Wednesday, August 30, 2017 12:28:36 PM
Resubmitting is only the first step in a possible long road. FDA has to accept the resubmission ( 2 month time frame ) and then make a decision ( 6 month time frame after that ).
-End of October for possible FDA acceptance of the NDA resubmission.
-End of April for FDA decision on NDA resubmission.
This is where things can get sticky.
A few of the people left here were calling for a HUGE pop ( compared to where the share price was a couple of months ago ) after filing. Did it happen after filing? No
It can still happen but this is also where it can turn bad for Apricus also. They can get an acceptance from the FDA to review the NDA in a two months only to get a CRL ( Complete Response Letter ) 6 months after that. And then it's back to the drawing board.
Can they put off another capital raise if another CRL is issued?
I am 100% certain that they will do a capital raise if Vitaros is approved ( but in this case - it would not seem too bad for current shareholders as it would certainly be at a higher share price than current levels ).
Good Luck
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