exwannabe,
If Direct is "the same" as L in that it produces "the same" end product of a safely activated/matured DC, then approval of L is essentially "the same" as the approval of Direct. Why spend money on trials that only prove what you already know based on an SAP that highlights why an activated/matured DC product ends up producing the correct range of chemokines/cytokines necessary to produce an effective immune response? Besides this, we all know that NWBO is using all of their resources to finish up with L and that doing anything else would be touted as a distraction and signal that L was a failure even if NWBO came up with your $10,000,000 separate financing estimate.
A Direct patent claims that NWBO knows who will respond based on their ability to get DCs into the right range of chemokine/cytokines production levels. The reason this works is because these levels produce the right amount if pro inflammatory response in certain situations and other things can be added to improve upon this response when needed. I believe Germany helped NWBO do this better by adding their cell selection technology into the existing cell selection process without any additional step being taken to change the product other than purity, therefore, no new IND needed but more equal and purer DC aliquots created which is part of improving "the art" of manufacturing.
There is plenty of proof in the literature to affirm that what NWBO does is mimic what our body does when not compromised by interference signalling caused by cancer or other sources. This SAP will finally deal effectively with pseudoprogression/PFS and correlations to benefit from proper pro inflammatory factors. The exception rule to "adequate and well controlled trials" governance has been explained well enough by now so that you and everyone else should know that this is going to be one of the primary focuses of the revised SAP.
I believe that Merck and perhaps a German pharma have been given a better look at what NWBO does and does not need from them. Up until now NWBO and Dr. Linda Liau have been suggesting improved outcomes being possible for patients with a combo treatment of checkpoint with L. Notice that they have not trumpeted that there was no need for checkpoint inhibitors with Kat's Cure and probably not with Mr. Powers from Canada either. That should have sent a big chill down the back of those with checkpoint inhibitors. I think at least Merck understands what that might mean for them, cleared the backround check hurdle that Linda and Mr. Cofer Black would have set up and went in to learn more after Linda told them what she believes they have with the idea to partner if Merck comes to the same or very similar conclusion. These folks know how to have negotiations without having to disclose a thing because nothing formal or binding is being talked about. Just a "passing interest".
Now let's look at what Merck has to offer in the way of help in expanding the platform into other diseases. Merck has a great portfolio of monoclonal antibodies and other agents which can be used in the process of activating and maturing DCs for a particular purpose. Merck also has a bunch of top notch immunologists and researchers working for them and been building out their cell therapy manufacturing. Rapid expansion of this platform would be in the mutual interest and capability of a combined Merck and NWBO with some consideration given to the economic impact on others whereby certain agreements would potentially allow for carefully monitored subcontracting services.
This look at the big picture seems far fetched except when you know the possibilities by understanding the science. Only those who truly know this science and that NWBO, with Merck's help, might be trying to make a case with regulators for L being "the same" as Direct can possibly fathom the value if regulators, who might be signalling being agreeable to this idea, actually buy in to it. Try catching that wave a little late. Lol.
By the way, this trial has taken so long and seems to have been planned to be since 2014/2015 that a rolling BLA seems like it could have been put in play if NWBO felt they had a winner for a while. Seems like the outline could have been done already. Like you have said, the data has been basically set in stone even if comparative data for reimbursement purposes later on may show some "optimization" differences in German data. Best wishes.
