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Biotech / Medical : dsco Discovery Laboratories

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To: Biotech Jim who wrote (237)4/22/2009 11:43:39 AM
From: kenhott1 Recommendation   of 318
 
I have not listened to the CC because it is not near the top of my big stack. My thinking is that there is something fundamentally wrong with this drug/application in the eyes of the FDA instead of just someone at the FDA playing the bad guy.

No matter how big an organization, people and their managers make the decisions. One strong opinion at the FDA can substantially influence a drug application. But the FDA is a fishbowl and no single person/small group can "get away with" doing this to DSCO at the agency without the reasons going up the management chain. I find it unlikely that the entire FDA organization is out to get DSCO. So I believe while people may find the FDA reasons to be not well balanced, for instance, DSCO is not going to win that type of argument at this point.

I get to a conclusion that the problem is at DSCO and DSCO is probably stuck. Company is saying that the FDA not bringing new issues is a good thing. But the flip side of that is the FDA is not moving on the old issues and DSCO can't find the right answers.
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