Friday, March 21, 2014 12:25:11 PM
Afford,
They are in fact the judge and jury. They are the sole reviewers of the clinical data up to this point. While they have no real power to force the trial one way or the other, their recommendation carries serious weight. NWBO developed and agreed at the beginning to a set of guidelines for how the data will be interpreted and also to the actions that will be taken based on the data. And as for the timeline, Linda herself set that when she indicated the normal time for these kinds of reviews. I think history would support clinical reviews in line with what Linda indicated. This is outside of a normal time for review.
"Remember if they take too little time they are viewed as a rubber stamp and assumed to be inept if the drug fails/causes damage and if they take their time with such a new fangled drug it can only be on their side if just from appearance sake."
This process is not an opinion, it is a guided review of the data that either meets the threshold for an efficacy stop, meets the criteria for stopping for futility or is in line with the expected results and should meet the endpoint. Nobody is asking these members for their "gut feeling". The data are black and white or they are grey. If they are grey then the trial design is at risk.
Lastly, I don't believe that what the DMC recommends for the trial has to be released immediately. It is their recommendation and NWBO has the right and obligation to shareholders to verify and confirm before taking any action that might benefit or harm. And yes, I've dealt with the government more than you know. They have nothing to do with and want nothing to do with news getting out, bad, good or otherwise.
I'm not saying the delay is good or bad, I am saying I am losing faith that this is being handled professionally.
They are in fact the judge and jury. They are the sole reviewers of the clinical data up to this point. While they have no real power to force the trial one way or the other, their recommendation carries serious weight. NWBO developed and agreed at the beginning to a set of guidelines for how the data will be interpreted and also to the actions that will be taken based on the data. And as for the timeline, Linda herself set that when she indicated the normal time for these kinds of reviews. I think history would support clinical reviews in line with what Linda indicated. This is outside of a normal time for review.
"Remember if they take too little time they are viewed as a rubber stamp and assumed to be inept if the drug fails/causes damage and if they take their time with such a new fangled drug it can only be on their side if just from appearance sake."
This process is not an opinion, it is a guided review of the data that either meets the threshold for an efficacy stop, meets the criteria for stopping for futility or is in line with the expected results and should meet the endpoint. Nobody is asking these members for their "gut feeling". The data are black and white or they are grey. If they are grey then the trial design is at risk.
Lastly, I don't believe that what the DMC recommends for the trial has to be released immediately. It is their recommendation and NWBO has the right and obligation to shareholders to verify and confirm before taking any action that might benefit or harm. And yes, I've dealt with the government more than you know. They have nothing to do with and want nothing to do with news getting out, bad, good or otherwise.
I'm not saying the delay is good or bad, I am saying I am losing faith that this is being handled professionally.
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