Replies to post #4583 on NorthWest Biotherapeutics Inc (NWBO)

[austinmediainc]

I personally think that is a very biased and irresponsible comment. I respect your opinion but that is all it is. At the end of the day we don't know if long or short is good or bad. Everyone here that has invested in bios knows anything can happen, good or bad at any time.

Also, the DMC reviews the data to make their recommendation, I don't believe any of that info is shared with the company or public.

Here is an interesting read for those who want more knowledge on the role of the DMC. I have included an excerpt below as well. GLTA

http://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm

4.4.1.1. Monitoring for Effectiveness
In studies with serious outcomes, all parties would wish that any major treatment advance be identified and made available as soon as possible. It is critical, however, that the study yield a valid and definitive result. Thus, tensions between ethical and scientific considerations may arise. Consider, for example, a placebo-controlled trial of a new product for a serious illness or condition for which there is no standard treatment. If the emerging data suggest that those receiving the treatment are doing better, one might expect that a DMC would consider whether the study should be terminated earlier than planned. Estimates of treatment effect, however, will be unstable at early points in a study, and the chance is substantial of observing a nominally statistically significant benefit (e.g., p<0.05) at one of multiple interim analyses during a study of an ineffective product (see Section 4.4.2). A DMC, guided by a pre-specified statistical monitoring plan acceptable to both the DMC and the study leadership, will generally be charged with recommending early termination on the basis of a positive result only when the data are truly compelling and the risk of a false positive conclusion is acceptably low.
A second type of consideration is whether the hypothesized benefit is likely ultimately to be achieved. If the interim data suggest that the new product is of no benefit—that is, there is no trend indicating superiority of the new product—or that accrual rates are too low or noncompliance too great to provide adequate power for identifying the specified benefit, a DMC may consider whether continuation of the study is futile and may recommend early termination on this basis. In this case, false negative conclusions are of concern; statistical procedures are available to guide such determinations (see Section 4.3.2).