Possible / Probable News Flow
[Updated re timing of announcements.]
1. Reporting of top-line data from the US ATryn trial. Expected any day.
2. A partnership for ATryn in the US. Inasmuch as the top-line data from the US ATryn trial are due any day, I expect a US partnership announcement will come after the top-line data release. The partnership will presumably cover development and commercialization of all indications for ATryn in the US, not just the HD indication.
3. A partnership for ATryn in Japan. Japan has substantial sales of plasma-derived antithrombin, including an approved indication for DIC/sepsis. These plasma-derived sales represent low-hanging fruit for eventual conversion to ATryn. At least one Japanese clinical study (by a GTC partner) will be needed to obtain marketing approval.
4. Submission and acceptance of the ATryn BLA for review. Submission is expected in mid 2008 and FDA acceptance of the BLA for review occurs approximately 60 days after submission. The relevance of the acceptance-for-review date is that the FDA decides at that time whether to conduct a Priority Review, which shortens the review time from 10 months to 6 months.
5. A development partner for the CD137 program. This would be significant because CD137 is the most advanced internal program that is not based on a plasma protein.
6. Something out of the blue. With a company such as GTC that has so many possibilities, it’s not unreasonable to expect the unexpected.
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