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Re: AVII77 post# 56009

Sunday, 03/06/2016 12:05:47 AM

Sunday, March 06, 2016 12:05:47 AM

Post# of 693135
AVII77,

You stated "The primary ethical reason would be that the consent form is no longer valid." This may be true but why would you not mention that, if accounted for separately, mesenchymal GBM consideration might be causing some consternation with regulators ethically speaking. I know this discussion has come up before but I can not see regulators finding an easy way around this issue. Their PRIMARY purpose is to work for the best interests of the patients and is the reason for their existence in the first place. I believe they would have trouble ethically if they didn't do something positive for patients if, after a look at data that shows a clear benefit for a pre-planned treatment subgroup, crossover does not help this group as well. I believe this screening hold was initiated by NWBO and may be designed to offer them the option you and others have discussed but also create the opportunity for an ethical dilema. I have stated there might be an ethical dilema challenge before on SA. Linda does like "multiple shots on goal". Your thoughts?
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