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Re: biosectinvestor post# 392560

Friday, 07/30/2021 10:26:28 PM

Friday, July 30, 2021 10:26:28 PM

Post# of 701423
I thought it was clear that I was making an observation and speculating, but thanks for clarifying if that was not clear.

I would think that Cognate would have run the equivalency studies for cryopreserved leukapheresis material during the trial, but keeping that language in the annual reports long after the trial was completed made me think otherwise. It’s encouraging that Northwest Bio finally addressed the need for automated manufacturing with the Flaskworks’ purchase (NEARLY A YEAR AGO) but the speed with which they operate is frustrating, and this does make me wonder if their limited resources have prevented them from addressing other manufacturing issues in a timely manner. I’m quite confident that they will eventually receive regulatory approval and begin commercial manufacturing, but I’ve begun to think it may be later rather than sooner.

BTW - Do you (or anyone else) have an explanation for the language change from this:

2019 10-K
Our intention is for the U.K. facility to manufacture DCVax products for the whole European region.


to this:

2020 10-K
Our intention is for the U.K. facility to manufacture DCVax products for both the UK and other regions.


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