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Re: mypekeispooped post# 24198

Friday, 06/23/2017 12:28:54 PM

Friday, June 23, 2017 12:28:54 PM

Post# of 108192
I suspect our conversations were very similar. Also, I have always felt that for Advaxis to move forward with the application for the EMA based on P2 data, the company has to be pretty confident of approval based on their conversations with the agency. After speaking with Noelle, I get the feeling that they are confident. That said, anything can happen to delay the process (e.g. additional questions from the agency). But, I sense management feels good about their chances for approval. It is also possible that approval could come before 270 days. She did reiterate that the submission will be in the 4th quarter and that the company wants to have a plan in place for marketing and distribution well in advance of any approval.
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