smallinvestor,
Just some observations on your item #3.
The judge has no factual basis for thinking that the 2 companies would "split" US (Increlex) vs. Europe (Iplex).
The European Iplex approval is not likely to block Increlex from the market. Same as when US Increlex approval did not block Iplex due to 1st approval in the US. The two drugs were clearly found to be "not the same" by FDA, so "orphan block" did not happen.
The EMEA is likely to see it this way too - because of the science. The proposed international nonproprietary names for these two products are different; the concentrations are different; the daily dosing range is different; the dosing interval is different; the side effect frequencies are different. FDA actually stated in writing that Iplex is viewed as a two active ingredient fixed-dose drug product, whereas Increlex is a single ingredient product. Therefore "Orphan Exclusivity" is not likely to apply in EU, just as it did not in US.
The main European issues I see as basically straight forward commercial ones-
(i) How much of a 1st approval marketing advantage can Insmed achieve?
(ii) Who will manufacture Iplex for Europe? and
(iii) Who will be the partner for Europe?
Wilken has no duty to consider any of that. But if she was inclined to consider these "off the docket" issues, the two drugs do not appear to "block" each other in terms of "orphan drug" rules, so I don't see her placing much value on those issues. I think her main consideration at this point is the 3 judge court of appeals.
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