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Re: Dressed up FUD."I pointed out (as you had previously) that the FDA had given their seal of approval to this becoming a P3, and simply stated (in response to Hodag) that if they received an RTF for the reason that they failed to conduct a confirmatory trial it would render the original green light as pretty meaningless." First, nominally calling a trial a phase 3 trial is not the same as agreeing that a trial is potentially pivotal. Second, approving an amendment is not a SPA. Third, your statement leaves no room for the current trial being identified as less than adequate for any number of reasons and therefore not meeting sufficient approval criteria as a standalone result. It assumes that any result the company is willing to submit is should be accepted because the FDA agreed in the past that it can nominally be identified as a phase three trial. "I did say that I got the impression that the company thought it was an issue that would be resolved much quicker than it was." So the issue was resolved? Interesting that Cel-Sci's partial hold was similarly resolved and yet neither company resumed enrolment. "This P3 trial has not stretched out over a decade." From clinical trials.gov
Look at the blended OS KM curve and count the tick marks that fall at a time frame less than time-on-trial for last patient enrolled. "Not as much as you are already rehearsing where you are going to place the blame!!" Many discrepancies are already apparent and do not require topline or detailed results to be identified. I fully expect the announcement of the results to be unclear and misleading. |
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Msg # | Subject | Author | Recs | Date Posted |
13416 | Re: Dressed up FUD. | erniewerner | 0 | 8/19/2019 10:31:11 AM |
13418 | Re: Dressed up FUD. | longfellow95 | 0 | 8/19/2019 4:04:18 PM |