Thank you Flipper for this clear presentation of the sequential steps.
Everything is clear except #6. Are you hinting that RA's (especially thinking of NICE) will not be satisfied with a minimum of 48 months post surgery data? I understand that the UK is especially interested in long term survival data and QALY but how much beyond 48 months could that be?
Thanks for your perspective Flipper. Its amazing how you can open up so many nuances and truths about this trial. You have taught me quite a bit. That post was very logical! Thanks
Please exchange this with current gold sticky. (Or just delete the old one.)
As of April 2019, the image below is no longer seulement pour supplemental drugs and biologicals.
1. Cognate is GMP approved for their Memphis plant in Europe and the UK.
2. Cognate has labored for years to get to the point of readiness for a commercial rollout.
3. The (somewhere between) six to nine month SAP draft was, according to Dr. Bosch, the most labor intensive part of the road to unblinding. It was completed and presented to regulators before October 1, 2019 -- perhaps as early as July. It has not been submitted, because that occurs after topline. IMO It is important to understand the difference between presented and submitted, for which I only (unintentionally) added confusion in the prior unedited version of this post.
4. Dr. Liau explained why they went beyond the normal stopping points for the primary endpoint. It both hurts to hear, knowing the silence that was kept for years, but it is also encouraging in that Dr. Liau continues to state DCVax-l can manifest, in some cases, long term survival (along with progression free survival) with early treatment intervention.
5. A PFS reassessment was conducted at the end of the trial in November 2018.
6. The data collection validation was, continued, imho, so that it could at least validate until four years past the last patients surgery. They have now gone further beyond four years past last patient's enrollment.Essentially, they stated in their most recent 10Q that they have returned to consulting with the SAB about when to end the trial. This is disappointing, as it seems to be contrary to the steps to data lock precisely laid out by Dr. Bosch back in June 2019.
7. Amarin is more important as it relates to NWBO. Amarin has a blockbuster "drug" with a product that is simply manufactured better, but still natural. Dr. Cobb once said there are treatments, like aspirin, out there for certain kinds of cancer, but they are not studied because the they have no potential profit associated with them. I believe that the FDA is looking back through natural alternatives with an eye toward reaping the benefits for corporate America whilst using things that are more effective and usually with far less side effects. In short, I think the regulators and the market are ready for DCVax-L if efficacy can be shown.
8. In hindsight, I believe all the personnel (inside and outside NWBO) involved in seeing DCVax-L through, passed the delay baton to one another to ensure DCVax-L's potential was not lost through premature unblinding. Obviously I was not in on what I perceive was a conscious attempt to wring out all the efficacy for this trial. I also believe regulators want this, because they need proof of long term survival to get this over the finish line. I can't stress enough what it would mean to a patient in their Docor's office being told they essentially have no chance to live five years* , versus being told they have a 25% chance to live more than five years and a 19% chance for CURE -- "Like Brad." imho.
(* KM adjusted, but eventually after unblinded follow up, real time follow up to five years. imo.)
9. July 17, 2019 (and every year thereafter) marks GBM awareness day which was just enacted by Washington DC. Their primary reason for this legislation was to recognize the urgent need for a CURE.
10. For several years the river of time flowed to the sea whilst everyone waited, but the river might bring life to an ecosystem desperately in need. I pray for patients that it was worth the wait and abeyance from other research. I'm saddened for patients that NWBO may be trying to add further delay beyond what is necessary.
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