Friday, March 08, 2019 10:20:22 AM
I like the idea of licensing of L as well. I think most of the issues you describe, though, will fall back onto manufacturers like Cognate, Fraunhofer or Advent. Each if these entities have had the appropriate training from Cognate already and other contractors are quickly being brought up to speed. There are many qualified administration sites in Europe now that can open for medical tourism while other sites become qualified. In the US and Canada there are sufficient qualified sites also. The Asian market would need a solid partner to get up to speed. As expansion into other indications occur then further partnering or licensing and site qualification training would be needed. Your concern that they would need big pharma talent and expertise is valid but I think that talent will jump ship to NWBO or affiliates very quickly as they see the writing on the wall. Some may try to come in as spies but I expect thorough vetting of potential employees. I also think regulators, pushed by patient advocate groups, will do everything in their power to help get this to patients once approved as they don't want to be seen as an impediment to potentially life saving treatment and incur the wrath of patients and their families. The speed of approval can be somewhat regulated but once patients understand that Direct is the "same" product as L there will be an overwhelming demand for it to be put into use as a safe, potentially life saving treatment. Regulators need an uninformed public for a little while longer to get their ducks all in a row as they and legislators have dragged their feet for big pharma status quo longer than they should have and now have much time to make up or they will have their feet held to the fire so to speak. NWBO will make it blatantly clear that they are not to blame for delays to patient access to their products. Mr. Cofer Black will make sure of that. I am absolutely certain that he has a really good story to tell now and that story will be used as motivation for one and all who have stood in the way of this technology reaching patients just like water boarding and other techniques were used in Iraq and elsewhere. This is going to be good and I expect some "exceptionally motivated" licensing or partnering offers from at least one or more pharmas whose potential connections to nefarious activities might otherwise be exposed. A three year investigation must have hit some serious pay dirt especially with so many resignations seen along the way. Lol. Best wishes.
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