Well Si had been using very play it safe language and approach the last few years and only up until the last 3 months. Some would say he has been ambiguous in order in language in the previous 2 to 3 years to not falter from a legal standpoint.
That play it safe language is now pretty much fully gone!
Destination language for BLA and approval said.
Revert to original plan said. (This is huge from a legal standpoint)
Off label use for Adults is the way we will go…said.
Pay down some debt while we are at it said and done. As they seem to have excess needs for the money now! That is quite telling.
Dates being met, no mention of issues of cashflow, operational spend down, BOD buying shares. How much better can it be.
It is all becoming very easy all of a sudden after that last FDA meeting - pivotal meeting is an understatement.
Yesterday’s quarterly update was more confirmation of background FDA support after that FDA last meeting.
The plan is in place.
Onwards and upwards is an understatement now.
Well Si had been using very play it safe language and approach...
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