In light of your post and conclusion, CP, we can easily see why Dr. Garnick et al have told us that >>500,000 pages had already been submitted to the FDA---and if I remember correctly, that fact was made known to us about 18 months ago at the 2014 ASM. Perhaps we now better understand why the Sunrise Phase 3 Study[last verified and updated February 1, 2016] reads "This study is ongoing, but not recruiting participants". No doubt many more pages have already flowed, and will yet flow, to the FDA.
I will not speculate here what indication(s) any BLA submitted will recite.
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