sentiment_stocks,
The control patient numbers were always a concern because of crossover so that had to be dealt with anyway which was a long standing bear argument. That process was going to lead to a necessary buy-in from regulators apart from needing to deal with treatment related pseudoprogression.
As much as NWBO talked about manufacturing being their strength, demand for L always had the potential as a platform tech to outstrip clean room capacity which seems to be limited by technical expertise under the artisan method. Therefore, no BLA could be approved until a pathway for manufacturing at commercial scale for anticipated demand could be found and as flipper44 has shared, SOC consideration and off label use is a whole different level of demand. DNDN never had to deal with those issues. We are just now getting to the point where commercial scale operations for SOC demand are scalable and approvable. Time to develop the process and get approvals, more than money, was the issue to get here so FDA was not really in the way with this major issue.
In my opinion NWBO did this all in stealth mode partially to keep others off their trail and to keep some competition from creating more interference along the way. Your points about Dr Furberg, his brother and some at FDA being on the wrong side of things I believe are all very likely and a little quiet house cleaning at FDA also ensued after all the ruckus. Thank you Mr Coffer Black?
We all come from different perspectives and it’s good for others to look at them all knowing that we may differ somewhat about how we got here but agree about what’s ahead for the benefit of cancer patients and where this company is going ; ). Best wishes.
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