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Post# of 252218
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Thursday, 03/15/2018 6:46:03 PM

Thursday, March 15, 2018 6:46:03 PM

Post# of 252218
Phase 3 Different trial designs by companies

What does one think when two companies with similar programs have different Phase 3 plans particularly on the primary end point. Especially when the design of one would lead to a significantly faster timeline. Does it speak to the competence/relationship with regulators of one vs. the other? Are there legitimate reasons this could happen? Since its Phase 3 I doubt one is directly lying about agency guidance but perhaps stretching things a bit?

The question is general in nature but what prompted my question is thinking of the difference between QURE and BMRN (granted one is Hemophilia A the other is B).
QURE primary Bleeds (6 month run-in to measure bleeds)
BMRN primary change in Factor level

Note both have others primary as secondary though BMRN uses "well documented" history (no run in) to measure bleeds. Both also measuring amount of Factor replacement used amongst other things.

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