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To: axial who wrote (11275)10/24/2002 10:35:27 PM
From: Montana Wildhack  Read Replies (1) | Respond to of 14101
 
Jim,

I also agree with BJ.

From furnitureman's notes:

* "FDA submission is complete....Nothing else is required at the moment"

* Some discussions are taking place about US labelling

* Marketing Study in Canada (oral NSAIDS vs Pennsaid) was "completed at the end of Sept". "We're confident of the results" i.e that they will continue to show effigacy and safety. DMX wants results published in a journal of some kind, and to ensure that a journal will publish the results she will not pre-release before that.

There they are folks right in a row in his notes and those
are the three pieces we need to know what's going on with
the FDA. (BTW I validate the accuracy of these quotes)

Realize -
The US is advertising/marketing driven
The studies were conducted formally
The key question EVERYONE will ask is "how is it compared
to Celebreaks and Viaduck"
Pennsaid is more concentrated at the location than systemic
delivery
Pennsaid enters the bloodstream in only trace amounts so
side effects are unlikely
A percentage of patients in double blinds using placebo
get some serious ailments (look this up its a riot)

I'll just say it.

My suspicion is that Pennsaid will benefit from these trials
in its ability to get better labelling and make more
direct statements in both advertising and marketing. The
trials being conducted by Dimethaid add real value to the
ability of any major pharma (the US will be a major and its
JNJ) to be successful while making a Pennsaid deal more
valuable.

JNJ is in all three treatment segments but in none with an
NSAID and frankly Tylenol3 with codeine already owns its
high end niche with no ability to cut into the NSAIDS -
unless they had PenNSAID with solid head to heads.

I have stopped watching for an NR for right now and am
looking up herpes/shingles/and this class of ailments which
knowledgable people were kind enough to clue me into
regarding Pennsaid.

Wolf



To: axial who wrote (11275)10/24/2002 11:19:56 PM
From: Mark Bartlett  Read Replies (1) | Respond to of 14101
 
Jim,

<<Has IR finally learned not to make wildly optimistic forecasts and projections?>>

Interestingly, at the scrum there were a few people who asked the question "how long" for various things .... REK reminded these people that shareholders had told her to no longer make predictions about "when". That is all she had to say and the issue was dropped.

MB