Yes they plan to submit in Q1 '13 based on current data and not wait for extension or any of their other trials.
They will also use their Novato manufacturing plant initially with plan to change to their Pfizer acquired (Ireland) facility (with a much lower tax rate) at a later date. Also said pricing will be in the Naglazyme/Aldurazyme range. Even though higher dose than Naglazyme should have better cell line yield and lower COGS.
I haven't had a chance to go over the call more closely or look at the data comparing with some other ERT's. My initial impression though is it compares well to some off the top of my head Naglazyme didn't hit on 6MW (close) having a large sample size certainly helped here.
The 4mg/kg/week dose being tested (I alluded to in a prior post) is in a small pilot study (again not intended to be dose they go with for initial approval). My sense is that (like some other ERT's) this may show better efficacy. May be a better question for you or genisi but wondering if the nature of the disease where drug is needed most its harder to get into those cells.
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