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 five month SAP draft was the most labor intensive part of the road to unblinding. It is complete and submitted to regulators -- in my opinion.
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.
6. The data collection validation was, continued, imho, so that it could at least validate until four years past the last patients surgery. That occurs in one month. Essentially they are leaving it in the hands of regulators as to whether or not to drag this past September. I don't believe regulators are their enemy at this time.
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."
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.