David B. Q. - Variability of insulin dose: Why would they initially try to control for it?
A. - They could have found a decrease use in the pramlintide group and they did not, this would have been a positive if the opposite was true.
They did find that within the type II pramlintide group, a subgroup of poor glucose control and stable insulin did better. And this is a positive, but it seems they want more data, so the ongoing study are modified to provide this.
Achievement of better HbA1c in the control group due to increase insulin group is not a pro for the placebo patient (not in pramlintide) at least the patients in pramlintide has less variability, even if not a decreasein insulin use.
They did say how they are going to improve the ongoing studies:
1. increase numbers of patiens per group, this is a simple way of getting good results. It is more expensive and it takes longer due to recruitment.
2. stratification, patients with poor glucose control to begin with, this is sicker patients. It is easier to demonstrate an effect in sicker patients (unless they are dying, then it is very difficult like in lipo sepsis pts) but this are chronic patient, not dying ones. Again more patients, and more time, more money.
3. Maybe they did try to get a quick shot (and a less expensive one)with the actual design, but it is not a clearcut answer and they did find that.
4. This company provided an honest report, and they are genuinely looking for an answer. There are other biotechs that do not give you even the impresion of honesty.
Short term: this is at the best a non moving stock, like ALLP,REGN until new reports of ongoing studies (my quick guess 6 to 12 month)
Anybody looking for a quick buck will be dissapointed here. At worst, this could be like Xoma in the early 90s great company, great research, a somewhat dissapointing but not hopelessly report and a long slow going down another 50% will follow. |
