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Biotech / Medical : Zonagen (zona) - good buy?
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To: Brander who wrote (2890)3/20/1998 11:09:00 PM
From: Hank  Read Replies (3) of 7041
 
These are all after the fact data points that have been revised post FDA approval. The initial data on Zoloft showed no incidence of headaches and a far lesser degree of impotence. You say the data is clinically insignificant. Lets say you have 1000 depressed patients. Half are treated with Zoloft and 20% have headaches. The other half are treated with Paxil and 0% have headaches. From an NDA submission standpoint, are you saying this is clinically insignificant? The FDA has to make a decision on what data is available AT THE TIME OF SUBMISSION. They can't see into the future and tell what the percentages will be once a million or so patients have been treated.

If you REALLY want to complicate matters we can now get into Prozac. Insomnia- 28%. Anorexia- 11% There is clearly a difference between each drug when the NDA's are submitted. All you have to do to verify this is look at the earliest published clinical data on each of these drugs.

Hank
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