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exel_mm

08/30/17 12:29 PM

#31589 RE: Meishairwin #31587

Hey Meishairwin, news flash for you in case you didn't know:
The science just works. You know, like the Nike slogan "Just Do It"?

"Advaxis, it just works"

All your other rhetoric is best suited for vanilla ice cream. We're talking about tiramisu or creme brulee here...
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gajj

08/30/17 12:48 PM

#31594 RE: Meishairwin #31587

answer 9 months or less following EU submission
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mpreorder

08/31/17 8:03 PM

#31821 RE: Meishairwin #31587

I did some research and analysis a while back trying to determine when approval may occur.
In summary -
Advaxis submits for approval sometime in 4qtr.
EU has 6 months to respond - clock starts on submission
There can be up to 2 "time outs" - used for company to respond to questions - of up to 3 months each.
Therefor the latest we know is end of 2018.

If Advaxis has the submission in pristine form, submits closer to the beginning the 4th qtr, doesn't need to use any time outs AND the science is acceptable - we can be looking at EU approval as early at mid 2018, less than a year away.
Personally I give a 70% chance it'll about a year from now.

So I can't agree with your mid 2019 suggestion. But, what do you think will happen UPON submission?? This will occur THIS year, and my experience with DNDN tells me the run up will occur well before the EU even responds.
This is a serious question to you as I (and most of the message board) value your insights.