The collaboration arrangement with Merck includes milestone payments of approximately $880.0 million. These milestones consist of development milestones of approximately $380.0 million and sales-based milestones of approximately $500.0 million. The development milestones range from $5.0 million to $45.0 million and are based on the commencement of a new phase of clinical trials for specific indications, filing for approval in the U.S. or major countries in Europe for specific indications and approval in the U.S. and other major countries. The Company evaluated each of these milestone payments and believes that all but one of the milestones are substantive as there is substantial performance risk that must occur in order for them to be met as they must complete additional clinical trials which show a positive outcome or receive approval from a regulatory authority and would be commensurate with the enhancement of value of the underlying intellectual property. The non-substantive milestone is $5.0 million and once earned will be combined with the other consideration received in the arrangement, being the license and research and development reimbursements, and under the cumulative catch-up approach will be recognized on a straight-line basis during the performance period. The $500.0 million of sales-based milestones will occur after development milestones are achieved, and the Company will account for these in the same manner as royalties. The sales-based milestones would be achieved if certain sales thresholds are exceeded for worldwide sales of vintafolide and etarfolatide. To date, the products have not been approved and no revenue has been recognized related to the earnings split on U.S sales, development milestones, sales-based milestones or royalties.
Seriousjust, not sure why you think the product development milestones are just for SCLC and PROC. The collaboration agreement (August 10Q Exhibit 10.21 page 47) has 25 confidential censor asterisks for product development milestones. So, unless there are 25 possible milestones for two indications of SCLC and PROC already in phase 2/3, I think it's more likely that there are milestones for all 6 indications. Per Mike Sherman on the November 1st CC, Merck is starting a clinical trial in brain cancer (new indication) as part two of a two part dose escalation trial. According to clinical trials, that's supposed to start recruiting this month, so if part two of the trial counts when part 1 is started, then I think we might get a milestone payment in November, perhaps the non-substantive milestone of 5M.
Additionally, I read from the wording of the current 10Q that filing for approval in the EU is a milestone. If so, I think that happens soon also, as, well... what are they waiting for!