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Re: Pyrrhonian post# 39709

Monday, 08/31/2015 4:43:41 PM

Monday, August 31, 2015 4:43:41 PM

Post# of 703805
"I am not ashamed to admit that I am of the opinion that a halt for efficacy is the most probable outcome of this trial, by far, and soon. Probably in less than two months, and possibly in less than one (according to my working theory)."

But it's okay with me if it takes longer because:

"using an "interim" look of a trial to begin the process (after it has been analyzed) to petition the FDA for accelerated approval happens, at the interim look (where we were not long ago). Of course, the results have to be tabulated, analyzed, and then the petition sent to the FDA, then discussions ensue, then the FDA deliberates, then delivers their decision = significant time lapse. The only good thing about this time lapse (and as per the quote above), is that the data that accumulates in the ongoing trial during this time (in our case, events 67-?), can actual BECOME the "post approval confirmatory trial" data normally required post AA. Thus, we may get an AA, and then full approval in quick succession."
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