V-Man<<)Why didn't Pfizer include the at risk group(men with CVD) in their phase III clinical trials on Viagra?>>
At risk patients are usually never included in Phase III studies I believe this was true for all the MUSE Phase III studies.
V-Man<<2)Do you feel that Pfizer made an "honest" mistake and was unaware that most men with organic impotence have CVD?>>
No.
V-Man<<)Why did the FDA allow a non life saving lifestyle drug such as Viagra fast track approval while other drugs that were designed to alleviate more severe diseases which create pain and suffering have to wait one year or longer before getting FDA approval?>>
The same reason they gave MUSE expedited review. "Life-saving" aspects of a potential NDA are not included in the parameters for determining priority review. Here is the official FDA criteria:
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Priority Review Classification: A determination that is made based on an estimate of its therapeutic, preventive, or diagnostic value. The drug product, if approved, would be a significant improvement compared to marketed products (including non-drug products/therapies) in the treatment, diagnosis, or prevention of disease.
Improvement can be demonstrated by:
1. Evidence of increased effectiveness in the treatment, prevention, or diagnosis of disease.
2. Elimination or substantial reduction of a treatment limiting drug reaction.
3. Documented enhancement of patient compliance.
4. Evidence of safety and effectiveness of a new subpopulation.
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V-Man <<4)Once Pfizer realized that a disporpotionate number of men were having coronaries, why did Pfizer not take the SAFEST action and voluntarily black box Viagra to inform physicians to avoid using it in the CVD patient until further studies could prove or disprove safety in this particular group?>>
Based on FDA actions and the recent AHA/ACC review, YOUR realization has never been established.
V-Man<<5)Why after over 200 deaths and thousands of coronaries later hasn't Pfizer been willing to announce that they are going to commit R&D to a double blind study of Viagra on this at risk group?>>
Don't know ....and I'm sure no one is going to tell me Viagra's current or future clinical program.
V-Man <<6)Are there currently PROVEN safer ED therapies on the market for ED patients to use?>>
Impossible to tell..since there are no comparative studies among oral medications and other non-oral ED products...Given their distinct modes of administration, there probably will never be any clinical evaluations.
V-Man <<I bet that if you didn't own stock in Pfizer and a close relative or friend used Viagra and died you would be singing quite a different tune about what went down with Viagra. C'est la vie.>>
Of course I disagree..If you check out the rest of the world outside VVUS Boards, there is hardly this outrage against Viagra as you indicate by your posts.
V-Man <<Unfortunatly, I did my DD on the product but I happened to overlook the management side of the company.>>
V-Man: Hard to believe their management ability was a big surprise to you.
April 12,1998 www3.techstocks.com
July 11,1998 www3.techstocks.com
Have a great holiday!
BigKNY3
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