Unlike a Fast Track designation, which is all but meaningless, an Orphan Drug designation is consequential.
By granting ATryn an orphan designation even though a plasma-derived antithrombin (Talecris’ Thrombate) is already approved in the US for the HD indication, the FDA is implicitly stating that the benefits of a recombinant drug vs a corresponding plasma-derived drug are substantial.
We already knew this (#msg-23864419), but today’s news is a clear indication that the FDA knows it too.
So the two things from this announcement that jump out at me are that: 1.) GTCB may have saved the FDA fee of $1,178,000 with Orphan drug status. That is not a small amount to this company. 2.) The time line for top-end data just slipped into Jan. 08 from end of 2007.
I am looking for an announcement in early January on the top-line data now as before I was hoping for something before XMAS.
If this is the case I would not be surprised to see the PPS drift lower as it did today.
The open question is will the partnership come through before the top-line data is made public. They did project revenue in the 4th quarter from a such a partner in the last CC. Maybe this projection has slipped as well?
IMO as each day passes toward the end of the year without a partner the downward pressure on the PPS will continue.
I have funds to add to my share count but am betting that we drift lower through the next week before XMAS without a partner announcement.
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