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Re: fbg0316 post# 52577

Tuesday, 02/06/2018 12:17:51 PM

Tuesday, February 06, 2018 12:17:51 PM

Post# of 108192
Re: ADXS NEO amendment

[ADXS] said...they were amending the partnership agreement [with AMGN] related to manufacturing.

I think you misinterpreted what you heard. The NEO amendment ADXS mentioned on the FY4Q17 CC was an amendment to the IND filing with the FDA, not an amendment to the partnership agreement with AMGN. Here's the relevant excerpt:

https://seekingalpha.com/article/4133327-advaxis-adxs-ceo-anthony-lombardo-q4-2017-results-earnings-call-transcript?part=single

The FDA has cleared the initial IND application of NEO and we will file an IND amendment in early 2018. This amendment is largely driven by enhancements to the manufacturing and antigen selection processes. We do not expect this to impact our project timelines and we have a pathway to maintain our Phase 1 study initiation in the first half of 2018. We look forward to updating you on our progress.


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