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Post# of 19309
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DewDiligence

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DewDiligence

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Re: DewDiligence post# 13713

Friday, 11/07/2008 12:28:20 PM

Friday, November 07, 2008 12:28:20 PM

Post# of 19309
When will Ovation pay ATryn milestones?

[Updated for milestones already paid.]

$9M of the $257M total potential milestones pertains to the HD indication:

• $5M already received
• $1M on positive opinion from FDA advisory panel
• $3M* on FDA approval of BLA
[*$4M if FDA overrules a negative panel vote.]

The other $248M consists of undisclosed amounts triggered by three clinical/regulatory milestones for the DIC indication and undisclosed annual sales-based milestones on a nine-tier schedule that apply when sales in the preceding year exceed an undisclosed threshold. There are no clinical/regulatory milestones for the CABG/HR indication.

The three clinical/regulatory milestone triggers for the DIC indication are: i) establishment of a mutually agreeable clinical-development plan (including LFB if the development plan is global); ii) FDA acceptance for review of the sBLA; and iii) FDA approval of the sBLA.

http://sec.gov/Archives/edgar/data/904973/000119312508170051/dex101.htm

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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