NWBO has been 100% silent on the issue since the "draft complete" in the 10-Q. And there is no legal requirement to disclose.
Many longs infer that it must be complete else LP would not have given schedule based on other steps in the process. Some "shorts" would suspect that if LP keeps something quite it is not good news.
There is also a reasonable middle ground. They might have an "acceptable" SAP but not their "ideal" SAP. In that case they could still be trying to work the issue, but if that fails they would go with what they have and unblind per schedule.
Reg, yes LL said the original SAP is no good because we know it was based on obsolete chemo trial design that looks for progression as evidence to assess the efficacy which can be decided within a short period of time. We know now the design for immunotherapy trial has to include the tail that involves non proportional analysis of K-M curves where the trial prolongs to capture robust OS endpoint a must. So, LP et al developed an updated SAP and sure flashed back and forth with the RAs but it doesn't require RA approval but definitely their blessings after changes if any are made. Thus a Statistical Analysis Plan (SAP) will give more detailed descriptions of the endpoints in the study and the corresponding analyses and it is a document of the trial sponsor that is developed and held by the sponsor and when the trial is unblinded, this SAP that was keyed in into the Computer analyses the unblinded data spit out the results. It does not require FDA approval beforehand, after, or any timeframe in between. See one for example how the document flows.
So in our modified one, I bet comparison of endpoints with historical control is included as one option for FDA approval. We know FDA has put out a guidance document unprecedented in its history that proposes that sponsors can compare their trial results with historical control in certain circumstances. One thing you should note is that this guidance document was rushed out by FDA after they looked at our modified SAP. This tells me that FDA is on our side. Just sit tight and everything is going to be alright relatively sooner than you and I might have anticipated upon. I think LP is going to move forward stick to her timeline of May Data Lock and July TLD even if the final guidance is not out due to Corona issues taking up the FDA time, still FDA already proposed to accept historical control anyway. Best Wishes!
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