Don't forget the partnership agreement between Optimer and Astellas to market Dificid in Europe. If the drug receives full approval in Europe, and there is a very good chance of this happening based on the approval by the European Advisory board last month, then Optimer will receive an upfront payment of 50 million Euros immediately, with milestone payments based on territorial sales later. December 23rd is the date by which full approval could be granted.
Below is an excerpt from the Agreement:
In return for an exclusive license to fidaxomicin in the territory, Astellas is obligated to pay Optimer an upfront cash payment of approximately $68 million. Optimer is also eligible to receive additional cash payments totaling up to approximately $156 million upon the achievement of certain regulatory and commercial milestones. Furthermore, Astellas is obligated to pay tiered double-digit royalty payments on net sales of fidaxomicin in the Territory. Astellas will be responsible for all future costs associated with the development, manufacturing, and commercialization of fidaxomicin in the territory including the costs of the ongoing Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).
If Astellas does not see the revenue expected in the US, Astellas reserves the right not to excercise the right to market exclusivity in Europe. That would leave OPTR with $0 upfront payments and certainly $0 milestone payment. Everything hinges on US sales and the earnings in December. There is alot riding on US sales. European approval is the least of OPTR issues.