I trust you mean regarding the current Cerestat situation and 1997 prospects, not an overview of the Company as a whole. Now that subscribers should all have received July 97, I can note a few thoughts about CNSI:
1) the next critical time will be around the end of September, when interim TBI data will be announced. Since this will be 3 month followup data, it will be more telling than the 7 day followup for stroke. Since TBI patients are younger and better able to tolerate side effects of what is a higher dose level of Cerestat( and thus more likely effective), I am optimistic that this will be positive. However, unless CNSI decides it needs to disclose far more info because of the cloud over the company, we may not hear much beyond 'the trial is continuing.' Since people will still be hanging on for the Nov/Dec full unveiling of the 600 patient data in the stroke trial, I am not sure the stock will get a big bump out of TBI data(unless it is dramatic and discussed in detail).
2) Even if the full assessment of stroke patients already in the study shows that the worries about efficacy/safety tradeoff are unfounded, due to either a sample skew or dosing issue, the likelihood that this partial sample will be an adequate 1 trial for NDA is virtually zero. Thus for stroke, CNSI would have to run another full scale Phase III, requiring at best, another 18-24 months. And for stroke, that is the best-case scenario. Worst-case is having to abandon the indication entirely.
3) The net effect is to predicate CNSI's nearterm prospects all on TBI, and if the news is modestly positive, even if the stroke trial fails, CNSI could recover to 8 by year-end. However, since the amount of data on TBI to be made public is not clear, and the stroke problems might have a negative halo effect, I have placed CNSI on HOLD in terms of the NeuroInvestment Recommended List. This is not a sell signal, if one has ridden it down, one might as well hope to ride it up again. It is too risky at this time to be recommended as a buy.
That is the synopsis, hope it is of interest. NeuroInvestment |
