Maverick0408, I am a patient man, especially when I have invested in a biotech company that has had a very successful Phase III clinical trial, that met both its Primary and Secondary endpoints with clinical significance, and its treatment will help cancer patients worldwide.
I will always continue to monitor "the real facts on the ground", not baseless opinions on message boards or other social media platforms. to continually update and tweak my NWBO investment strategies and decisions on an ongoing basis. I will make whatever changes I need to make to my strategy based on the current facts as we move forward through time.
I was, and I am still hopeful that NWBio will use the FDA's Project Orbis program to be able to have almost simultaneous submissions of the DCVax-L BLA / MAA packages to all relevant Project Orbis participating countries (US, Canada, UK, Switzerland and Israel).
However, no one knows for sure, but maybe NWBio knows. Most on this board believe that the UK will approve DCVax-L first. For me, I still believe Project Orbis would be the fastest and most efficient pathway. But, as I have said before, I will not be too disappointed if the UK approves first, then the other countries (US, Canada, Germany and the rest of the EU) follow with approvals in short order.
I said that NWBio should focus on the ROW approvals after DCVax-L is approved in the US, Canada, UK, Germany and the rest of the EU. That is simply the natural order of how DCVax-L approvals should progress.
Also, I am like Dr. Liau, and Dr. Ashkan, I want DCVax-L available to treat all GBM patients worldwide. Also, I am like Dr. Pazdur, if there is a new safe and effective treatment, that extends overall survival (OS) for a large percentage of patients, and is an effective cure for some patients, then that new treatment should become the new global standard of care (SOC) for all future GBM clinical trials worldwide.
In my opinion, especially if NWBio has a significant large pharmaceutical partner, multiple concurrent clinical trials for both DCVax-L and DCVax Direct will be conducted at the same time, to obtain regulatory approvals to treat all or most solid tumor cancers, both operable and inoperable.
I believe all of these future DCVax trials will be completed much faster, and NWBio will have access to a lot more additional resources, including access to cash to fund these future trials.
