I am obligated to limit my comments somewhat because it is my policy to not post information regarding possible changes in recommendations until that information has been disseminated to subscribers, for obvious reasons. However, I am obviously watching these developments very closely:
The problem is with both safety and efficacy. It does not appear that there were some dramatic, high profile adverse effects (e.g. mortality) that in themselves would have halted the trial, because that is where the Safety Board is supposed to step in. It appears to me that there was a sufficiently high number of lesser but still adverse events IN PROPORTION TO whatever efficacy trends were found (or lack thereof), that BI wants to see if it makes sense to continue the trial (which they are paying for and running). The one CNSI staff member privy to the unveiled data reportedly agreed with BI's decision. In other words, no one expected statistically significant positive findings this early, but even if there were positive trends at 7 days out, there is doubt as to whether they outweigh the negatives seen. We will not know for four months whether this is due to dosing, anomalies in the patient population, some other factor that can be worked around, treatment effects not measurable until more time has passed post-TBI, or instead reflects the same barrier that has knocked down every other NMDA antagonist thus far.
This does not necessarily predict problems in TBI, where the patient population is modally much younger, and side effects more acceptable given the context of multiple injuries (e.g. no one care if a comatose patient is hallucinating, or would have been if conscious.)
The next issue of NeuroInvestment goes out July 3, which means I will not be able to comment in detail regarding recommendations until July 10 or so. I hope this limited comment is useful. NeuroInvestment |
