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To: Cal Gary who wrote (6958)3/18/2001 1:36:26 PM
From: Joe Krupa  Read Replies (1) | Respond to of 14101
 
Cal Gary et al.,

On a couple issues, I had a different read from the Rob-TV interview, than most.

Overall, I would say we are closer to the US market than would appear from the interview. I really think there was an obvious attempt by Rebecca to divert attention away from the FDA issue. Here's why:

In regard to the question on J&J, Rebecca responded that the "agreement proscribes" them from discussing the details of that agreement. What agreement? The standstill expired long ago, which left no agreement in place to "proscribe" anyone from anything. I believe the word "proscribe" refers specifically to a written agreement, and not to any sort of verbal understanding between the two negotiating parties -- the root word of "proscribe" is "scribe," or to write.

Notice the change of language here. In the past, this issue was always explained away by Rebecca as, "it's not in the interest of the company or shareholders to negotiate in public." In other words, in the past, this was a strategic decision -- now suddenly it is "proscribed." I read into this that the deal is likely done, as many other clues lately have pointed at.

Now, on to the next question about the FDA. Rebecca mentioned that a plant inspection is not scheduled yet, but are "looking forward to it." This is way more than Rebecca has ever been willing to offer in the past in regard to the progress of the FDA filing. So, the first thing she ever says about FDA is that they are looking forward to a plant inspection. In other words, they are looking forward to the last step before being approved.

Seems to me that, by bringing up the words "not scheduled yet," there is a deliberate attempt to say that there is reason to believe that it will be scheduled shortly. I look at this as being analogous to two people volunteering that they have not scheduled a wedding date yet, but are looking forward to doing that -- you don't talk about scheduling a wedding date if you don't plan on getting married or the relationship is not going very well.

Perhaps I'm reading more into this than is actually there, but taken in the context of all the other clues that I think Rebecca has provided lately, I don't think I am.

joe



To: Cal Gary who wrote (6958)3/18/2001 3:03:38 PM
From: Joe Krupa  Read Replies (1) | Respond to of 14101
 
Cal Gary,

Below, I have pasted a copy of a post on SH by Beckysboss, in which he replies to your last posting. He asked me to provide a link here in case you did not see it on SH.

Good stuff from both of you!

joe

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
stockhouse.com

Calgary from SI said ,"Based on another recent SI post, the additional Celebrex studies for the recent proposed label changes appears to be tainted. Upwards of 25% of people rejected for inclusion in the study, then 10% of study population suffers side effects. I take this as an opinion and not fact at this time until a publish document can be produced and posted. But Ilike it!}"

I don't post on SI but I noticed this question regarding the FDA info I dug out a week or so ago. This is a valid question and worth clarifying. Firstly, the 25% number Cal Gary refers to is a interpretation error. Everyone included in these studies must pass a screening for symptoms of GI problems etc. Don't know how many didn't get included or didn't pass this screening. What it means is that everyone who started this study didn't have previous symptoms or pre-existing conditions. The drop out rate is from those that passed this test first. You need to see it to believe it, I do anyways. Since this has a huge impact on this stock as we roll out I thought it worth posting the exact site and details so that you can look at this information. Becky in her interview said that 10% of the market cannot tolerate NSAIDS, that is great news, it means a huge market. However Becky is being coy according to the numbers from our competitors. It is more like 20->30% suffer pain and adverse events that force them to discontinue taking Celebrex or Vioxx. At 10% the market is approx. $1.25 billion give or take a few hundred million. Now move that number in line with the Celebrex/Vioxx studies at a multiple of 2 or 3 and wow, it does make you smile Wily!

Celebrex Study

fda.gov

open "briefing information" - PDF document - on page 46

- chart indicates 22.4% of patients in this study had to withdraw due to adverse events(adbominal pain, dyspepsia, etc..)

Vioxx Study

fda.gov

Open "Statistical Review "- PDF document - on page 11

-chart indicates 29.81 % (total the column under rates) of patients in this study had to withdraw from the study due to adverse events (primarily serious clinical AE's ie.GI bleeding and/or abdominal pain)

I appreciate Cal Gary bringing this up, we have a tendency not to believe everything we read on a bulletin board. This information is extremely important to all of us as shareholders, in time we will see its impact on sales and ultimately the bottom line, share price.

W