Saturday, July 16, 2005 4:23:16 AM
Hi Dew,
I haven't found out the 'reply to none' trick, so I will add some info on GTCB and antithrombin this way.
You probably know that plasma derived antithrombin is made commercially available in Europe under the trade name ATnativ by Baxter. What I just learned is that another big, but to me relatively unknown company, by the name of Grifols is marketing plasma derived antithrombin under three different brand names. Their most advanced en newest product (in terms of safety, side effects and shelf-live)is called Abinex (You can check out their website). This made me wonder about the real marketpotential for Atryn in Europe, since Abinex can probably be used off-label for the same indications as Atryn. I believe that Grifols might also want to target the US market with this product. I am curious about your view on this.
Another thing I learned is that the EMEA CHMP Blood Group Working Party will probably evaluate the MA application of GTCB and those guys will not convene as early as half september (you can check out the EMEA website for this), so I find it very hard to believe that the CHMP will make a recommendation before half october, first awaiting the opinion of their most important working group.
The last thing you should check out is the following site:
http://www.fda.gov/cber/summaries.htm
Please take a look at the presentations of Dick Scotland, Chris Healey and Rainer Seitz and let me know if you found these informative. I did. There are also some other interesting presentations. Some DD for the weekend I should say
Regards,
Elmono
I haven't found out the 'reply to none' trick, so I will add some info on GTCB and antithrombin this way.
You probably know that plasma derived antithrombin is made commercially available in Europe under the trade name ATnativ by Baxter. What I just learned is that another big, but to me relatively unknown company, by the name of Grifols is marketing plasma derived antithrombin under three different brand names. Their most advanced en newest product (in terms of safety, side effects and shelf-live)is called Abinex (You can check out their website). This made me wonder about the real marketpotential for Atryn in Europe, since Abinex can probably be used off-label for the same indications as Atryn. I believe that Grifols might also want to target the US market with this product. I am curious about your view on this.
Another thing I learned is that the EMEA CHMP Blood Group Working Party will probably evaluate the MA application of GTCB and those guys will not convene as early as half september (you can check out the EMEA website for this), so I find it very hard to believe that the CHMP will make a recommendation before half october, first awaiting the opinion of their most important working group.
The last thing you should check out is the following site:
http://www.fda.gov/cber/summaries.htm
Please take a look at the presentations of Dick Scotland, Chris Healey and Rainer Seitz and let me know if you found these informative. I did. There are also some other interesting presentations. Some DD for the weekend I should say
Regards,
Elmono
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