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anders2211

09/20/21 10:23 AM

#402980 RE: MI Dendream #402950

with the MHRA and any RA's only a business/organization represented by a person can submit a license or permit. The business needs to be registered with the chamber of commerce (companies house in the UK) and needs to be acknowledged by the tax authorities (has to be in possession of a TAX number). The MHRA needs to hold someone or a company liable or responsible if something would go wrong during the Good Manufacturing Practice and can't, and I can't even believe we are having this discussion here, hold a property responsible for Bad Manufacturing Practice.

Organisations that may have to comply with good manufacturing practice (GMP) and/or good distribution practice (GDP) include:

manufacturer licence holders
wholesale dealer licence holders
blood establishment authorisation holders
non-UK sites employed by UK MA holders
MHRA carries out inspections to check if manufacturing and distribution sites comply with GMP or GDP. You will be inspected when you apply for a manufacturer or wholesaler dealer licence and then periodically based on risk assessments. Overseas manufacturing sites are also inspected.

If an organisation manufactures or distributes both human and veterinary medicines, MHRA may carry out an inspection of both areas on behalf of the Veterinary Medicines Directorate.

https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice

That company/organization submitting the request for a license for Good Manufacturing Practice is either Northwest or Advent Bioservices for the Sawston facility. Given the in my view somewhat misleading text in the May 12 and Mar 16 PR of NWBO I understand that some longs here keep holding the belief that it's NWBO that requested for that manufacturer license holders, but it turns out that its Advent. If you read the text carefully in both PR's nowhere it is mentioned that it is NWBO that submitted the request for the license. I call that misleading

And Yes I call that the built out or the expansion of Advent Bioservices, LP's/Toucans own private business. Since its NWBO that facilities, the property and the equipment its at the expense of NWBO shareholders IF Advent does not pay a fair price for using that equipment and property then I call that self-dealing once again.

LP has 800 million good reasons not to share Advent with NWBO sharholders

FWIW

I believe that DCVAX L will be approved and I believe NWBO will be sold for at leats 22 billion if not more. Thats why Im still long in NWBO