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Biotech / Medical : CLTR COULTER PHARMACEUTICAL

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To: Biomaven who wrote (336)9/29/1999 11:31:00 PM
From: Vector1  Read Replies (1) of 666
 
Peter,
i am just sick over this. I believe that BEX is a significant advancement in the treatment of low grade NHL,is approvable and will generate substantial sales. At current levels the stock price is ridiculous. I have seen numerous other companies have problems with the FDA. CGPI went through hell getting Periostat approved and the delay cost them a year. The fact of the matter is that the FDA change the rules in the middle of the game all the time. However, I have never seen a company have so much trouble just getting a BLA filing accepted. Apparently the FDA was willing to meet earlier but CLTR demanded senior FDA officials at the meeting and the delay was caused to make sure these senior FDA officials could be there. The company announced this at the Warburg Dillon Reed conference yesterday which explains when the weakness started.
Just my opinion by I think that CLTR must believe that some or one of the junior FDA people have not been straight with them and they are making sure that the bigwigs are at the meeting. It may have caused another delay but it may also be a smart strategy.
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