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Old 02-06-2009, 06:53 PM
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lady_express_44 lady_express_44 is offline
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Join Date: Aug 2006
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Posts: 3,300
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Quote:
Originally Posted by komokazi View Post
They have discontinued reporting individual PML cases on 8-Ks. Actually makes a great deal of sense since I know of no other drug in the entire drug universe where individual drug adverse events (that are listed in the label) are reported on 8-Ks much less in a weekly report on the company website.
These 8-K filings were made for the following reason:

"Form 8-K is the “current report” companies must file with the SEC to announce major events that shareholders should know about."

In the case of announcing PML cases, it fell in the following category:

"Section 8 -- Other Events
Item 8.01 Other Events (The registrant can use this Item to report events that are not specifically called for by Form 8-K, that the registrant considers to be of importance to security holders.)"

The medical, patient and shareholder community value transparency, and very public reporting of this information . . . even if Biogen's "marketing efforts will continue to focus on the 'efficacy story', education on PML, and placing PML management in the context of the overall product."

http://seekingalpha.com/article/1190...nscript?page=1

Cherie
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