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Tuesday, July 15, 2025 12:17:46 PM
original email at bottom---
"NWBO confirmed via SEC filing on December 20, 2023 that it submitted a full MAA, "
THAT WAS 19 MONTHS AGO!!! A lot has changed since, like the change in PIP trials for 1 example
Also, My original email to MHRA received a response to further my future enquiries to the VARIATION DEPT, (WHY?) and then VARIATION DEPT responded! I didn't ask to speak to the variation Dept, MHRA customer Svc directed me there!!! (WHY?)
My point is not that I know anything because only the company has access to the Regulatory Connect Portal, My point was that DCVAX "seems" to be in the VARIATION Dept. or I would never have been referred to them! (Maybe somebody there messed up, IDK) I am just posting what I have received.
I have time stamped email records of everything. You are not succeeding in threatening me. I have no position in this stock and never have, therefore I have no reason to lie, make things up or alter emails.
And NICE TRY THOUGH
Latest 10K 👇️
Pediatric Brain Cancer Trial. The Company worked throughout the year to obtain engagement of pediatric neurosurgeons and neuro-oncologists for the pediatric trial that is legally required in connection with the MAA application for adult patients. The clinicians requested substantial changes in the trial design and plans that had been approved by MHRA. After a long process, a new trial design was agreed by the clinicians. The Company plans to obtain MHRA approval of the new design and move forward with the trial in due course.
Thank you for your email.
We have reviewed your request and will need to direct your query to our colleagues in the relevant team for further input.
In the meantime, should you have any other questions or requests please feel free to call us on 0203 080 7400 or email at variationqueries@mhra.gov.uk
"NWBO confirmed via SEC filing on December 20, 2023 that it submitted a full MAA, "
THAT WAS 19 MONTHS AGO!!! A lot has changed since, like the change in PIP trials for 1 example
Also, My original email to MHRA received a response to further my future enquiries to the VARIATION DEPT, (WHY?) and then VARIATION DEPT responded! I didn't ask to speak to the variation Dept, MHRA customer Svc directed me there!!! (WHY?)
My point is not that I know anything because only the company has access to the Regulatory Connect Portal, My point was that DCVAX "seems" to be in the VARIATION Dept. or I would never have been referred to them! (Maybe somebody there messed up, IDK) I am just posting what I have received.
I have time stamped email records of everything. You are not succeeding in threatening me. I have no position in this stock and never have, therefore I have no reason to lie, make things up or alter emails.
And NICE TRY THOUGH
Latest 10K 👇️
Pediatric Brain Cancer Trial. The Company worked throughout the year to obtain engagement of pediatric neurosurgeons and neuro-oncologists for the pediatric trial that is legally required in connection with the MAA application for adult patients. The clinicians requested substantial changes in the trial design and plans that had been approved by MHRA. After a long process, a new trial design was agreed by the clinicians. The Company plans to obtain MHRA approval of the new design and move forward with the trial in due course.
Thank you for your email.
We have reviewed your request and will need to direct your query to our colleagues in the relevant team for further input.
In the meantime, should you have any other questions or requests please feel free to call us on 0203 080 7400 or email at variationqueries@mhra.gov.uk
Recent NWBO News
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 09:00:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
