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Re: James salmon post# 18961

Tuesday, 04/25/2017 10:33:17 PM

Tuesday, April 25, 2017 10:33:17 PM

Post# of 108192
james, I would love to see approval before 2018 but I think Feb-May, 2018 is more likely. We have an "up to" 150 active day scientific evaluation assessment after MAA submission. The CHMP must then issue their "scientific opinion" (which no timeframe is given). After which the opinion for the go ahead (assuming its positive) is THEN given to the European Commission which in turn they have within 67 days of receipt of CHMP's decision to issue MAA. From what i can tell there is much dialogue back and forth before the submission of the MAA application which is why Advaxis has not submitted the application....say... yesterday. I do understand the optimism and the days previously mentioned are, and I quote "Up to" and "Within" so....maybe? BUT, that is 217 days at the latest PLUS however long the CHMP takes to make their decision, if we filed the application tomorrow. Per ADXS, they do not plan on filing till early 2nd Half 2017.

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