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Sunday, May 12, 2019 1:53:39 PM
Maybe that all SAP's filed and being reviewed? These only needed revision "A SAP also is prespecified before the start of a trial. It may be amended during the trial while the data are blinded but is finalized before the analysis is completed and the data are unblinded." NWBO has likely been working on revisions since ASCO18.
To me, if it is announced that all 4 SAP's have been submitted and approved, we have our first home run. Meaning that if regulators accept the amendments for reviewing data, we have probably addressed and convinced them that pseudo progression issues need to be readjudicated in our favor.
No matter what we need something at ASCO!!!
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