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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)

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To: Tunica Albuginea who wrote (5486)	2/17/1998 6:51:00 PM
From: BigKNY3	Read Replies (1) of 23519

TA : Here's some additional friendlier comments and questions: <<BigK, several friendly replies and comments for you:>> BigKNY3 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?". TA :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. BigKNY3 Comment: Most of the positive comments are from the Phase II and III Viagra investigators who have seen their data. I agree with you that soon everyone will want to review this data and will have an opinion. Right now it's in the FDA being reviewed. BigKNY3 Question; "Question :Are echocardiograms required on all NDA submissions? Do you know if echocardiograms were conducted on Phase III MUSE studies?" TA 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. BigKNY3: Do you have evidence that this happened? Please provide a reference. BigKNY3 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." TA 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. BigKNY3 Comment: I stand with my original statement that the problems with Redux were not revealed in Phase IV studies but from patient reports that were initially submitted by the Mayo Clinic and then from "five physicians who had performed echocardiograms" on their Redux and fen-phen patients. Here is the FDA website concerning this matter. Please note the answers to questions #4 and #5. fda.gov BigKNY3 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". TA 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. BigKNY3 Comment: Thanks. I would also be interested if they have had experience with Viagra. BigKNY3 Question: "Given your apparently large financial position in VVUS, do you think you are biased in your evaluation of MUSE and oral ED products?" TA Answer: No more biased than somebody holding a large position on the competing Pfizer product Viagra < GG >. ( got you there Big K.) BigKNY3 Comment: I believe anyone who invests in a stock is biased to that company and their products including myself.( After holding PFE for over 20 years, it would be very hard not to be biased.) Hopefully, readers understand that physicians have honest different interpretations of clinical data ...which may be further complicated if the physicians have financial interests in the company via stock ownership. TA:Here is my most recent research : Message 3453499 BigKNY3 Comments: I agree that this textbook was the definitive book back in 1996. However, the summary of research from 42 PDE experts was certainly more comprehensive than the 2 authors from the Goodman and Gilman article which you have used as a reference source. Purchase the book, it is an excellent reference source on PDEs prior to 1997. BigKNY3

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