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
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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 |
