A couple more TBI questions -
1) In the TBI Phase 2, during the initial 3 months, Dex provided a much more rapid rate of neurological recovery than placebo, but then the drug's benefit appears to trail off as they approach 6 months. Even at 6 months however, the Dex arm still showed an advantage in neurological recovery of 47% vrs 32.4% for placebo (which would represent a 45% improvement over the placebo arm). Wouldn't a similar 6 month result in the larger 860 patient Phase 3 easily be considered statistically significant?
2) In the published Phase 2 results, they also break down neurological recovery based on the patient's GCS scores upon entry into the trial. At 6 months, the GCS 4-6 patients did phenomenally better than placebo, while the less seriously injured GCS 7-8 patients beat placebo, but a lot less dramatically. Let's say the Phase 3 has similar results, but the GCS 4-6 subgroup reaches statistical significance while the GCS 7-8 subgroup doesn't (and the combined GSC 4-8 group just misses). Is it possible that the FDA might still approve Dex, but with a label limiting its use to GCS 4-6 patients?
3) With the tapering off of measurable drug effect by 6 months, the suspicion might be that there may be only a very negligible drug effect by 9 or 12 months. Suspecting this, might the FDA want to see additional data going out a year? |
