Peter, I agree that the MRI data could well be accepted as evidence of efficacy. But, the FDA would demand evidence of efficacy in the primary endpoints of the study and in direct symptom relief. The MRI data, although supportive, just would not be sufficient.
In regard to the subgroup analysis, you are again right. I made my comment in haste, before I realized that they were referring to the pre-defined sub-groups. The evidence is much stronger when prospectively defined groupings produce significant differences. However keep in mind that AIMM did not say that the results were significant.
Once again I agree with your spin. AIMM desperately needs some convincing positive results. The MRI data might provide that. But, they need to be presented in detail and statistical significance must be present. If they do this, then the results coulld indeed support the oral tolerance technology.
In terms of positives, I'm now looking at the AI 401 Phase II trials being run by Lilly. Lilly began a double blind, placebo controlled, safety and efficacy study of oral tolerance for the prevention of type I diabetes. The study was for one year This trial began in May of 1996. So, depending on the rapidity of patient accrual. The study may well be completed by now. I haven't been able to find out any more. I'd appreciate hearing if other know more about it.
The positive here is that the collaborative agreement with Lilly specifies that Lilly can terminate at any time. The fact that they have not and in fact began another Phase II study in France in Jan. 1997 suggests that things may be going well. They were scheduled to start a third Phase II in Italy this year. But, I haven't heard anything further in this regard. AI 401 is also being used in an NIH sponsored diabetes prevention trial.
This program, may be the one to keep an eye on. If positive results are produced, I can envision AIMM going back into double digits.
John de C |
