As to your question, was there an SAP with the IND. you appear not able to understand the process and how any of this works. You both are creating noise. No one needs entertain your noise.
Yes, an SAP is included with an initial IND. and yes, there are procedures for updating and even having a more flexible trial. And in fact, during the litigation, NWBO outlined how many times they updated their clinical trial protocols along the way substantially.
So yes, there was a fairly adaptive process involved. This is not uncommon with biological or immune therapies. The FDA is not frozen in 1950. It is constantly updating and moving to address the rapid challenges that are arising as technology and knowledge mushroom into whole new paradigms during the course of very long trials particularly.
To try to set out a dated paradigm, not even in detail, just a presumption, and insist that that is “the norm”, is not correct. Period. It is not even necessarily consistent with these facts not how large and very established pharmaceutical companies exist or many other smaller ones.
So yes, you guys need to educate yourselves. Instead you’re standing on a hill throwing stones and boulders.... supposedly because you’re just helping...really, you’re just making a lot of noise and demanding attention.
No, I’m no old man, I just do not like people who spend all day here wasting people’s time.
Market Data 
Markets 
AI
