Replies to post #41377 on Biotech Values

[fid]

You really need to do some more research before you respond.

1. From the Phase II 900 patient trial can you please explain how many patients would have had a peak CK-MB greater than or equal to 100ng/ml to put it in proper perspective and show why the failure of the primary endpt of 50ng/ml is significant?

2. From the current 3000 patient trial, how many patients would you expect to have a peak CK-MB greater than or equal to 100ng/ml?

From a former shareholder who sold on the failed Phase II results.

fid

[iwfal]

So in the group with a higher CK-MB levels it would seem that MC-1 provided a significant cardioprotective benefit. This is the study group used for the Phase III trial.

In the MEND CABG II study PR and Trial Description they do not actually say that they will be using as the definition of MI a peak CK-MB level greater than 100. Not knowing anything about this particular metric I'd still be surprised if the FDA allowed this definition of MI.

The reason is that too many times it turns out that the metric is only correlated to the true measure, but not directly coupled or directly causitive. FWIW with two positive trials for peak CK-MB I'd say (very preliminarily) that it looks like the drug does effect CK-MB in some way - but the evidence for it preventing traditional MIs is substantially weaker with only the one trial. Intriguing? Yes. but ... .

[fid]

"The Phase II trial FAILED."
The Phase II did not fail.

- The 250 mg dose of MC-1 had a 14.0% reduction in the primary endpoint composite of death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 50ng/ml), and non-fatal stroke versus placebo (p equals 0.312).


"The Phase II trial showed no change in MORTALITY."
A drug is not going to improve on some mechanical problems.

Your an anestheist, yah okay.

"The current trial will likely also show no benefit in MORTALITY."
The current trial is not designed to show a mortality benefit.

Happy investing