Jun. 9 at 12:59 AM
$INO The facts that no bagholding pumper has ever, not once proven different.
1) Inovio was told by the FDA that they don't have the data to support accelerated approval.
2) Combo therapeutics have a rough time getting approval 1st time and the Cellectra device already has a history of issues. Time & $$$
3) CEO said she would not go the standard approval route, likely because of lack data needing a P3 trial, and possibly blinded. Time & $$$
4) Inovio is broke, needs another offering very soon just to stay afloat and definitely doesn't have the cash to commercialize if miracle approval.
5) Even before the next offering with more warrants, there's 3 big tranches of warrants @
$1.40 ,
$1.75 , and
$3.76 . Expect 2 more offerings with more warrants this year alone.
6) If approved the label will be restricted as a step therapy to Papzimeos who already has broad label approval since Aug 25' and J-Code since last April. Oh, and Ophan Designation.
7) CONT'D... for VGX-3100