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ghmm

03/31/11 3:08 PM

#117378 RE: genisi #117375

Good to see your confidence :-).

I guess I am just the cautious type and never count my CHO cells till they are commercialized :-). I believe ERT's to enter Phase 3 are something like 6 for 6 (maybe I am missing some?). The 36 week walk distance dropping is obviously a bit of a concern (even though the company gave reasons). The two arms also has me wondering if the company is more concerned about injection site reactions then they are letting on. A couple of other little things concern me a bit too.

I think even if they miss (not that I expect it) on 6MWT if its trending and the secondaries are trending it will (eventually) get approved. They have good anecdotal data in one patient who was wheel chair bound before starting (in the P1/2) and now can walk. Plus I figure regulators realize ERT benefits are more broad and more evident over time.

EDIT:

Forgot PLX do we count that as an 0-1 or are they still up at bat :-)