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Old 02-06-2009, 02:22 PM #1
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I just read in the Wall Street Journal that Biogen reported that the European patient was on Tysabri for 12 months. Somehow I can't cut and paste the link burI am sure others on the forum will be digging around and posting more information.
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Old 02-06-2009, 03:20 PM #2
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I can't find anything on the WSJ website about this. I did see it on the Reuters link though. It looks like the projected revenues aren't doing so well. I hope it doesn't mean there will be another big price increase for those of us on Tysabri.
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Old 02-06-2009, 03:30 PM #3
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Default Good chart from BiogenIdec Earnings Presentation

http://idea.sec.gov/Archives/edgar/d...73936z0016.gif


4 out of the 5 patients who developed PML are alive. They will update on the patients at a scientific conference.

They are working to identify new methods of risk assessment. In the Q & A they hoped to be testing these methods by mid-2009.

Other items I note

4 out of the 5 PML cases have occurred in European patients. The US TOUCH program would seem to offer PML risk reduction.

4 of the 5 cases occurred between 12 and 17 months of treatment. The risk of PML would appear to not increase with increasing time on drug - only 1 case in patients with over 2 years of exposure.
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Old 02-06-2009, 03:38 PM #4
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They usually post on their site every Friday afternoon, re: new cases. The list hasn't been updated for this week yet.

They were still squabbling over the "denominator" for calculating the PML risk ratio in the 2008 4th quarter conference call this morning, BUT they did not debate that there have now been 8 cases (3 in the trials, 5 since):

http://seekingalpha.com/article/1190...age=-1&qa=true

Guess we'll have to wait till later today to find out if they've reported it on their site yet . . .

Cherie
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Old 02-06-2009, 04:16 PM #5
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Default The list is updated at 4:30 PM Eastern Time on Friday

Cherie,

The lsit is updated at 4:30 PM EST.

Chris
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Old 02-06-2009, 04:34 PM #6
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Wiz, here is the link to the WSJ article.

http://online.wsj.com/article/BT-CO-...06-706910.html

You'll find information about the patient getting PML after 12 months at the very end of the article. At the time, I was on my iPhone looking at it and couldn't figure out how to cut and paste.
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Old 02-06-2009, 05:43 PM #7
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Quote:
Originally Posted by komokazi View Post
Cherie,

The lsit is updated at 4:30 PM EST.

Chris
Thanks Chris.

Do you happen to know what the timing is for filing the 8-K with the SEC?

http://www.sec.gov/cgi-bin/browse-ed...art=0&count=40

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Old 02-06-2009, 05:47 PM #8
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Default No more 8-Ks, just the weekly update on their website

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.
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Old 02-06-2009, 06:53 PM #9
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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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Old 02-06-2009, 05:58 PM #10
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So, if you go by the numbers Riverwild posted, you have 8 people getting PML out of almost 40,000 on the drug?

However you disect the numbers, that is still pretty rare.

My neuro was just telling me at my appt. yesterday that in his research that an acceptable number could be as high as 7 out of 1,000 risk and it would still be beneficial to be on the drug. I don't know that I agree with that, but he must be looking at it from a practicioner's point of view.

I guess if it meant life or death kind of a situation, I would agree. But MS is such an unusual disease with many different manifestations in different people.

I just have to look at my life, and what it is doing for me. I'm not worried about getting PML, and MS is not really affecting my life in any great way. If Ty keeps it that way, then great!

Having said that, I'll be having my first MRI after being on Ty for 10 months. I'll let you know how that turns out on Monday!
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