flipper44, you must have been a regulatory pro in a past life. NWBO has all the elements to work with here incl r and n data, the new matured combo data, a mfg plan to dramatically expand capacity apparently ready to go, and clinical data that spans a decade and have been published. There is a reason NWBO went to MHRA vs FDA as its initial approval filing, which we will never fully understand, though we can surmise, but I think FDA will respond rapidly and strongly when NWBO decides to take their approval package to them. It is not uncommon for a company to have to expand capacity to respond to their demand growth curve and the plan NWBO has developed I am sure is completely acceptable to the RA's on multiple levels.
It will be very interesting to see the regulatory pathway(s) NWBO now utilizes. The scenario you paint is quite possible. I believe once the first approval is gained the progress will accelerate very rapidly and NWBO can take the most conservative route with r approval first with FDA or they can take the most aggressive route with the combo data if FDA wants to jump ahead of the base product approval. These are regulatory calls which NWBO may be calling you to help with.
I think and hope for all cancer patient's sake that FDA gets aggressive as soon as NWBO approaches them, given the benign safety profile here and the potential to build a platform of new cancer treatment across solid tumors.
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