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Biotech / Medical : Vivus: into single digits -- Ignore unavailable to you. Want to Upgrade?


To: MissLil who wrote (59)2/8/1998 9:23:00 PM
From: BigKNY3  Respond to of 1016
 
Miss Lil: << As I believe you are an M.D., it may be obvious to you that this is a select group, however, I doubt that it is obvious to the majority of investors. To those who are not M.D.s just think about it, does it seem logical that an oral drug would work in as great a percentage of patients as those who INJECT the drug, thereby getting a greater concentration in the region of interest? >>

Miss Lil: First of all, I am not a physician but an investor in Pharma stocks for over 20 years including PFE, MRK, LLY, WLA, AMGN, and VVUS.

Right now the Viagra Phase II and Phase III clinicals are being reviewed by the FDA. From a PFE investor standpoint, that's exactly where you would want this analysis to be.

From physicians' standpoints, there is not enough published information available to make a determination about the future role of Viagra in their practices....now. However, prior to market launch, there will be plenty of articles and data for healthcare professionals to evaluate from respected leaders in the field of ED... many of whom have also evaluated MUSE.

I also agree with you that only with extensive usage of Viagra upon approval will its true efficacy and safety profile be determined. This is the primary reason why the FDA requires post-marketing surveillance on almost every new product that they approve.

Again, I appreciate your honest response and wish you success with your investments!

BigKNY3



To: MissLil who wrote (59)2/8/1998 9:33:00 PM
From: Tunica Albuginea  Respond to of 1016
 
Excellent post again Miss Lil, which obligates me (against my better judgement) to respond to you in this thread! gg. However the purpose of " The SI Threads " gg is hopefully to help investors, each other, to make better investment decisions. My points:
-For your info, Big KNY3 has an MBA and is not a physician (by his own introduction to this thread)
-He sounds like a physician because he has invested in drug stocks for many years and successfully so. [I would add that that would not have been a hard thing to do because drugs have consistently done well
The last 17 years or so, thanks to " no questions asked " policy of our health care system the last 20 years. This is now changing and IMHO
ANY drug investment is suspicious, if you stray too much from investment fundies: Merck is OK Drug companies with PEs in the 40s are not (IMHO)} Having gotten that off my chest let me also mention that Big K has 2 sisters who are both physicians and with whom (I assume) checks his data.
-Having said that, we come back to the data.
-Everything you've said is 100%.
-Also, the classification of PDEs that Big K has used indicating that retina has PDE VI ( as opposed to penis which has PDE V) is only partially true. The complete facts are:
=First of all the classification he posted 2 posts before,
is Nicholson's classification of 1991. By now that is antiquated
=We now know that several organs have multiple PDE systems; the
retina also has PDE V.
=he is missing the point again on PDE selectivity: The
selectivity IS VERY NARROW. Meaning that the RANGE of drug DOSE
between when the drug is selective and that of the higher dose
where it is NO longer selective is VERY NARROW.That means that
if the drug is not effective at 50 or 100 mg, you will not be
able to increase it to 200 mg to get an effect. Motrin for
example you can go from 200 mg to as high as 800 mg in a single
dose.
=the corollary to that of course is that what in pharmacology is
called " the toxic therapeutic ratio ", is very narrow for these
drugs. And you and I know how dangerous that is with similar
tight ratio drugs like Digitalis for example.
= it is remarkable to me how the " blue halo " effect of Viagra is so easily dismissed.
If one were to open any ophthalmology book and read how in the most common
Cause of blindndness in the USA ( macular degeneneration) there is an increased
amount of cyclic GMP in the retina , one ought to be very concerned because that is exactly what
Viagra does : increase cGMP in the penis. Nobody has gone so far and measured cyclic GMP in ]
The retina gg. I guess that will be in phase IV after the drug is out in Th emarket when people will
Start noticing increased visits ot the ophthalmologist when you are on Viagra with your vision going
south. But hell so what. We had the same phase IV scenario in Redux and we are all still here;( well
almost all ).

Other considerations that Big K brought up of course are of no consequence: The Vivus AD warning signal for Sickle Disease is because they want to make their drug warning idiot proof. Sort of like the ones on guns: " don't shoot this unless you've read the manual". Or "don't dive in an empty swimming pool". First of all the people with sickle cell disease taking Vivus/MUSE is exceedingly small. Secondly the docs need to know about this before prescribing it and it is clearly spelled out in the package info. I guess they are worried that a) a doc isn't going to read the instructions and/or b) somebody is going to use surreptitiously his grandpa's MUSE and get into trouble. When you've been through a couple of lawsuits your outlook changes.Thirdly the pain is not that big of a problem: I will post a recent article in Urology were this sensation was felt to be of no consequence during intercourse.It was covered by the pleasure sensation.

TA