyone paying attention knew the time was coming to an end of the 60 day time frame. Remember! The CEO had clearly stated that because of the way they filed their documents it allowed them the opportunity to work closely with the FDA on each step of the process...therefore, the CEO had to have known that something wasn't right before last Friday night....or it means that their efforts to work close with the FDA was a bogus claim in the first place...or it means the FDA had it out for IMCL and colon cancer patients. Which do you believe?



To: Labrador who wrote (1776)1/7/2002 8:37:32 AM
From: Arthur Radley  Respond to of 2515
 
Seems that what I was suggesting back in December is NOW coming true..

"On. Dec. 31, U.S. regulators said they would not accept the firm's application to sell the colon cancer drug, which is being co-promoted with Bristol-Myers Squibb Co. (NYSE:BMY - news). Details of the U.S. Food and Drug Administration's refusal-to-file letter were released on Friday in The

Cancer Letter, an industry newsletter.

``We believe the details disclosed in The Cancer Letter article suggest additional deficiencies in ImClone's biological license application (BLA) beyond those already disclosed by the company in its conference call on December 31,'' J.P. Morgan said in a research note