NWBO is like SPPI in that they both have pivotal trials completed and both will fill an unmet need if approved. Differences though are SPPIs drug will address a smaller market (3300) whereas NWBO's DCVax-L will address a patient population 6x bigger (i.e. GBM 3.19/100000 or ~10,000) in the USA and another ~10,000 across the Pond (some speculate it might be approved there first). Additionally, DCVax, if successful, can become a platform drug for all solid tumors which is huge. However, unlike SPPI which has released topline data and submitted their NDA to the FDA, NWBO has data locked back in Oct 2020 and we are still waiting for Top Line Data. There are solid reasons why this is occurring (and as a long, I believe they are valid reasons but as one can imagine, the bears are having a field day with this). The one big thing that keeps longs so positive is release of a paper in 2018 analyzing the blinded data which includes combining the placebo patients and those who took the drug and the combined data kicked Standard of Care's azz. Of course, since it's blinded, a bear could argue that the placebo (SoC) patients are doing much better than one expects. A Long would argue that after 30 yrs, and to this day, a patient on SoC will only survive ~15 months so why would you expect placebo patients to all of a sudden have much better outcomes? There is so many more angles and nuances to this but to make a long story short, they are waiting for a top tier Journal to publish the data and TLD will coincide w that. Longs are expecting it could be released any time and way before ASCO 2022 but I think many will start bailing if it doesn’t happen by then. If you are interested, the IHUB NWBO has a quite extensive Introduction page but I hope this helps.
Let’s go SPPI!!! but where’s the NDA PR?
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