Results from third cohort may even improve Phase II preliminary results.
We know, for instance, that 3 of 30 people died in the HU-211 -treated portions of the first two cohorts. Since there were two HU-211 groups, one given a 48 mg dosage and the other a 100 mg. dosage, some kind of trend also exists within the dosage levels --
Possibilities:
1) 48 mg. 3 deaths
100 mg. 0 deaths
2) 48 mg. 2 deaths
100 mg. 1 death
3) 48 mg. 1 death
100 mg. 2 deaths
4) 48 mg. 0 deaths
100 mg. 3 deaths.
My "guess" is that the second is correct, although the first would be super. I'm hoping we end up seeing improved mortality in the third cohort.
Obviously we need a Phase III study to definitively answer the questions that the second phase opens up. What we know for sure at this point is that HU-211 is safe, without serious side effects that have plagued other drugs for this problem, and that severely injured patients do make improvement. And, of course, the information about reduction of intracranial pressure without accompanying drop in blood pressure. Dr. Fernandez' comments about the applicability of such a drug to various forms of brain surgery are very hopeful in that they suggest a significant enlargement to our potential market.
Congratulations are due to PARS management. They have also made significant progress in the way they handle PR for the company. Very professional job this time. Shows management skills are growing, improving, too.
-Ariella |
