Board: sharing some questions I presented to Dave Innes today. see my questions below regarding Sawston updates and if NWBO is on a 1 year timeline of releasing TLD set by FDA.
Re: NWBO Sawston Inspection and initial practice runs
From Dave Innes on 2021-08-02 1:08 pm
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Can't give you a timeline on the above but as events unfold we will bring everyone up to speed at the same time. There has been a lot of talk about HR 11.44 but we have not made any public statements on the subject. We did update in Mid May and said everything is proceeding on the items that need to be completed to get to TLD and a scientific publication. We also gave a very nice update on Sawston production.
Stay tuned.
Dave
Sent from my iPhone
On Aug 2, 2021, at 12:58 PM, David Reed xxxxxxxxxxxitgroup.com> wrote:
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Hello xxxx
Are you allowed to provide any color from the last PR you presented in March? ( Meant to say May)
Wonder if the onsite inspection was done and initial practice runs completed as per the PR section below.
Lastly, is there a 1 year timeline that NWBO must adhere to for releasing TLD set by the FDA? There seems to be conflict on that from many Shareholders.
"The next step will be an on-site inspection of the facility by MHRA. Following the inspection, a report of the inspection results and any findings needing any corrective action will be issued by MHRA. Following completion of any actions, the Company is hopeful that an initial license will be issued and production of GMP DCVax-L products in the Sawston facility may begin by around the end of Q3.
In addition to the MHRA submission activities, a prototype of the Flaskworks system has been delivered to the Sawston facility, and the Company currently anticipates that initial practice runs with the system may begin at the Sawston facility during the summer."
Thank you!!
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