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Monday, March 16, 2020 11:45:39 PM
Sounds like they are confident of approval if there is a “need to negotiate a new agreement with Cognate in 2020 for production of DCVax-L products for commercial purposes and new programs.” Wonder what the new programs are.
I would agree that the current language indicates that the SAP work has been completed, but quite honestly, I would be surprised and very disappointed if it wasn’t by now.
I have to admit that I would have preferred different language than “The Company is continuing to consult with its Scientific Advisory Board, independent consultants and the Board of Directors to move forward as prudently and expeditiously as possible to data lock, unblinding and top line data.” While it doesn’t really elaborate where they actually are in the process, that language indicates to me that they haven’t yet reached data lock.
And yes, it is noteworthy and odd that “Item 10, Directors, Executive Officers And Corporate Governance” section was left blank and will be incorporated in the Proxy Statement. I doubt the reason for this is “blah” or they would have just copied last years. I will speculate that this will fall under the “interesting” category.
One other difference is that new patents were issued last year:
The 2019 10-K stated:
As of December 31, 2018, we have over 190 issued patents and more than 65 pending patent applications worldwide, grouped into 12 patent families. Of these, 181 issued patents and 35 pending patent applications directly relate to our DCVax products.
During 2018, two new patents were issued to us as part of our worldwide patent portfolio. The newly issued patents cover methods and devices for manufacturing dendritic cells related to our DCVax products, as well as encompassing certain dendritic cell compositions for direct injection into patient tumors related to our DCVax-Direct product.
The 2020 10-K:
As of December 31, 2019, we have 199 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families. Of these, 191 issued patents and 52 pending patent applications directly relate to our DCVax products.
During 2019, six new patents were issued to us as part of our worldwide patent portfolio. The newly issued patents cover methods and devices for manufacturing dendritic cells related to our DCVax products, as well as encompassing certain methods and compositions that may be potential future markets related DCVax products.
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