Not at all
Up until the time of the initial btd submission back in sept
pIII with spa was the agreed route if my memory serves me
The patents were done
It is my understanding, though I have no proof, that the FDA thought pvct would be a good candidate for btd
Let me digress that in past conversations I have had that it is pvct modus operandi not to waste time or money on any trial without the FDA's guidance and permission. I base all my assumptions in other posts on this. They are very adamant on this. So if you see them doing something, saying something, not saying something, not doing something then you bet your dollar the FDA is aware and may be guiding them to do so.... My opinion!
That being said it is my understanding that the FDA said start the btd process
That made pIII obsolete because pIII was already agreed to
They just had to wait on the patent to go forward
Why then the FDA said go on btd and not earlier?.... Damn if I know the mind of government
But the drug you use going out the door has to be the one you use past pII
Now logic would say it better be damn near identical to the ones used in pI and pII
The current one uses 99.9% pure rb vs a less pure rb
The new formulation is pure enough to be accepted internationally for oncology
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