Hi All !! Sorry I've been away so long, but I've
been under "gag orders". Now, for
clarification....
1. 40 vs 17 % is well above FDA approvable
numbers. Impotency drugs have a historically high
placebo.
2. 40% success was attained with the highest
average age of all trials, 59 years. Since the
older the subject, the lower the success rate, that
number is even MORE impressive.
3. The Second grouping of the Phase III may indeed
change the numbers, better or worse. One would
believe, however, that in an accurately controlled
trial (the Pval of less than .001 shows that fact),
these numbers shouldn't change much.
4. When a Company changes their clinical
endpoints, there MAY be cause for alarm. In this
case, however, the endpoint was changed to
accomodate the FDA. For the laymen, just try to
image how hard it is to get Governmet approval
after ignoring their less-than-subtle suggestions.
Translation: DO WHAT THE FDA SAYS, OR, NOMATTER HOW
GOOD YOUR DRUG IS, IT AIN'T SELLING.
5. Why all this comparison to VIVUS ? Let's face
it, If ZONA has a lower success rate than VVUS,
which it does, wouldn't you STILL rather try the
pill before you go shoving pellets down your
willie??? (remember the KISS theory: KEEP IT
SIMPLE, STUPID!)
6. ZONA GAVE NO FOLLOW-UP DATA The stock deserves
to fall !! But, unless the IMPORTANT numbers are
way off (ie 40 vs 17%), the follow up data will
validate the endpoints. Guess what happens?? The
stock goes WAY OVER 24 1/4.
7. TOXICITY: 1 adverse event in an abuse situation
is usually ignored by the FDA, especially when it
doesn't cause permanent harm.
8. VIAGRA: Is the PFE drug better??? Show me the
data!!! (if any of you DARE to show me stale,
year-old Phase II data should have your chat-room
privileges taken away!!!) I hear it ain't all its
cracked-up to be.
Well I'm sure I have more I meant to say, but the
bottom line is this: The stock will be choppy for
the next couple or weeks, until the validated data
is out. But, any of you who listen to Steve Shobin,
or Walay-I-Think-VVUS-Is-Worth-$100-Bucks-A-Share-
Because-I-Like-Shoving-Things-In-My-Schlong-Fayeme
(I bet I spelled his name wrong, and I don't
care!!) or Elliot, his salesman parrot, should have
hs head examined, and I don't mean the impotent
one!!! BUY and HOLD!!!!! |
