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

To: aknahow who wrote (6862)	7/15/1999 4:27:00 PM
From: Biomaven	Respond to of 9719

george, Basically you always give up something if you unblind early. If the results when you peek are bad, the FDA will still use them against you. If the results are good, they will be discounted by the FDA because of presumed bias by unblinded investigators. Peter

To: aknahow who wrote (6862)	7/15/1999 9:56:00 PM
From: hm	Respond to of 9719

> 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. Not to belabor this too much ... but it looks as though the trial's primary endpoint was assessed at, say, 3 months with a long term evaluation done at say 6 months. The sponsor certainly wouldn't want to unblind the trial prior to all subjects completing the 3 month eval. - well they could if they wanted to get a thin letter from the FDA. In this situation, it looks like the sponsor / investigators stopped the trial right after all completed the 3 month endpt & accepted that they were only going to have 6 month data on some patients. This is OK especially if it's pre-specified in the protocol. The 6 month data can still be used as a secondary outcome measure. It certainly has to be filed for safety info. Hank