News Focus
News Focus
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newman2021

08/10/24 9:45 AM

#711987 RE: beartrap12 #711971

Amazing. August Q10 revealing the status of the EDEN sys housing GMP compliant FW units in a large cSuite is an amazing development and seeing it going to reduce the footprint shortly will be a humongous achievement in the emerging world of personalized cell therapy manufacturing that no one else can reach these heights for a foreseeable future, imo. There can be as much as a 75% cost cutting here compared to the artisan method, imo. DcVaxL will rule the oncology space,imo, longs. Cheers!
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antihama

08/10/24 10:08 AM

#711991 RE: beartrap12 #711971

I would say Probably and Yes.

It's hard for me to tell from this comment if they were successful with reducing the footprint and if they Eden units are ready for production.

I think of it as a car manufacturer rolling out a brand new model. They'll sell this model for a few years, and while selling it, continue to make improvements that will be incorporated in the next upgrade. Regulatory wise these changes will be captured w a Change Control procedure/documentation. The key is that it's now GMP.
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beartrap12

08/10/24 10:17 AM

#711995 RE: beartrap12 #711971

Another big difference between yesterday's Q10 and the one in May had to do with a going concern for necessary supplies. I looked at this going back to the Annual report released in March. This is what was written.

Supply Chain issues:

August 24: no comment (that I could find anywhere in the Q10)

May 24:

The Company’s programs and operations continue to be impacted by supply chain issues and backlogs which, surprisingly, have still not substantially resolved. These involve service firms and also vendors and suppliers of a wide variety of items, ranging from major equipment to particular reagents required for the manufacturing process. Shortages of certain key materials and supplies have also occurred. The Company is hopeful that the various backlog circumstances will improve over the course of 2024.



March Annual report 24

Supply chain issues and equipment backlogs continue to be factors affecting operations both for Advent and for Flaskworks. However, the work of both Advent and Flaskworks is progressing in spite of these issues.



I hope the lack of comment on supply-chain issues means they are being resolved. I've believed for a while now that the sooner we got to marketing approval, the sooner we could negotiate deals with supply companies, and the sooner these supply chain issues would disappear. I doubt that management "forgot" to address this issue which has come up repeatedly in the quarterly reports. I suspect they have agreements ready and waiting for the MHRA to make its final decision on our application. Obviously, it would not be smart to sign a supply agreement without a marketing approval.
Bullish
Bullish
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flipper44

08/10/24 10:33 AM

#711999 RE: beartrap12 #711971

“The difference is that we overcame the (Eden) cleaning and safety issues and now have a product that is GMP-compatible. That's major!” — beartrap

True. Arguably the most important point in yesterday’s 10Q.