Biotech Values

[drbio45]

First we should call the company and try to verify exactly how MI will be measured and how that corresponds to the data from P2. Trying to raise 20 mil for the P3 trial they actually raised 25 mil. Some institutions believe.


Call the company and validate the ck-mb measurement. It is what you think. You have some people on the board that are making you doubt yourself so you should validate it and become more comfortable. The paragraph below is from the press release about recieving the spa. Why would they release peak CK-MB greater than or equal to 100ng/mlif it wasn't the endpoint in the trial. When they say the entry criteria closely follow the phase 2 it is mainly because the trial will only have the 250ml dose, the trial will be larger and stroke will be treated as an adverse event but not part of the primary endpoint. All these changes increase the chance of reaching statistical significance in the phase 3.

The study protocol and entry criteria for MEND-CABG II closely follow that of the Phase II MEND-CABG study. MEND-CABG was a Phase II study involving 901 patients that evaluated MC-1 versus placebo in patients undergoing CABG surgery. The 250 mg dose of MC-1 had a 37.2% reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml), and non-fatal stroke versus placebo (p equals 0.028). The reduction in the composite endpoint was driven by a significant 46.9% decrease in the incidence of non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml) with the 250 mg dose of MC-1 versus placebo (p equals 0.008).

enough said