Thread by @biosectinvestor

$NWBO #DCVaxL With regard to Dr. Roger Stupp being a consultant at $NWBO as they move toward the reveal of their top line data for Phase 3, publication and application to the FDA for approval, the BLA, adding him to the team I think is quite significant.

I made these points with other investors, so am sharing here.

This is ALL IMHO, and I own shares in $NWBO:

Since the Stupp Protocol established the Standard of Care (“SOC”) for the industry, and NWBO needs a placebo arm that is consistent with the Standard of Care, Stupp, being the father of the Standard of Care, now joining to advise and consult not only makes sense, it is…

…extremely powerful in significiance in terms of establishing NWBO’s credibility with the FDA, for this trial, that the synthetic placebo arm they have created is appropriately and correctly constructed, most likely with the help, advice and guidance of Dr. Stupp himself.

It’s incredibly significant as we already have a good idea that the blinded data including the original placebo patients was (IMHO) outstanding.

The ONLY thing that was at all worrisome, maybe, was 1) that the FDA was really on board openly and probably on the external data approach (there are multiple, consistent and strong indications that that is the case and that it is in the direction the various agencies want to…

…head); and 2) that NWBO could construct that external data based synthetic placebo such that it was accurately consistent with what would be a meaningful and statistically relevant synthetic standard of care based upon the Stupp Protocol.

Now with Dr. Stupp likely literally advising on that part of an equation that MIGHT have seemed uncertain to some, it seems unlikely to me that that particular item would still be a significant worry.

In my mind that is game… now we are waiting on the TLD as the “set” and the regulators to call the “match”. But the case looks stronger and stronger every day! Again, just my personal opinion and judgment, and everyone should do their own due diligence.

More on the Stupp Protocol radiopaedia.org/articles/stupp…

Who better to create the synthetic placebo arm replicating the current standard of care for Glioblastoma than the original creator of the current standard of care, Dr. Roger Stupp? Should be very reassuring for the FDA.

$NWBO #DCVaxL