GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Possible / Probable News Flow

[Added item #3 on submission
and acceptance of ATryn BLA.]

1. A partnership for ATryn in the US. This is apt to be the most consequential news item of the next 12 months. It could come at any time (#msg-21999558).

2. 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.

3. Submission and acceptance of the ATryn BLA for review. Submission is expected toward the end of 1Q08 and acceptance of the BLA for review occurs approximately 60 says after submission. The relevance of the acceptance-for-review date is that the FDA decides whether to conduct a Priority Review at that time. (Priority Review shortens the review time from 10 months to 6 months.)

4. A new supply deal similar to the one with Merrimack. The effect of such an announcement on the stock price could be large, depending of course on the partner and the partnered drug.

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.