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Re: Lykiri post# 671455

Monday, 02/12/2024 11:10:17 AM

Monday, February 12, 2024 11:10:17 AM

Post# of 700405
Thanks Lykiri (and pgsd), interesting comments from a couple of highly qualified GMP manufacturing experts, right? Sounds like they are helping Advent and Flaskworks to achieve automated commercial manufacturing readiness.

Drew’s comment, “Great hope for patients with glioblastoma and really exciting news for me and my colleagues as we progress towards marketing authorisation of this ATMP from Advent Bioservices' Cambridge manufacturing site,“ makes me wonder why this group from another company would be so excited for Northwest Bio’s marketing approval, and why he uses the phrase, “as we progress.” Do you suppose that Northwest Bio is paying these consultants with shares of NWBO?

Here’s their qualifications:

Drew Hope is a Senior GMP Compliance Consultant at eXmoor pharma which helps companies to “understand, plan, and implement the appropriate CMC strategy.” Their relevant specialties are: Cell Therapy, Process Engineering, Process Development, Concept Design, GMP Compliance, Bioprocess Engineering, Manufacturing Strategy, Advanced Therapies, and Clinical GMP Manufacture.

Reinout Hesslink is a consultant with over 17 years of experience and an emphasis on CMC, product development and quality control in the field of cell and gene therapies. He has had senior roles at PharmaCell (Lonza) and DCPrime, where he optimized production process development focused on scalability and sustainability. He helped compiling ATMP regulatory filings for both early and late stage clinical trials for companies like DCPrime, Iovance, and Orchard Therapeutics, and managed cell and gene therapy contract manufacturing at BioNTech. As a consultant he has focused on the development of cell and gene therapies and their production process from early clinical up to commercial products.


Anyway, I know why the Flaskworks’ owners might be excited. In case no one else noticed, (besides me and exwannabe) that last PR basically indicated that Flaskworks’ 2nd milestone for the vesting of 25% of their share’s rights from the acquisition, was finally reached. Curious if it occurred in the 4th quarter or the 1st quarter, and if it will be mentioned in the 10K or 10Q. Recall:

(ii)Twenty-five percent (25%) of the Rights shall vest upon the demonstration to the Company’s reasonable satisfaction that the EDEN system can replicate the Company’s current DCVax-L manufacturing process as verified by yield, phenotype and functional assay data.

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