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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)
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To: Tunica Albuginea who wrote (4089)1/1/1998 11:08:00 AM
From: MissLil  Read Replies (2) of 23519
 
Here are the problems with the Urology study:

1. "Control" is patient's self-reports of success with injection of undefined drugs. Need defined control and/or active drug.

2. Proper design for this is "double-blind, double-dummy". i.e. neither the investigator nor the patient knows whether he is receiving active drug. All patients should receive both and injection (of either placebo or active drug) and intra-urethral insertion (of either active drug or placebo).

3. The definition of patients with ED is not defined. Therefore it is impossible to decide to which group of patients (if any) this studies applies.

4. Dose titration does not look particularly rational to me (I'm not a urologist).

These are a few of the problems that occur to me with a quick look.

If a company submitted this study to the FDA in support of an application, the medical reviewers would all have a good laugh, right before they rejected it .

(My personal opinion only, not official agency policy).
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