Replies to post #41573 on Biotech Values

[trade1]

drbio- I don't know what people expect MC-1 to provide, the reduced myocardial damage is a significant long term benefit. I doubt any cardioprotective drug will reduce the mortality rate within 30 days post CABG. If death occurs then it probably results from unusual stress during the post-operative recovery from infection, surgical technique, or a secondary disease process.

CABG's are performed to improve cardiac perfusion so you would not expect to see mortality from MI in the placebo or MC-1 groups. The heart should be in better condition after the surgery then pre-CABG so mortality should not be the primary clinical end-point.

All of us know this is a speculative investment, but the clinical results are impressive if looked on from an objective viewpoint.

[fid]

Last rant from someone who supposedly answers questions with questions and doesn't respond to evidence properly, keeps switching endpts and plays with numbers.

More numbers for you, Readers Digest(Feb 2007) edition had a few articles regarding issues surrounding the heart. In one article it stated that more 21,000 Canadians will undergo open heart surgery this year. Up to 5% may have minor heart damage during the procedure, another 1% have a stroke and 1-2% will die within 30 days of the operation, up to 400 Canadians.


can you specifically say why you believe the data wasn't remotely strong enough. In the 250ml trial they had a 37 percent reduction of non fatal mi death and stroke. In the 750ml dose they had a 31 percent reduction in non fatal mi, death, and stroke.

The 100ng/ml endpt is so far to the right that it renders the trial meaningless.

The Alexion trial was statistically significant at 30 days for MI and several other analysis but this had no effect on mortality.

http://www.biospace.com/news_story.aspx?StoryID=14315320&full=1

<<Day 30 in the overall Intent to Treat population (18% relative
reduction; placebo 12.0%, pexelizumab 9.8%; p=0.042)>>

Lets say for example that the Phase III MPH trial was successful and the results were the same as the Phase II. They were able to reduce CK-MB from 100ng/ml to 90ng/ml in a small number of patients. This would really have no outcome on mortality 30, 90 or even longer time frames.


The drug doesn't have to reduce death in 30 days to have a meaningful benefit. Reducing non fatal mi is all it needs to do. As long as it doesn't increase death, which it shouldn't.

Ive been around these boards for quite a while now and this is the first time that I have seen anyone on any board say that a component of the primary endpt in a pivotal trial is really a needless component. If reducing non fatal mi is all it needs to do, again check out the Alexion results, but put on your diaper first.

I previously owned MPH for about 2 years or so and sold on the failed Phase II results. Looking again at MPH, I believe that I made the right decision.

My bet based on not looking at the evidence properly according to some is this trial will fail.

My thoughts FWTW

fid