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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)
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To: BigKNY3 who wrote (5485)2/17/1998 3:25:00 PM
From: Tunica Albuginea  Read Replies (2) of 23519
 
BigK, several friendly replies and comments for you:
Question:
"Question: PFE has submitted data on over 4,500 patients to the FDA. I have only seen you comment on only one study with 12 patients. Do you really know what was included for the other 4,486 patients?".

Answer; exactly, how did the ED community conclude already ( 8 months ago, before any data were out ) that Viagra was safe and effective in the long run? I say let's see the data.

Question;
"Question :Are echocardiograms required on all NDA submissions? Do you know if echocardiograms were conducted on Phase III MUSE studies?"

Answer: No; but they would have been if Amer Home products had submitted to the FDA the European cases of people having chest pain and valve irregularities. they didn't. AHP quashed the data.

Question/comment:
" A correction: Redux valve irregularities were not discovered in Phase IV studies but by individual physician reports requested by the FDA from Phase III investigators."

Answer: Wrong. See previous reply. Data were known in Europe.AHP quashed those reports. i believe the FDA even disregarded I believe their own Advisory Committee's reccomm not to proceed with Redux pending further studies.

Question:
"TA << I will be talking with some more ophthalmologists and PhDs
doing molecular bioresearch. >>
Question: How can we evaluate the quality of your unnamed
references".

Answer: Good question. I will try and name those references if I can. I will quote the available research if I can as given to me by them.

Question:
"Given your apparently large financial position in VVUS, do you think you are biased in your evaluation of MUSE and oral ED products?"

Answer: No more biased than somebody holding a large position on the competing Pfizer product Viagra < GG >. ( got you there Big K. )

Here is my most recent research :

Message 3453499

TA

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