foxhound02,
Right so the process is Dr Linda Liau and others put the journal article together, NWBO reviews and checks off concerns and adds any comments about wording. Potential second draft gets put together then seen by NWBO again for further comments/approvals. In this process FDA guidance and opinion are taken into consideration and opinion about timing for submission gets discussed because endpoint analysis and validity of that analysis will be part of drawing any conclusions made about treatment effect in the article and must pass peer review, regulators actually being part of that group, as an informal prerequisite for formal approval by regulators such as FDA.
In the mean time, manufacturing issues are being dealt with so that positive data can be translated into a rapidly and widely available product soon after if not before actual formal approval which of course is supposed to be considered as kind of detached in significance from the journal article but in this case is very likely quite closely tied to it in several ways, especially as regards passing through a thorough peer review of a novel treatment approach in GBM but with platform implications for all solid tumor indications. Kind of a big deal where you want all the independent and semi independent moving parts to line up or you can pay a steep price.
If there is going to be a leak then it will come when the journal article gets submitted for review to the publisher or when info gets uploaded as to publishing date but I would suppose it’s “hackers and friends and family of reviewers beware”. I suspect trades in NWBO are being tracked very carefully right now. Now wouldn’t it be cool if those trades could be played back in slow motion?; ). Best wishes.
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