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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?


To: biowa who wrote (6859)7/15/1999 2:56:00 PM
From: aknahow  Read Replies (3) | Respond to of 9719
 
Thanks, not assuming anything fishy, however.

Really just want to know more about the process. In one specific situation Murphy saying that the long term follow up data cannot be used for the filing, period. Meaning that some long term data already existed prior to the unblinding and some did not as the follow up point had not been reached by all at the time of unblinding.

Now, I have two opinions, from posters i both respect one saying only the FDA can authorize unblinding and yours which says company makes the decision but if they are smart they will do it with consultation of FDA and investigators.

In a way this really is about the same as the FDA. Sort of like saying you can decide on your own not to go to a grade school class but you ought to ask your mother.