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Biotech / Medical : Zonagen (zona) - good buy?
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To: Claud B who wrote (6742)5/12/1999 7:47:00 PM
From: Tokyo VD  Read Replies (2) of 7041
 
Claud,

Unfortunately, you are wrong. The FDA does not reject drugs outright. They issue non-approvable letters. The reason they issue non-approvable letters is that the data submitted by the drug company doesn't meet the safety and efficacy standards established by the FDA.

A drug company amend an NDA with new studies that demonstrate outcomes that are different than the previously submitted NDA package, but that takes time and coordination.

IF Zonagen/Schering have undertaken such studies, then Zonagen/Schering had obviously concluded that the feedback they were receiving from the FDA regarding their NDA was not favorable. This unfavorable feedback leads the FDA to invite Zonagen/Schering to attend a panel meeting of sub-specialty experts (urologists). This panel would hear the reasons why FDA statisticians and investigators believe the drug did not achieve safety and efficacy marks that warrant approval. Zonagen/Schering would be asked to present their position in defense of the data that it submitted. Zonagen/Schering chose not to defend the application. Therefore, the FDA has no choice but to issue a non-approvable letter based on the data submitted.

The FDA does not issue non-approvable letters based on a drug company's decision not to defend its application.

Tokyo

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