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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: aknahow who wrote (6858)7/15/1999 12:50:00 PM
From: biowa  Read Replies (1) of 9719
 
George,

Two points, IMO:

1) No one gives you permission to unblind early, that's a decision you could make (hopefully done in consultation with the FDA and all of your investigators; and you better have a good reason).

2) If by "look-back points" you mean long-term follow-up, that can be done after unblinding.

There are also indications and therapies where the FDA might consider (very infrequently) single-blinded studies, etc. for approval. So you may want to be careful in assuming something is fishy (unless it smells bad otherwise...)

biowa
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