Biotech Values

[mouton29]

Here is what Craig Wheeler said starting around 17:50 into the latest conference call:

We reached our primary endpoint, we will be presenting the data on the 24 at the transcatheter therapeutics conference in San Francisco. The top line data is very good, I urge you to take a look at the data releases that we will be doing. Its not just the top line that tells all here, ALL [clear emphasis] of the underlying indicators were favorable for this drug, you will be able to see that data at the conference coming up, and we will release it but we are very very enthusiastic about the potential for this based on this trial, where quite frankly we didn't expect to see as much as we did see because this is only a single infusion as opposed to the multiple infusions you will see in the ultimate ACS trial. So good news for us for establishing the concept of rational drug design.

He sounded more enthusiastic than he did on the August 6 conference call, though some of this may be explained by the fact that he only had 20 minutes and was speaking at warp speed at the more recent presentation. From the Seeking Alpha transcript:

The primary analysis in the study provided evidence of non-inferiority of the combined M118 group combining all three doses as compared to the unfractionated heparin group within the parameters the perceptively defined analysis. The observed incidence of the composite endpoint was lower in all M118 treatment groups than in the unfractionated heparin group. However, it should be noted that this is only a data trend; the study was not designed or powered to detect statistically significant differences between treatments. The incidence of serious and non-serious adverse events was comparable in all treatment groups.

We are encouraged by these results which support the proof principle that are rationally designed low molecular weight heparin could potentially address some of the limitations of currently available therapy.

We look forward to talking about the details of this trial when appropriate. However, it is our preference to release clinical data at appropriate scientific meetings or in peer review journals. As we discussed in the past, it is our intention to seek a partner for M118 to support our clinical and commercialization efforts following this trial.